NEW DIRECTIONS

e Ethics of Synthetic Biology 

and Emerging Technologies

December 2010

Presidential Commission 

for the Study of Bioethical Issues

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NEW DIRECTIONS

e Ethics of Synthetic Biology 

and Emerging Technologies

Washington, D.C.

December 2010

www.bioethics.gov

Presidential Commission 

for the Study of Bioethical Issues
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

iiii

On the front cover: Portion of the genome map of M. mycoides JCVI-syn1.0. From Gibson, D.G., et al. (2010). 

Creation of a bacterial cell controlled by a chemically synthesized genome. Science 329(5987):52-56.

About the Presidential Commission for

the Study of Bioethical Issues

The Presidential Commission for the Study of Bioethical Issues (PCSBI) is 

an advisory panel of the nation’s leaders in medicine, science, ethics, religion, 

law, and engineering. PCSBI advises the President on bioethical issues arising 

from advances in biomedicine and related areas of science and technology. 

The Commission seeks to identify and promote policies and practices that 

ensure scientific research, health care delivery, and technological innovation 

are conducted in a socially and ethically responsible manner.

For more information about PCSBI, please see www.bioethics.gov.
iii

CONTENTS

Letter of Transmittal to the President...........................................................................v

Letter from the President to the Commission...........................................................vi

Members of the Commission........................................................................................vii

Commission Staff ............................................................................................................viii

Acknowledgements............................................................................................................ix

Executive Summary ...........................................................................................................1

Chapter 1 Introduction..........................................................................................19

Chapter 2 Science of Synthetic Biology.............................................................35

Chapter 3 Applications, Benefits, and Risks....................................................55

Chapter 4 Oversight................................................................................................79

Chapter 5 Analysis and Recommendations ................................................... 111

Public Beneficence.............................................................................113

Responsible Stewardship .................................................................123

Intellectual Freedom and Responsibility ....................................141

Democratic Deliberation................................................................. 151

Justice and Fairness...........................................................................161

Appendix: Guest Speakers............................................................................................175
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

iv
v

1425 NE W YO R K AV E N U E, NW, S U I T E C-100, WA S H I N G T O N , DC 20005 

P H O N E 202-233-3960 F A X 202-233-3990 W W W.B I O E T H I C S . G O V

PR E S I D E N T I A L CO M M I S S I O N F O R T H E ST U D Y O F BI O E T H I C A L IS S U E S

President Barack Obama 

The White House 

1600 Pennsylvania Avenue, NW 

Washington, DC 20500 

Dear Mr. President: 

We are pleased to present to you this report, New Directions: The Ethics of Synthetic Biology and Emerging 

Technologies. In response to your request of May 20, 2010, this first report of the Presidential Commission for 

the Study of Bioethical Issues (PCSBI) examines the implications of the emerging science of synthetic biology, 

including the announcement in May of the successful creation of a self-replicating bacterial cell with a 

completely synthetically-replicated genome. It offers recommendations to ensure that America reaps the benefits 

of this developing field within appropriate ethical boundaries. 

PCSBI approached this task through inclusive and deliberative engagement with ethicists, scientists, engineers, 

and individuals in faith, business, and non-profit communities. We held three public meetings, both in and 

outside of Washington, D.C., created an open forum for dialogue, and heard many diverse voices. 

The Commission found that synthetic biology offers extraordinary promise to create new products for clean 

energy, pollution control, and medicine, to revolutionize chemical production and manufacturing, and to create 

new economic opportunities. With this promise comes a duty to attend carefully to potential risks, be 

responsible stewards, and consider thoughtfully the implications for humans, other species, nature, and the 

environment. 

PCSBI concluded that synthetic biology is capable of significant but limited achievements posing limited risks. 

Future developments may raise further objections, but the Commission found no reason to endorse additional 

federal regulations or a moratorium on work in this field at this time. Instead, the Commission urges monitoring 

and dialogue between the private and public sectors to achieve open communication and cooperation. 

The Commission recommends that the government, through a coordinated process or body within the Executive 

Office of the President, lead an ongoing review of developments, risks, opportunities, and oversight as this field 

grows. This review should be in consultation with relevant scientific, academic, international, and public 

communities, and whenever possible its results should be made public. We also recommend that reasonable risk 

assessment should precede any field release of synthetic organisms. We suggest support for public engagement, 

education, and dialogue to ensure public trust and avoid unnecessary limitations on science and social progress. 

You gave the Commission a rare and exceptional opportunity to be proactive and forward looking in this first 

study. The Commission is grateful for the opportunity to serve you and the nation in this way. We would be 

happy to brief you if you have any questions about our recommendations. 

 Sincerely, 

 Amy Gutmann, Ph.D. James Wagner, Ph.D. 

Chair Vice-Chair
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

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vii

PRESIDENTIAL COMMISSION FOR THE STUDY

OF BIOETHICAL ISSUES

AMY GUTMANN, PH.D., CHAIR

President and Christopher H. Browne

Distinguished Professor of Political Science, University of Pennsylvania

JAMES W. WAGNER, PH.D., VICE CHAIR

President, Emory University

YOLANDA ALI

Michael J. Fox Foundation

Founder’s Council; 

Emory Neurosciences

Community Advisory Board

ANITA L. ALLEN, J.D., PH.D.

Deputy Dean for Academic Affairs;

Henry R. Silverman Professor of Law,

Professor of Philosophy, University 

of Pennsylvania Law School

JOHN D. ARR AS, PH.D.

Porterfield Professor of Biomedical

Ethics, Professor of Philosophy,

University of Virginia

BARBAR A F. ATKINSON, M.D.

Executive Vice Chancellor,

University of Kansas Medical Center; 

Executive Dean, University of 

Kansas School of Medicine

NITA A. FAR AHANY, J.D., PH.D.

Associate Professor of Law, 

Associate Professor of Philosophy, 

Vanderbilt University

ALEXANDER G. GARZA, M.D., M.P.H.

Assistant Secretary, Office of Health

Affairs; Chief Medical Officer, 

Department of Homeland Security

CHRISTINE GR ADY, R.N., PH.D.

Acting Chief of the Department of 

Bioethics, National Institutes of Health 

Clinical Center

STEPHEN L. HAUSER, M.D.

Robert A. Fishman Distinguished 

Professor and Chair of the Department 

of Neurology, University of California, 

San Francisco

R AJU S. KUCHERLAPATI, PH.D.

Paul C. Cabot Professor, Department 

of Genetics, Harvard Medical School; 

Professor, Department of Medicine, 

Brigham and Women’s Hospital

NELSON L. MICHAEL, M.D., PH.D.

Colonel, Medical Corps, U.S. Army; 

Director, Division of Retrovirology; 

Walter Reed Army Institute of Research; 

U.S. Military HIV Research Program

DANIEL P. SULMASY, M.D.

Kilbride-Clinton Professor of Medicine 

and Ethics, Department of Medicine 

and Divinity School; Associate Director, 

MacLean Center for Clinical Medical 

Ethics, University of Chicago
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

viii

PRESIDENTIAL COMMISSION FOR THE STUDY

OF BIOETHICAL ISSUES 

STAFF AND CONSULTANTS

Executive Director

Valerie H. Bonham, J.D.

Research Staff

Debbie Forrest, M.P.P.

Chris Havasy, Sc.B.

Holly Fernandez Lynch, J.D., M. Bioethics

David G. Miller, Ph.D.

Anne Pierson, J.D. Candidate, 2011

Jason L. Schwartz, A.M., M. Bioethics

Kayte Spector-Bagdady, J.D., M. Bioethics

Consultants

Burness Communications

Alison Davis, Ph.D.

Kathi E. Hanna, M.S., Ph.D.

Administrative Staff

Judith E. Crawford

Esther Yoo, B.A.
ix

Acknowledgements

The Commission thanks the many scientists and scholars who shared their 

time, expertise, and insight with the Commission as it completed this work. 

These include the individuals who participated in its public meetings, listed in 

the Appendix, and those who contributed their thoughts directly to Commission members and staff. 

The Commission is grateful to the members of the public who discussed their 

views during the public meetings and contributed written comments. The 

Commission’s gratitude extends as well to the agency officials who provided 

assistance, often on short notice and under tight deadlines. Special thanks go 

to Alta Charo, Jacqueline Corrigan-Curay, Jason Dietz, Daniel Drell, Michael 

Firko, Bob Hargrove, Freeda Isaac, Theresa Lawrence, Sally McCammon, 

Larisa Rudenko, Greg Schweer, Allan Shipp, Deborah Smegal, Jessica Tucker, 

and Rob Weyandt.

Lastly, the Commission is enormously indebted to its talented staff for their 

expert work and unwavering commitment throughout this study. Valerie H. 

Bonham ably led the staff and guided this report to its timely completion. 

The Commission thanks its other staff members and consultants—Andy 

Burness, Judith E. Crawford, Alison Faith Davis, John Donnelly, Debbie 

Forrest, Kathi E. Hanna, Chris Havasy, Holly Fernandez Lynch, David G. 

Miller, Anne Pierson, Jason L. Schwartz, Kayte Spector-Bagdady, and Esther 

Yoo—for their many important contributions. The Commission also thanks 

Diane M. Gianelli for serving as Acting Executive Director and ably guiding 

the Commission during its formative period.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

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1

executive

summary
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

2

The 21st century is widely heralded as the century of biology. Building on 

the fundamental understanding achieved in the second half of the last 

century, revolutionary advances are expected to improve many aspects of 

our lives, from clean energy and targeted, safer medicines to new industries. 

Prominent among emerging technologies is “synthetic biology,” which aims 

to apply standardized engineering techniques to biology and thereby create 

organisms or biological systems with novel or specialized functions to address 

countless needs. 

The idea of managing or manipulating biology to identify or develop specific 

characteristics is not new. Scientists have used DNA to create genetically 

engineered cells and organisms for many years; the entire biotechnology 

industry has grown around our expanding abilities in this area. The shelves 

of grocery stores across the United States are stocked with genetically engineered foods. Medical testing for genetically linked diseases is widely used 

by people across society.

By contrast, the idea of assembling living organisms wholesale from nonliving parts has intrigued human imagination for centuries with no success 

outside of fiction. For some, that possibility came one step closer last May 

with the announcement that scientists at the J. Craig Venter Institute had 

created the world’s first self-replicating synthetic (human-made from chemical parts) genome in a bacterial cell of a different species. Intense media 

coverage followed, and the announcement ricocheted across the globe within 

hours as proponents and critics made striking claims about potential risks 

and benefits of this discovery and whether it amounted to an early-stage 

example of “creating life.” 

In response, President Barack Obama asked the Presidential Commission for 

the Study of Bioethical Issues (the Commission) to review the developing field 

of synthetic biology and identify appropriate ethical boundaries to maximize 

public benefits and minimize risks. The Commission approached this task 

through inclusive and deliberative engagement with a wide variety of sources, 

including scientists, engineers, faith-based and secular ethicists, and others 

who voiced, as expected, sometimes conflicting views on the science, ethics, 

and social issues surrounding synthetic biology. Through public meetings 
executive summary

3

in Washington, D.C., Philadelphia, and Atlanta, the Commission created 

a forum for open dialogue to hear and assess competing claims about the 

science, ethics, and public policy relating to synthetic biology. 

What the Commission found is that the Venter Institute’s research and synthetic biology are in the early stages of a new direction in a long continuum 

of research in biology and genetics. The announcement last May, although 

extraordinary in many ways, does not amount to creating life as either a scientific or a moral matter. The scientific evidence before the Commission showed 

that the research relied on an existing natural host. The technical feat of 

synthesizing a genome from its chemical parts so that it becomes self-replicating when inserted into a bacterial cell of another species, while a significant 

accomplishment, does not represent the creation of life from inorganic 

chemicals alone. It is an indisputable fact that the human-made genome was 

inserted into an already living cell. The genome that was synthesized was also 

a variant of the genome of an already existing species. The feat therefore does 

not constitute the creation of life, the likelihood of which still remains remote 

for the foreseeable future. What remains realistic is the expectation that over 

time research in synthetic biology may lead to new products for clean energy, 

pollution control, and more affordable agricultural products, vaccines, and 

other medicines. The Commission therefore focused on the measures needed 

to assure the public that these efforts proceed with appropriate attention to 

social, environmental, and ethical risks. 

President Obama gave the Commission a rare and exceptional opportunity 

in the world of presidential bioethics commissions to be forward looking 

instead of reactive. We are ahead of the emerging science, and this unique 

opportunity underscores the need for the government to act now to ensure a 

regular, ongoing process of review as the science develops. The Commission 

calls on the government to make its efforts transparent, to monitor risks, to 

support (through a peer-review process) the most publicly beneficial research, 

and to educate and engage with the public as this field progresses. The government must regularly review risk assessment and other issues as the science of 

synthetic biology progresses. Only through openness and active engagement 

with all the relevant communities will the government ensure ongoing public 

support and appropriate oversight. The Commission emphasizes the need to 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

4

engage the public over time through improved science education, a publicly 

accessible fact-checking mechanism for prominent advances in biotechnology, 

and other efforts promoting clearer communication on the state of science. 

Basic Ethical Principles for Assessing Emerging Technologies

To reach its recommendations, the Commission identified five ethical principles relevant to considering the social implications of emerging technologies: 

(1) public beneficence, (2) responsible stewardship, (3) intellectual freedom 

and responsibility, (4) democratic deliberation, and (5) justice and fairness. 

The principles are intended to illuminate and guide public policy choices to 

ensure that new technologies, including synthetic biology, can be developed 

in an ethically responsible manner.

The ideal of public beneficence is to act to maximize public benefits and minimize public harm. This principle encompasses the duty of a society and its 

government to promote individual activities and institutional practices, 

including scientific and biomedical research, that have great potential to 

improve the public’s well-being. Public beneficence requires that when seeking 

the benefits of synthetic biology, the public and its representatives be vigilant 

about risks and harms, standing ready to revise policies that pursue potential 

benefits with insufficient caution. 

The principle of responsible stewardship reflects a shared obligation among 

members of the domestic and global communities to act in ways that demonstrate concern for those who are not in a position to represent themselves 

(e.g., children and future generations) and for the environment in which 

future generations will flourish or suffer. Responsible stewardship recognizes 

the importance of citizens and their representatives thinking and acting collectively for the betterment of all. Importantly, it calls for prudent vigilance, 

establishing processes for assessing likely benefits along with assessing safety 

and security risks both before and after projects are undertaken. A responsible 

process will continue to assess safety and security as technologies develop and 

diffuse into public and private sectors. It will also include mechanisms for 

limiting their use when necessary.
executive summary

5

Democracies depend on intellectual freedom coupled with the responsibility of 

individuals and institutions to use their creative potential in morally accountable ways. Sustained and dedicated creative intellectual exploration begets much 

of our scientific and technological progress. While many emerging technologies 

raise “dual use” concerns—when new technologies intended for good may be 

used to cause harm—these risks alone are generally insufficient to justify limits 

on intellectual freedom. As a corollary to the principle of intellectual freedom 

and responsibility, the Commission endorses a principle of regulatory parsimony, 

recommending only as much oversight as is truly necessary to ensure justice, 

fairness, security, and safety while pursuing the public good. This is particularly 

important in emerging technologies, which by their very definition are still in 

formation and are not well suited for sharply specified limitations. While clear 

guidelines to protect biosecurity and biosafety are imperative, undue restriction 

may not only inhibit the distribution of new benefits, but it also may be counterproductive to security and safety by preventing researchers from developing 

effective safeguards. 

The principle of democratic deliberation reflects an approach to collaborative 

decision making that embraces respectful debate of opposing views and active 

participation by citizens. It calls for individuals and their representatives to 

work toward agreement whenever possible and to maintain mutual respect 

when it is not. Public discussion and debate with open interchange among all 

stakeholders can promote the perceived legitimacy of outcomes, even if those 

outcomes are unlikely to satisfy all interested parties. An inclusive process of 

deliberation, informed by relevant facts and sensitive to ethical concerns, promotes an atmosphere for debate and decision making that looks for common 

ground wherever possible and seeks to cultivate mutual respect where irreconcilable differences remain. It encourages participants to adopt a societal 

perspective over individual interests.

The principle of justice and fairness relates to the distribution of benefits and 

burdens across society. Biotechnology and emerging technologies such as synthetic biology, for good or ill, affect all persons. Emerging technologies like 

synthetic biology will have global impacts. For this reason, every nation has a 

responsibility to champion fair and just systems to promote wide availability of 

information and fairly distribute the burdens and benefits of new technologies. 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

6

Recommendations

With these guiding principles in mind, the Commission considered the array 

of public policy issues surrounding the emerging science of synthetic biology 

and makes the following recommendations. The reasons behind each recommendation are provided in the body of the report, and all readers are urged 

to consider carefully this more comprehensive account. In the cases of recommendations 1, 3, 5, 9, 11, 12, and 17, the Commission recommends ongoing 

review by the government, in consultation with the relevant scientific, academic, international, and public communities, with initial action completed 

within 18 months and made public. Some of these actions could easily be 

completed sooner, and the government is encouraged to do so and make its 

progress public. 

Promoting Public Beneficence

Under the principle of public beneficence, the Commission recommends that 

the government review and make public findings regarding the scope of its 

research funding, especially for risk assessment and ethical and social issues 

raised by synthetic biology. This will promote public engagement and ensure 

needed transparency regarding federal efforts in the field of synthetic biology.

Recommendation 1: Public Funding Review and Disclosure

Through a central body such as the Executive Office of the President, the 

federal government should undertake a coordinated evaluation of current 

public funding for synthetic biology activities, including funding for research 

on techniques for risk assessment and risk reduction, and for the study of 

ethical and social issues raised by synthetic biology. This review should be 

completed within 18 months and the results made public. 

Most potential products of synthetic biology are in very early stages of development. Therefore, basic research is critical to further expansion of this science 

and its effective translation into useful products. Necessary funding decisions 

should be made with the goal of advancing the public good, whether these 

decisions support synthetic biology research or other fields. The Commission 
executive summary

7

does not offer an opinion on the relative merits of particular research directions, but recommends that such decisions receive ongoing evaluation as to the 

state of the science and its potential applications.

Recommendation 2: Support for Promising Research

Advancing the public good should be the primary determinant of relative 

public investment in synthetic biology versus other scientific activities. The 

National Institutes of Health, the Department of Energy, and other federal 

agencies should continue to evaluate research proposals through peer-review 

mechanisms and other deliberative processes created to ensure that the most 

promising scientific research is conducted on behalf of the public.

Information sharing is a critical mechanism for promoting scientific progress and innovation. The principle of public beneficence requires researchers, 

inventors, patent holders, and others to work together to develop creative 

strategies to maximize opportunities for innovation. The government should 

consider best practices and other policy guidance, if needed, to ensure that 

access to basic research results and tasks is not unduly limited.

Recommendation 3: Innovation Through Sharing

Synthetic biology is at a very early stage of development, and innovation 

should be encouraged. The Executive Office of the President, as part of the 

coordinated approach urged in Recommendation 4, should lead an effort to 

determine whether current research licensing and sharing practices are sufficient to ensure that basic research results involving synthetic biology are 

available to promote innovation, and, if not, whether additional policies or 

best practices are needed. This review should be undertaken with input from 

the National Institutes of Health, other agencies funding synthetic biology 

research, such as the Department of Energy and the National Aeronautics 

and Space Administration, the U.S. Patent and Trademark Office, industry, 

academia, and public civil society groups. The review should be completed 

within 18 months and the results made public.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

8

Promoting Responsible Stewardship

The Commission endorses neither a moratorium on synthetic biology until all 

risks are identified and mitigated, nor unfettered freedom for scientific exploration. Instead, the Commission believes that the field of synthetic biology 

can proceed responsibly by embracing a middle ground—an ongoing process 

of prudent vigilance that carefully monitors, identifies, and mitigates potential and realized harms over time. Responsible stewardship requires clarity, 

coordination, and accountability across the government. While new agencies, offices, or authorities are not necessary at this time, the Executive Office 

of the President should lead an interagency process to identify and clarify, 

if needed, existing oversight authorities and ensure that the government is 

informed on an ongoing basis about developments, risks, and opportunities as 

this field grows. This process must be undertaken by an office with sufficient 

authority to bring together all parts of the government with a stake in synthetic biology and be sufficiently authoritative to effectively engage or oversee 

engagement with foreign governments.

Recommendation 4: Coordinated Approach to Synthetic Biology

The Commission sees no need at this time to create additional agencies 

or oversight bodies focused specifically on synthetic biology. Rather, the 

Commission urges the Executive Office of the President, in consultation 

with relevant federal agencies, to develop a clear, defined, and coordinated 

approach to synthetic biology research and development across the government. A mechanism or body should be identified to: (1) leverage existing 

resources by providing ongoing and coordinated review of developments 

in synthetic biology, (2) ensure that regulatory requirements are consistent 

and non-contradictory, and (3) periodically and on a timely basis inform 

the public of its findings. Additional activities for this coordinating body or 

process are described in other recommendations.

Because synthetic biology poses some unusual potential risks, as “amateur” or 

“do-it-yourself” (DIY) scientists and others outside of traditional research environments explore the field, these risks must be identified and anticipated, as 

they are for other emerging technologies, with systems and policies to assess and 

respond to them while supporting work toward potential benefits. 
executive summary

9

Recommendation 5: Risk Assessment Review and Field Release Gap Analysis 

Because of the difficulty of risk analysis in the face of uncertainty—particularly for low-probability, potentially high-impact events in an emerging 

field—ongoing assessments will be needed as the field progresses. Regulatory 

processes should be evaluated and updated, as needed, to ensure that regulators have adequate information. As part of the coordinated approach urged in 

Recommendation 4, the Executive Office of the President should convene an 

interagency process to discuss risk assessment activities, including reasons for 

differences and strategies for greater harmonization across the government. 

It should also identify any gaps in current risk assessment practices related 

to field release of synthetic organisms. These reviews should be completed 

within 18 months and the results made public.

Coordination and careful risk analysis are essential steps for responsible stewardship, but they are not sufficient. There are several additional 

approaches, which are known today and continue to evolve as our abilities 

in this field grow, to limit uncertain risks in synthetic biology. Technology 

can be harnessed to build in safeguards. A number of safety features can 

be incorporated into synthetic organisms to control their spread and life 

span. Surveillance or containment of synthetic organisms is a concrete way 

to embrace responsible stewardship. 

Recommendation 6: Monitoring, Containment, and Control

At this early stage of development, the potential for harm through the inadvertent environmental release of organisms or other bioactive materials 

produced by synthetic biology requires safeguards and monitoring. As part of 

the coordinated approach urged in Recommendation 4, the Executive Office 

of the President should direct an ongoing review of the ability of synthetic 

organisms to multiply in the natural environment and identify, as needed, 

reliable containment and control mechanisms. For example, “suicide genes” 

or other types of self-destruction triggers could be considered in order to place 

a limit on their life spans. Alternatively, engineered organisms could be made 

to depend on nutritional components absent outside the laboratory, such as 

novel amino acids, and thereby controlled in the event of release.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

10

The timing of deliberate release of synthesized organisms into the environment and the need to analyze risks prior to release raises special concern. We 

must proceed carefully, particularly when the probability or magnitude of 

risks are high or highly uncertain, because biological organisms may evolve 

or change after release. For any field release, there must be adequate consideration of risk.

Recommendation 7: Risk Assessment Prior to Field Release

Reasonable risk assessment should be carried out, under the National Environmental Policy Act or other applicable law, prior to field release of research 

organisms or commercial products involving synthetic biology technology. 

This assessment should include, as appropriate, plans for staging introduction or release from contained laboratory settings. Exceptions in limited cases 

could be considered, for example, in emergency circumstances or following 

a finding of substantial equivalence to approved products. The gap analysis described in Recommendation 5 should determine whether field release 

without any risk assessment is permissible and, if so, when.

Synthetic biology is an international enterprise. Oversight and regulatory 

mechanisms should adopt an analogous approach, so that the United States is 

involved in regular discussions with other national and transnational organizations so they may seek coordination and consistency when possible.

Recommendation 8: International Coordination and Dialogue

Recognizing that international coordination is essential for safety and security, the government should act to ensure ongoing dialogue about emerging 

technologies such as synthetic biology. As part of the coordinated approach 

urged in Recommendation 4, the Executive Office of the President, through 

the Department of State and other relevant agencies such as the Department 

of Health and Human Services and the Department of Homeland Security, 

should continue and expand efforts to collaborate with international governments, the World Health Organization, and other appropriate parties, 

including international bioethics organizations, to promote ongoing dialogue 

about emerging technologies such as synthetic biology as the field progresses. 
executive summary

11

Responsible conduct of synthetic biology research, like all areas of biological research, rests heavily on the behavior of individual scientists. Creating a 

culture of responsibility in the synthetic biology community could do more 

to promote responsible stewardship in synthetic biology than any other single 

strategy. There are actors in the world of synthetic biology, namely engineers, 

chemists, materials scientists, computer modelers, and others, who practice 

outside of conventional biological or medical research settings. These groups 

may not be familiar with the standards for ethics and responsible stewardship 

that are commonplace for those working in biomedical research. This poses a 

new challenge regarding the need to educate and inform synthetic biologists 

in all communities about their responsibilities and obligations, particularly 

with regard to biosafety and biosecurity.

Recommendation 9: Ethics Education

Because synthetic biology and related research cross traditional disciplinary boundaries, ethics education similar or superior to the training required 

today in the medical and clinical research communities should be developed and required for all researchers and student-investigators outside the 

medical setting, including in engineering and materials science. As part of 

the coordinated approach urged in Recommendation 4, the Executive Office 

of the President, in consultation with the National Academy of Sciences, the 

National Academy of Engineering, the scientific community, and the public, 

should convene a panel to consider appropriate and meaningful training 

requirements and models. This review should be completed within 18 months 

and the results made public.

Additionally flowing from the principle of responsible stewardship, the Commission observed that careful and deliberate attention should be paid to 

discussions of potential moral objections as the field advances. Such moral 

objections include concerns that synthetic biology may conflict with essential 

conceptions of human agency and life; that its overall impact may be harmful 

to biodiversity, ecosystems, or food and energy supplies; and that it may fail 

to respect the proper relationship between humans and nature. The Commission devoted particular time and attention to discussing these possible moral 

objections during its deliberations. It heard relatively few objections from reli-
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

12

gious or secular ethicists concerning the present status of the field. Although 

the field currently is capable of significant but limited technical achievements, 

potential developments might raise further moral objections—for example, 

applications relying on the synthesis of genomes for higher order or complex 

species. Current objections to synthetic biology on moral grounds are often 

based on concerns regarding activities that the field is currently incapable of 

carrying out. However, continued evaluation and efforts to reach and maintain consensus will be needed as this field develops.

Recommendation 10: Ongoing Evaluation of Objections

Discussions of moral objections to synthetic biology should be revisited periodically as research in the field advances in novel directions. Reassessment of 

concerns regarding the implications of synthetic biology for humans, other 

species, nature, and the environment should track the ongoing development 

of the field. An iterative, deliberative process, as described in Recommendation 14, allows for the careful consideration of moral objections to synthetic 

biology, particularly if fundamental changes occur in the capabilities of this 

science and its applications.

Promoting Intellectual Freedom and Responsibility

The principle of intellectual freedom and responsibility asserts that restrictions 

on research, whether by self-regulation by scientists or by government intervention, should limit the free pursuit of knowledge only when the perceived risk 

is too great to proceed without limit. A moratorium at this time on synthetic 

biology research would inappropriately limit intellectual freedom. Instead, the 

scientific community—in academia, government and the private sector—should 

continue to work together to evaluate and respond to known and potential risks 

of synthetic biology as this science evolves. This effort may require the government to expand current oversight or engagement activities with non-institutional 

researchers. National Institutes of Health or the Department of Energy, for 

example, could be charged to sponsor education programs and workshops that 

bring together these groups. They could fund training grants or related programs 

to promote a culture of responsibility among this community. To exercise the 

appropriate level of oversight, the government will need to monitor the growth 

and capacity of researchers outside of institutional settings. 
executive summary

13

Recommendation 11: Fostering Responsibility and Accountability

The government should support a continued culture of individual and corporate responsibility and self-regulation by the research community, including 

institutional monitoring, enhanced watchfulness, and application of the 

National Institutes of Health Guidelines for Recombinant DNA Research. As 

part of the coordinated approach urged in Recommendation 4, the Executive Office of the President should evaluate, and re-evaluate periodically, 

the effectiveness of current research oversight mechanisms and determine 

what, if any, additional steps should be taken to foster accountability at the 

institutional level without unduly limiting intellectual freedom. Academic 

and private institutions, the public, the National Institutes of Health, and 

other federal funders of synthetic biology research should be engaged in this 

process. An initial assessment should be completed within 18 months and the 

results made public.

The norms of safe and responsible conduct that have evolved over time for many 

researchers in institutional settings may not be understood or followed by those 

new to the field or outside of these settings. It is important to note that presently there appears to be no serious risk of completely novel organisms being 

constructed in non-institutional settings including in the DIY community. 

Scrutiny is required to ensure that DIY scientists have an adequate understanding of necessary constraints to protect public safety and security, but at present 

the Commission sees no need to impose unique limits on this group.

Recommendation 12: Periodic Assessment of Security and Safety Risks

Risks to security and safety can vary depending on the setting in which 

research occurs. Activities in institutional settings, may, though certainly do 

not always, pose lower risks than those in non-institutional settings. At this 

time, the risks posed by synthetic biology activities in both settings appear 

to be appropriately managed. As the field progresses, however, the government should continue to assess specific security and safety risks of synthetic 

biology research activities in both institutional and non-institutional settings 

including, but not limited to, the “do-it-yourself” community. As part of 

the coordinated approach urged in Recommendation 4, the Executive Office 

of the President, working with the Department of Homeland Security, the 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

14

Federal Bureau of Investigation and others, should undertake and periodically update this assessment. An initial review should be completed within 18 

months and the results made public to the extent permitted by law.

Certain risks—generally involving national security—often warrant additional protections. Completely free exchange of data and materials might 

endanger public safety, but unilateral action to limit exchange could damage 

American research efforts in synthetic biology if U.S. scientists and students 

are excluded from full collaboration with the international community. 

Several recent advisory groups have recommended ongoing discussions among 

research universities, industry, and government on this topic. The Commission agrees that scientists should be actively engaged in these debates. 

Recommendation 13: Oversight Controls

If the reviews called for in Recommendation 12 identify significant unmanaged security or safety concerns, the government should consider making 

compliance with certain oversight or reporting measures mandatory for 

all researchers, including those in both institutional and non-institutional 

settings, regardless of funding sources. It may also consider revising the 

Department of Commerce’s export controls. Any such change should 

be undertaken only after consultation with the scientific, academic, and 

research communities and relevant science and regulatory agencies such as 

the National Institutes of Health, the Department of Homeland Security, 

and the Environmental Protection Agency. Export controls should not unduly 

restrain the free exchange of information and materials among members of 

the international scientific community.

Promoting Democratic Deliberation

Through democratic deliberation, questions about synthetic biology can be 

explored and evaluated on an ongoing basis in a manner that welcomes the 

respectful exchange of opposing views. This principle yields several opportunities for government and non-government actors alike to work together to 

ensure that synthetic biology advances in ways that respect divergent views 

and that avoid some of the misunderstanding and confusion, which at times, 
executive summary

15

have hampered other scientific endeavors. To enhance democratic deliberation 

and thereby ensure that the progress in synthetic biology is widely understood 

and policy choices are thoughtfully considered, the Commission makes the 

following recommendations.

Recommendation 14: Scientific, Religious, and Civic Engagement

Scientists, policy makers, and religious, secular, and civil society groups 

are encouraged to maintain an ongoing exchange regarding their views on 

synthetic biology and related emerging technologies, sharing their perspectives with the public and with policy makers. Scientists and policy makers 

in turn should respectfully take into account all perspectives relevant to 

synthetic biology.

Recommendation 15: Information Accuracy

When discussing synthetic biology, individuals and deliberative forums 

should strive to employ clear and accurate language. The use of sensationalist buzzwords and phrases such as “creating life” or “playing God” may 

initially increase attention to the underlying science and its implications for 

society, but ultimately such words impede ongoing understanding of both 

the scientific and ethical issues at the core of public debates on these topics. 

To further promote public education and discourse, a mechanism should be 

created, ideally overseen by a private organization, to fact-check the variety of 

claims relevant to advances in synthetic biology.

This publicly accessible fact-check mechanism is among the most concrete 

ways by which public perception and acceptance of emerging technologies 

could be improved. Education also plays a key role in building public support 

for otherwise unfamiliar technologies. In light of our Nation’s dependence on 

socially responsible scientific innovation for economic progress and individual 

well-being, the urgency of expanding effective science and ethics education 

cannot be exaggerated. Dialogue among individuals and public, private, and 

community groups demonstrates that science and its oversight do not belong 

exclusively to experts, highly trained professionals, or government officials. 

Science is a shared resource, affecting and belonging to all citizens.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

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Recommendation 16: Public Education

Educational activities related to synthetic biology should be expanded and 

directed to diverse populations of students at all levels, civil society organizations, communities, and other groups. These activities are most effective 

when encouraged and supported by various sources, not only government, but 

also private foundations and grassroots scientific and civic organizations. As 

part of the coordinated approach urged in Recommendation 4, the Executive 

Office of the President, with input from the scientific community, the public, 

and relevant private organizations, should identify and widely disseminate 

strategies to promote overall scientific and ethical literacy, particularly as 

related to synthetic biology, among all age groups.

Promoting Justice and Fairness

The principle of justice and fairness, at this very early stage of synthetic 

biology, yields two general recommendations that can be applied to both this 

technology and other emerging technologies. It directs those in government to 

consider rules for distribution of risks and benefits in research, and it directs 

those both in and outside of government to consider processes for just distribution of benefits and risks. 

Recommendation 17: Risks in Research

Risks in research should not be unfairly or unnecessarily borne by certain 

individuals, subgroups, or populations. As part of the coordinated approach 

urged in Recommendation 4, the Executive Office of the President should 

lead an interagency evaluation of current requirements and alternative 

models to identify mechanisms that ensure that the risks of research in synthetic biology, including for human subjects and other affected parties, are 

not unfairly or unnecessarily distributed. Relevant scientific, academic, and 

research communities, including those in the private sector, should be consulted. This review should be completed within 18 months and the results 

made public.
executive summary

17

Recommendation 18: Risks and Benefits in Commercial Production and 

Distribution

Risks to communities and the environment should not be unfairly distributed. Manufacturers and others seeking to use synthetic biology for 

commercial activities should ensure that risks and potential benefits to communities and the environment are assessed and managed so that the most 

serious risks, including long-term impacts, are not unfairly or unnecessarily 

borne by certain individuals, subgroups, or populations. These efforts should 

also aim to ensure that the important advances that may result from this 

research reach those individuals and populations who could most benefit 

from them. As part of the coordinated approach urged in Recommendation 4, 

the Executive Office of the President should evaluate current statutory mandates or regulatory requirements for distribution of risks and benefits and 

consider developing guidance materials and voluntary recommendations to 

assist manufacturers as appropriate.

In summary, the ability to easily manufacture and manipulate DNA in 

the laboratory has enhanced scientists’ productivity and opened new directions for scientific exploration. In the future, scientists may be able to create 

entirely new organisms and systems previously unknown in the world today. 

But breakthroughs such as this raise a host of complex and sometimes controversial issues. They can help humanity in many ways, but they invariably 

carry some risks and often raise public concerns and fears. With these unprecedented achievements comes an obligation to consider carefully both the 

promise and potential perils that they could realize. 

The recommendations detailed in this report provide a publicly accountable 

basis for ensuring that the field of synthetic biology advances to improve 

human health and public welfare with processes in place to identify, assess, 

monitor, and mitigate risks on an ongoing basis as the field matures. Risk 

assessment should precede field release of the products of synthetic biology. 

Ongoing assessment and review is required in several areas to avoid 

unnecessary limits on science and social progress, and to ensure appropriate 

restrictions to protect individual safety and our shared environment. Ongoing 

dialogue about concerns regarding the implications of synthetic biology for 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

18

humans, other species, nature, and the environment should continue as 

synthetic biology develops from its infancy to a fully mature field of scientific 

inquiry and innovation.
19

chapter 1

Introduction 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

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On May 20, 2010, the J. Craig Venter Institute announced it had created 

the world’s first self-replicating synthetic genome in a bacterial cell of 

a different species.1

 Although scientists have used recombinant DNA techniques to engineer pieces of the genetic code for many years, this achievement 

marked the first time that all of the natural genetic material in a bacterial cell 

was replaced with a synthetic (i.e., human made or chemically synthesized) 

copy of the genes necessary for that organism to function. This announcement 

made headlines around the globe. Reaction was immediate, and it spanned 

the spectrum from expressions of enthusiasm to cries of alarm. Thoughtful 

deliberation about the meaning of this achievement was impossible in the 

hours that elapsed between the breaking news and the initial round of commentaries that ensued.

There is general agreement that this first self-replicating synthetic genome 

is an exceptional achievement, but there is also vigorous debate about just 

how momentous the Venter Institute’s success is. Some scientists consider it a 

quantum leap; others see it as an incremental stride.2

 Whether one considers 

the accomplishment a major advance, a more modest technical step, or some 

combination of the two, one cannot deny the importance of understanding 

the potential implications of this and related accomplishments for humankind. The ability to synthesize vaccines, drugs, biofuels, and crops could do 

much to advance human welfare. At the same time, these innovations raise 

concerns about what we do not know—that is, whether there are attendant 

human or environmental risks—and what we perhaps should not know, that 

is, how to engineer forms of “life” to serve our own purposes. 

Rather than offer an immediate opinion on the possible ethical and public 

policy implications—both positive and negative—of this scientific and 

technical accomplishment, President Barack Obama asked the Presidential 

Commission for the Study of Bioethical Issues (the Commission) as its first 

order of business to recommend how the developing field of synthetic biology 

and related biotechnologies can best maximize public benefits, minimize 

risks, and observe appropriate ethical boundaries.3 He turned to the Commission to conduct “a study of the implications of this scientific milestone, 

as well as other advances that may lie ahead in this field of research.” It was 

directed to consider the “potential medical, environmental, security, and other 
Introduction I

21

benefits of this field of research, as well as any potential health, security, or 

other risks.” The President charged the Commission to provide recommendations within six months on “any actions the federal government should take to 

ensure that America reaps the benefits of this developing field of science while 

identifying appropriate ethical boundaries and minimizing identified risks.” 

Much stands to be gained by the government taking a deliberative and open 

approach to decision making in this and many other complex scientific and 

technical areas of public importance.

Recent advances in biotechnology have transformed the life sciences, yielding 

a level of innovation rarely witnessed in human history. These achievements 

raise a host of complex and often controversial issues. Breakthroughs can help 

humankind in many ways, but they invariably carry some risks. Discoveries of 

new ways of improving or enhancing life raise public hopes and expectations, 

but they also raise public concerns and, often, fears. Proponents of synthetic 

biology cite its potential to reduce our reliance on fossil fuels and transform 

medical care and human health, among other possible benefits. Critics express 

concerns about “playing God,” threatening biodiversity and the organization 

and natural history of species, demeaning and disrespecting the meaning of 

life, and threatening longstanding concepts of nature. With these unprecedented opportunities and achievements comes an obligation to consider 

carefully both the promise and potential perils that they could realize. 

Airing these expectations and concerns in a public forum maximizes the 

potential for public benefit and illuminates risks and possible harms—

physical, environmental, and social—that deserve our attention and careful 

consideration. In addressing the President’s charge the Commission therefore 

attempted to be an inclusive and deliberative body, encouraging the exchange 

of well-reasoned perspectives with the goal of making recommendations 

that will serve the public well and will advance the public good. It gathered specific information about the state of synthetic biology, reviewed the 

findings and recommendations of numerous U.S. and international groups, 

and listened to sometimes conflicting scientific, ethical, and social perspectives. It sought common ground where possible and generally found it. When 

common ground was impossible to find, the Commission cultivated mutual 

respect through active engagement with differing views.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

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The Commission’s Process

In conducting its work, the Commission invited experts and representatives of 

the public to explore contested territory from multiple perspectives. Some guests 

presented information about recent and upcoming achievements in the science 

of synthetic biology, including current and future applications and benefits. 

Others shared their perspectives on anticipated risks, related regulatory and 

oversight issues, and ethical considerations. The Commission solicited questions 

from the public as well as from its own members. This format contributed to 

highly interactive and valuable sessions. In addition, the Commission encouraged the public to provide written comments throughout its deliberations, and 

nearly 40 individuals and groups submitted comments. It also consulted with 

relevant federal agencies and private entities considering similar questions. 

Formal deliberations began with an overview of potential benefits. Without 

any realistic promise of benefits, no risks would be worth taking. Expert panelists cited a host of potential benefits including more efficient and effective 

drug development; accelerated synthesis of vaccines in response to pandemics; and the ability to engineer algae and other microbes to spur advances 

in clean-burning fuel, agriculture, bioremediation, and medicine. The Commission also heard about the promise of a robust bio-economy beginning to 

materialize in the form of novel technological platforms. These and other 

areas of research in synthetic biology offer significant opportunities for economic growth and job creation.

After discussing the possible benefits of synthetic biology, the Commission 

considered the current and foreseeable risks posed by this rapidly evolving 

field. Although the risks at this early stage in the field’s development are well 

managed and relatively small in comparison to the anticipated benefits of the 

field, they do exist, and several themes emerged in Commission discussions.

First, sheer prudence suggests that we as a society must respect the intricacies 

of the natural world. Biological systems have developed over billions of years, 

and their interactions with the environment are astoundingly complex. We 

are far from being proficient speakers of the language of life, and our capacity 
Introduction I

23

to control synthetic organisms that we design and release into the world is 

promising but unproven.

Second, understanding our own limitations is an essential prelude to minimizing the risks that will accompany ongoing breakthroughs in synthetic 

biology and related fields. Like other new technologies, synthetic biology 

poses uncertain risks. Rapidity of change, both in the field of biology and in 

the public’s understanding of it, as well as accelerating information exchange 

and technological competence heighten these concerns. Today, predicting cell 

function from gene sequence alone is very difficult and often impossible.4

While the successful synthesis of a functional bacterial chromosome is an 

essential technological step for the development of synthetic biology, it represents a preliminary advance. We remain far from having the scientific and 

technical expertise required to create truly novel functioning organisms. We 

must be cognizant, however, of our limited current understanding of what 

synthetic biology and related technologies may produce in the future and be 

willing to reassess benefits and harms as the field develops. 

Third, ancillary effects and challenges should be recognized and considered. 

The rise of an economy based on biotechnology may expand jobs and lead 

to significant financial benefits, but it could also result in economic displacement, excessive demands on already scarce resources, and increased social and 

economic stratification. Anticipating all of the ramifications of our actions is 

impossible, but determining how to respond to this uncertainty is the better part 

of wisdom. The Commission also considered related questions regarding how the 

U.S. government can best respect intellectual freedom in scientific inquiry and 

nurture the development of synthetic biology in a way that maximizes its potential benefits while reducing the risks and likelihood of direct and indirect harms. 

Critical to all of these themes is the importance of earning public trust in the 

integrity of both the scientific and engineering communities and the applicable regulatory systems. The Commission therefore focused on the need for 

greater public education and engagement on these issues as a prerequisite for 

public acceptance of this new technology and assurance of constructive criticism moving forward.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

24

Basic Ethical Principles for Assessing Emerging Technologies

In approaching its task, the Commission was mindful of the need for an ethical 

framework for considering the implications of new and emerging technologies 

like synthetic biology, which itself represents one step in a long continuum of 

scientific innovation.5

 This is a unique opportunity to consider the ethics of an 

emerging technology at a very early stage of its development.6

 The Commission found many efforts to shape policy, governance, and regulation related to 

synthetic biology, but few examples of an ethical framework upon which to 

gird such proposals. Accordingly, in weighing alternative policy preferences and 

perspectives, it identified five ethical principles relevant to considering the social 

implications of synthetic biology as well as all emerging technologies. These 

principles provide a useful vehicle through which to evaluate the current state 

of the field and formulate the Commission’s recommendations.

The guiding principles are: (1) public beneficence, (2) responsible stewardship, 

(3) intellectual freedom and responsibility, (4) democratic deliberation, and 

(5) justice and fairness. These principles should be understood as provisional 

guideposts. The Commission encourages others to subject these principles, 

and the recommendations based on them, to further refinements and revisions, as it has done and will continue to do in the future. 

Public Beneficence

The ideal of public beneficence is to act to maximize public benefits and 

minimize public harm. The principle encompasses the duty of a society and 

its government to promote individual activities and institutional practices, 

including scientific and biomedical research, that have great potential to 

improve the public’s well-being. In the case of emerging technologies like 

synthetic biology, this improvement may be by means of providing improved 

or more widely available forms of medical and health care, food, shelter, 

transportation, clothing, and eco-friendly fuel, along with other means of 

improving people’s lives. Scientific and technological discovery often have the 

added potential of increasing economic opportunities, which also redound to 

the public good.
Introduction I

25

The Belmont Report, a landmark statement of ethical principles for research 

involving human subjects, defined beneficence to require that “[p]ersons 

are treated in an ethical manner not only by respecting their decisions and 

protecting them from harm, but also by making efforts to secure their wellbeing.”7

 Two general rules stem from this principle: first, do no harm; and 

second, maximize possible benefits and minimize possible harms. 

For synthetic biology and other emerging technologies, we need to apply the 

principle of beneficence beyond the individual level, the primary emphasis of 

the Belmont Report, to the institutional, community, and public levels, while 

not overlooking possible harms and benefits to individuals. Policy makers 

should adopt a societal perspective when deciding whether to pursue particular benefits of synthetic biology research in the face of risks and uncertainty. 

When deciding whether to restrict these pursuits, a similar consideration of 

community interests and potential positive and negative impacts is essential. 

Public beneficence requires that when seeking the benefits of synthetic 

biology, the public and its representatives be vigilant about risks and harms, 

standing ready to revise policies that pursue potential benefits with insufficient 

caution. The Commission explores the concomitant challenges of meaningful 

and valuable risk-benefit analysis and potential strategies to address them in 

the “Responsible Stewardship” section, below.

Responsible Stewardship

Among living beings, humans are in a unique position to be responsible stewards of nature, the earth’s bounty, and the world’s safety. Human society and 

governments have a duty to proceed prudently in promoting science and technologies, many of which can improve human welfare but also can harm the 

environment, create security risks, or otherwise lead to adverse consequences 

for vulnerable populations or future generations. The principle of responsible 

stewardship reflects a shared obligation among members of the domestic and 

global communities to act in ways that demonstrate concern for those who are 

not in a position to represent themselves (e.g., children and future generations) 

and for the environment in which future generations will flourish or suffer. 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

26

Scientists, policy makers, and the public are tasked with appreciating that the 

tools of science and technology possess both remarkable potential to enhance 

future lives and a spectrum of risks capable of causing harm. Both demand 

attention and action.

Responsible stewardship recognizes the importance of citizens and their representatives thinking and acting collectively for the betterment of all, especially 

those who cannot represent themselves. These activities must respect the significant impact—both positive and negative—that our decisions have on our 

world, both today and in the future. 

Benefits and risks extend to humans, nonhuman species, and the environment, each with unique needs and vulnerabilities. Emerging technologies 

present particularly profound challenges for responsible stewardship because 

our understanding of these potential benefits and risks is largely incomplete, 

preliminary, and uncertain. The prospect of intentional misuse by malicious 

actors further complicates efforts to respond adequately to the spectrum of 

benefits and risks.

Responsible stewardship addresses these varied challenges by calling for 

actions that embrace potential benefits while mitigating risks over time and 

across all populations. It calls for broader risk-benefit discussions than what 

would typically be required based on a concern for public beneficence alone. 

The principle of responsible stewardship rejects two extreme approaches: an 

extreme action-oriented approach that pursues technological progress without 

limits or due regard for public or environmental safety, and an extreme precautionary approach that blocks technological progress until all possible risks 

are known and neutralized. While the action-oriented approach is irresponsibly brazen, the precautionary approach is overly wary. Both fail to carefully 

assess the most likely and significant benefits against the most likely and 

significant harms. Through the development of agile, measured oversight 

mechanisms, responsible stewardship rejects positions that forsake potential 

benefits in deference to absolute caution and those that ignore reasonably 

foreseeable risks to allow unfettered scientific exploration. 
Introduction I

27

This principle is applied to synthetic biology and other emerging technologies through open decision-making processes informed by the best available 

science. Responsible stewardship calls for prudent vigilance, establishing processes for assessing likely benefits along with safety and security risks both 

before and after projects are undertaken. A responsible process will continue 

to evaluate safety and security as technologies develop and diffuse into public 

and private sectors. It will also include mechanisms for limiting their use 

when indicated. 

Prudent vigilance does not demand extreme aversion to all risks. Not all 

safety and security questions can be definitively answered before projects 

begin, but prudent vigilance does call for ongoing evaluation of risks along 

with benefits. The iterative nature of this review is a key feature of responsible 

stewardship. It recognizes that future developments demand that decisions be 

revisited and amended as warranted by additional information about risks and 

potential benefits. The duty to be responsible stewards of nature, the earth’s 

bounty, and the world’s safety rests on concern not only for human health 

and well-being today but also, and importantly, for future generations and the 

environment looking forward. 

Intellectual Freedom and Responsibility

Democracies depend on intellectual freedom coupled with the responsibility of individuals and institutions to use their creative potential in morally 

responsible ways. Sustained and dedicated creative intellectual exploration 

begets much of our scientific and technological progress. Without the free 

marketplace of ideas we would not have many of the scientific discoveries 

and advancements that have aided us in harnessing energy, sustaining life, 

and raising our collective standard of living. Intellectual freedom, therefore, 

is critical for developing innovative technologies that can compete in the 

global marketplace, and it is a necessary condition for industrial and academic 

collaborations that yield useful products and tools. While many emerging 

technologies raise concerns about their potential malevolent use, these risks 

alone are generally insufficient to justify limits on intellectual freedom. If we 

as a society stifle intellectual freedom for fear of enabling harm, we will be 

unprepared and vulnerable if that harm is unleashed upon us. A robust public 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

28

policy regarding the responsible conduct of science must promote the creative 

spirit of scientists and unambiguously protect their intellectual freedom. 

At the same time, responsible science should reject the technological imperative: the mere fact that something new can be done does not mean that 

it ought to be done. The history of science here and abroad is sadly full 

of examples of intellectual freedom exercised without responsibility that 

resulted in appalling affronts to vulnerable populations, the environment, 

and the ideals of the profession of science itself. Scientists who act irresponsibly are capable not only of harming themselves and other individuals, but 

also of harming their communities, their nations, and international relations. 

Society as a whole has a stake in what scientists and engineers do, and they 

must not operate as if their research is totally independent of the groups who 

will experience both the benefits and burdens of their work. Risks may be 

especially great when those who provide the means and those who experience 

benefits are not the same. It is society that collectively provides the means for 

scientists to do their work and it is to society collectively that scientists bear 

profound responsibility. 

As a corollary to the principle of intellectual freedom and responsibility, 

the Commission endorses a principle of regulatory parsimony, recommending only as much oversight as is truly necessary to ensure justice, fairness, 

security, and safety while pursuing the public good. Regulatory parsimony is 

particularly important in emerging technologies, which by their very definition are still in formation and are not always well-suited for sharply specified 

limitations. The blunt instruments of statutory and regulatory restraint may 

not only inhibit the distribution of new benefits, but they can be counterproductive to security and safety by preventing researchers from developing 

effective safeguards.8

 With sufficient freedom to operate, tomorrow’s achievements may render moot the risks of today. Self-regulation also promotes a 

moral sense of ownership within a professional culture of responsibility. 

Democratic Deliberation

The principle of democratic deliberation reflects an approach to collaborative 

decision making that embraces respectful debate of opposing views and active 
Introduction I

29

participation by citizens. It calls for individuals and their representatives to 

work toward agreement whenever possible and to maintain mutual respect 

when it is not.9

At the core of democratic deliberation is an ongoing, public exchange of 

ideas, particularly regarding the many topics—in science and elsewhere—in 

which competing views are advocated, often passionately. Through formal and 

informal deliberative processes, decision makers and the people they represent 

should strive for mutually acceptable reasons to justify the policies that they 

adopt. These justifications should be expressed in ways that are accessible to 

those to whom such policies apply. 

Citizens, individually and collectively, are active participants in democratic 

deliberation, engaging in dialogues both among themselves and with their 

representatives charged with developing policy. Public discussion and debate 

promote the legitimacy of whatever outcomes are reached, even if those 

outcomes are unlikely to please all interested parties. A process of active 

deliberation and justification promotes an atmosphere for debate and decision making that looks for common ground wherever possible and seeks to 

cultivate mutual respect where irreconcilable differences remain. It encourages 

participants to adopt a societal perspective over individual interests.

Importantly, democratic deliberation recognizes that while decisions must 

eventually be reached, those decisions need not (and often should not) be 

permanent, particularly when subsequent developments warrant additional 

examination. Democratic deliberation can correct the inevitable mistakes that 

arise when decisions are made collectively, provided that it is an ongoing, 

dynamic process. It recognizes the importance of challenging previously 

reached conclusions in light of new information or perspectives. It therefore 

requires citizens to take seriously the possibility that the views of one’s opponents may be shown to be correct in the future and to be open to changing 

their own views. 

With careful attention to the processes through which decisions are reached 

and justified, democratic deliberation promotes outcomes that are inclusive, 

thoughtfully considered, and respectful of competing views.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

30

The principle of democratic deliberation, although a less familiar principle 

in bioethics than the principles of beneficence and justice, is particularly 

well-suited to the assessment of emerging technologies, including synthetic 

biology.10 These fields offer the promise of remarkable potential benefits 

to science and society, yet they also raise risks regarding unintended consequences or possible malicious use. Each of these areas is clouded by 

uncertainty, complicating efforts to promote innovation while minimizing 

the likelihood of harm. Finding this balance demands careful ongoing review 

of the science and its applications. It presents an ideal opportunity for broad 

engagement and dialogue among the scientific community, policy makers, 

and the public. This active public engagement can enhance the decisions 

that are reached and the overall public understanding of them, as well as the 

related issues in science and technology that are central to the future of this 

new technology, as well as to our Nation and the world.

Justice and Fairness

The principle of justice and fairness relates to the distribution of benefits and 

burdens across society. Emerging technologies like synthetic biology, for good 

or ill, affect all persons. Society as a whole has a claim toward reasonable 

efforts on the part of both individuals and institutions to avoid unjust distributions of the benefits, burdens, and risks that such technologies bring. This 

same claim extends internationally to all those who may be affected—positively or negatively—by synthetic biology and its applications. As much as 

possible, and consistent with establishing essential incentives for creating new 

knowledge and translating it into vibrant markets, a fundamental principle 

of fairness suggests that society should seek to ensure that the benefits and 

burdens of new technologies are shared.

A commitment to justice and fairness is a commitment to seek to ensure that individuals and groups receive that to which they are entitled, that is, what they can 

reasonably and legitimately expect. Identifying, anticipating, and assessing what 

is reasonable to expect and determining how to measure and compare potential 

risks and benefits are complex activities, even in the best of circumstances and 

with the most complete data. They are made more difficult by the uncertainties 

surrounding scientific advances and the emergence of new technologies. How, for 
Introduction I

31

example, are we to measure and compare the benefits of a technological innovation that leads to an effective medical treatment available on an unprecedented 

scale at low cost against the costs imposed by the disruption and displacement of 

previously existing technologies and the people whose livelihoods depends upon 

them? Advances produced through biotechnology can be highly beneficial but 

costly. How can and should we ensure that such advances reach those who could 

benefit most rather than being available only to those who can afford to pay? 

While such questions are difficult to answer, society must work to provide answers 

that are both just and fair. 

The principle of justice and fairness also suggests that society should seek to 

ensure that the unavoidable burdens of technological advances do not fall 

disproportionately on any particular individual or group. Technological innovation benefits from public investment and from societal contribution toward 

safe and supportive research environments, and so it is reasonable that society 

expect a return on that investment.

Justice and fairness extend not only from individual societies to their constituents but also from individual societies to the international community overall. 

Emerging technologies like synthetic biology can and likely will have global 

impacts. For that reason, every nation has a responsibility to champion fair 

and just systems to promote the widest availability of information, the broadest distribution of beneficial technologies, and the most expansive culture of 

responsibility for biosafety and biosecurity. 

About This Report

With these guiding principles in mind, the Commission considered the array 

of ethical public policy issues surrounding the field of synthetic biology. It 

reviews the science and potential benefits of this field in Chapters 2 and 3. 

Chapter 4 summarizes the existing oversight framework for new and emerging technologies like synthetic biology. Chapter 5 examines the implications 

of synthetic biology as viewed through the five principles described above 

and offers recommendations to ensure that society reaps the benefits of this 

developing field of science while identifying appropriate ethical boundaries 

and minimizing identified risks. 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

32

1 Gibson, D.G., et al. (2010). Creation of a bacterial cell controlled by a chemically synthesized 

genome. Science 329(5987):52-56.

2 See, e.g., Endy, D., Terman Fellow and Assistant Professor of Bioengineering, Stanford 

University. (2010). Overview and Context of the Science and Technology of Synthetic 

Biology. Presentation to the Presidential Commission for the Study of Bioethical Issues, July 

8, 2010. Available at: http://bioethics.gov/transcripts/synthetic-biology/070810/overview-andcontext-of-the-science-and-technology.html; Prather, K., Assistant Professor, Department 

of Chemical Engineering, Massachusetts Institute of Technology. (2010). Applications of 

Synthetic Biology. Presentation to the Presidential Commission for the Study of Bioethical 

Issues, July 8, 2010. Available at: http://bioethics.gov/transcripts/synthetic-biology/070810/

applications-of-synthetic-biology.html; Petsko, G.A. (2010). Hand-made biology. Genome 

Biology 11:124.

3

 Letter from President Barack Obama to Dr. Amy Gutmann, Chair, Presidential Commission 

for the Study of Bioethical Issues, May 20, 2010. Available at: http://bioethics.gov/

documents/Letter-from-President-Obama-05.20.10.pdf.

4 National Academies, Board on Life Sciences. (2010). Sequence-Based Classification of Select 

Agents: A Brighter Line. Washington, D.C.: National Academies Press; National Science 

Advisory Board for Biosecurity. (2010). Addressing Biosecurity Concerns Related to Synthetic 

Biology. Available at: http://oba.od.nih.gov/biosecurity/biosecurity_documents.html.

5 The Belmont Report, issued in 1979 by the National Commission for the Protection of 

Human Subjects of Biomedical and Behavioral Research, was pathbreaking in the field of 

bioethics. It articulated and applied a three-pronged ethical framework: respect for persons, 

beneficence, and justice. These principles have become a widely used tool through which to 

assess questions in human subjects research and related topics. However, the Belmont Report’s

principles demand refinement in light of new knowledge, different circumstances, and 

changing experiences. By proactively reflecting on and applying the ethical principles most 

relevant to our actions, we pursue a practical wisdom—knowledge that aims to produce the 

best results for society and the world. 

6 The Commission contrasts its work in this respect with that of the National Bioethics 

Advisory Commission, which was asked by President William Clinton to review ethical 

issues related to reproductive cloning after the successful cloning of an adult sheep. See

National Bioethics Advisory Commission (1997). Cloning Human Beings. Available at: 

http://bioethics.georgetown.edu/pcbe/reports/past_commissions/nbac_cloning.pdf.

7 National Commission for the Protection of Human Subjects of Biomedical and Behavioral 

Research. (1979). The Belmont Report: Ethical Principles and Guidelines for the Protection 

of Human Subjects of Research. Available at: http://www.hhs.gov/ohrp/humansubjects/

guidance/belmont.htm.
Introduction I

33

8

 For example, the “Variola Amendment” to the Intelligence Reform and Terrorism Prevention 

Act of 2004 made it criminal to produce, engineer, or synthesize the variola virus. The 

“variola virus” was in turn defined to include “any derivative of the variola major virus that 

contains more than 85 percent of the gene sequence of the variola major virus or the variola 

minor virus.” 18 U.S.C. § 175c. The broad definition of “variola virus” made it unclear what 

was actually covered by the statute, and a strict interpretation of the definition would have 

potentially, and inadvertently, criminalized beneficial research such as production of the 

smallpox vaccine.

9 Gutmann, A., and D. Thompson. (1996). Democracy and Disagreement. Cambridge, 

Mass.: Belknap Press; Gutmann, A., and D. Thompson. (1997). Deliberating about 

bioethics. The Hastings Center Report (May/June):38-41; Gutmann, A., and D. Thompson. 

(2000). Why deliberative democracy is different. Social Philosophy and Policy 17:161-180; 

Gutmann, A., and D. Thompson. (2002). Just deliberation about health care. In Ethical 

Dimensions of Health Policy. M. Danis, C. Clancy, and L. Churchill (eds.). Oxford: 

Oxford University Press.

10 Daniels, N. (2008). Just Health: Meeting Health Needs Fairly. Cambridge: Cambridge 

University Press, 103-139; Fleck, L. (2009). Just Caring: Health Care Rationing and 

Democratic Deliberation. Oxford: Oxford University Press.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

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35

chapter 2

Science of Synthetic Biology 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

36

Synthetic biology is the name given to an emerging field of research that 

combines elements of biology, engineering, genetics, chemistry, and computer science. The diverse but related endeavors that fall under its umbrella 

rely on chemically synthesized DNA, along with standardized and automatable processes, to create new biochemical systems or organisms with novel 

or enhanced characteristics. Whereas standard biology treats the structure 

and chemistry of living things as natural phenomena to be understood and 

explained, synthetic biology treats biochemical processes, molecules, and structures as raw materials and tools to be used in novel and potentially useful 

ways, often quite independent of their natural roles. It joins the knowledge 

and techniques of biology with the practical principles and techniques of engineering. “Bottom-up” synthetic biologists, those in the very earliest stages 

of research, seek to create novel biochemical systems and organisms from 

scratch, using nothing but chemical reagents. “Top-down” synthetic biologists, who have been working for several decades, treat existing organisms, 

genes, enzymes, and other biological materials as parts or tools to be reconfigured for purposes chosen by the investigator. 

For the purposes of this report, the Commission focused on the molecular 

and cellular engineering techniques of synthetic biology and the most foreseeable benefits of this very early field. In time, synthetic biology products for 

clean energy, pollution control, agriculture, and medicine, may change our 

lives and our shared environment through the development of novel applications. Because the potential applications of synthetic biology are speculative at 

this time, and the field is advancing in exciting directions, it is inviting both 

optimism and unease among scientists and the public.

From Molecular Biology to Synthetic Biology

Synthetic biology is deeply rooted in molecular biology, a field that emerged 

decades ago with the discovery of the structure and composition of DNA. 

DNA molecules provide the instructions that direct cell growth, development, and differentiation in every living organism. They contain a sequence 

of four types of chemical building blocks—adenosine, thymine, cytosine, and 

guanine (A, T, C, and G)—that combine, ladder-like and in various order, 

into “base pairs” that are combined into sets called “genes” (see Figure 1).
SCIENCE OF SYNTHETIC BIOLOGY II

37

Individual gene sequences code for particular proteins, which are what 

enable cells to function. Collectively, the complete DNA sequence of an 

organism is called its “genome.” Genome variation is what makes individual 

organisms unique.

Base pairs are combined 

into sets called genes

Individual gene sequences code for unique proteins

Proteins work together to enable cells to function

DNA (Deoxyribonucleic acid)

Gene Gene Gene

Chromosome

Genome

Cell

A

T

T C G T

A G C A

Base pair

Sugar-phosphate backbone

Figure 1: DNA, genes, and proteins.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

38

Though not described as such at the time, the earliest achievements in what 

is today called synthetic biology can be traced to the birth of genetic engineering in the 1970s. Genetic engineering, sometimes called gene-splicing or 

recombinant DNA research, is the intentional manipulation of an organism’s 

genetic material using tools that cut, move, and reattach (recombine) DNA 

segments within and across different organisms. 

In 1972, Stanford University biochemist Dr. Paul Berg created the first 

recombinant DNA molecules by splicing DNA from a bacterial virus into that 

of a monkey virus, SV40.1

 Two years later, scientists created the first transgenic mammal by introducing foreign DNA into mouse embryos.2

 Today, 

transgenic mice are a staple of biomedical research. They are used to regulate 

the expression of individual genes in order to understand how those genes 

interact with the environment and, in turn, affect human health. Using transgenic mice also enables researchers to increase or decrease specific proteins 

and better understand their individual roles and functions.3

As recombinant DNA technology began to develop in the 1970s, individual 

scientists, policy makers, and nations undertook profound debate about the 

safety and permissibility of this research—whether it was too dangerous to 

proceed at all—in the face of deep uncertainty.4 Like synthetic biology today, 

great promise and potential risks were identified.5

 Expert and lay groups 

intensely debated concerns about possible adverse human health and environmental effects. 

In 1974, a group of American scientists called for a moratorium on DNA 

research and the scientific community voluntarily obliged. To resolve this 

stalemate, in 1975 scientists from around the world, policy makers, lawyers, 

and press met together at the Asilomar Conference Center in Pacific Grove, 

California, to debate safety issues. The deliberations at the Asilomar Conference on Recombinant DNA led to formation of guidelines to ensure safety 

and a scientific peer review group, today known as the Recombinant DNA 

Advisory Committee of the National Institutes of Health (NIH). Both the 

guidelines and the Recombinant DNA Advisory Committee remain as critical 

components of the genetic engineering research oversight system (see Chapter 

4 for further discussion). Many of the processes first proposed at the Asilomar 
SCIENCE OF SYNTHETIC BIOLOGY II

39

Conference remain in place, though some have changed in the intervening 

years as understanding of risks has improved. Scientists and policy makers 

have pointed to Asilomar as valuable precedent when considering debates 

regarding research in synthetic biology.

By the end of the 1970s, scientists had created the first commercial product 

of genetic engineering. An extraordinary benefit for human health, human 

insulin produced using recombinant DNA technology transformed treatment 

for diabetes.6 Following its entrance to the market, public acceptance of this 

new technology grew and fears decreased significantly.7

In the early 1980s, researchers developed another revolutionary technique, 

called polymerase chain reaction (PCR). The PCR method enabled researchers to amplify and make simple changes to DNA pieces. PCR acts like a 

molecular copy machine, allowing scientists to enlarge individual DNA sections and manipulate them more easily.

By the early 1990s, automated DNA sequencing became available. This 

technology considerably accelerated the process of determining the order of 

individual gene segments, called “nucleotides,” or, when very small (typically less than 20 base pairs), “oligonucleotides.” Through large-scale genome 

sequencing efforts, primarily the public and private Human Genome Project, 

scientists were able identify the complete genetic codes of numerous naturally 

occurring organisms, including bacteria, viruses, and higher organisms such 

as mice and humans. The genome of a bacterial cell typically includes 5 to 

10 million base pairs, although the synthesized genome of the bacteria in 

the J. Craig Venter Institute research, described below, contained just over 1 

million base pairs.8

 By comparison, a fruit fly genome includes 165 million 

base pairs, and the human genome includes more than 3 billion base pairs. 

These significant differences in scale help place the achievement of the Venter 

Institute team in context. While it represents the first successful synthesis of 

a complete genome of a single-celled bacterium, it is a relatively small genome 

compared to those of other species.

After scientists could sequence naturally occurring DNA, they developed 

techniques to synthesize, or chemically construct, DNA and pieces of DNA.9 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

40

Figure 2 shows an early DNA synthesis machine and the individual chemicals, including nucleic acids, used to construct sequences. Within the last few 

years, researchers have developed methods to accurately synthesize increasingly longer segments of DNA and to bring them together into even larger 

segments of DNA. Stemming from this research, a small industry of commercial DNA synthesis providers has emerged. Five of the main companies, 

roughly 80 percent of the market, are based in the United States.10

Figure 2: Early DNA synthesis machine. (Courtesy of Life Technologies)
SCIENCE OF SYNTHETIC BIOLOGY II

41

The development of DNA synthesis technology has enabled scientists to make 

entire genes, and, eventually, the complete genome of a microorganism using 

synthetic methods alone. By synthesizing a complete genome for a bacterial cell and transferring it to a cell with its own genome that was later lost, 

researchers at the Venter Institute created a self-replicating bacterial cell with 

entirely chemically constructed DNA (see Figure 3).11

Figure 3: The assembly of a synthetic M. mycoides genome in yeast. Source: Gibson, D.G., et al. (2010). 

Creation of a bacterial cell controlled by a chemically synthesized genome. Science 329(5987):52-56.

Asc I

Elements for yeast propagation

and genome transplantation

Oligonucleotide

synthesizer

Oligonucleotides

1,080 bp cassettes (1,078)

(Assemble 109X)

10,080 bp assemblies (109)

(Assemble 11X)

100,000 bp assemblies (11)

(Assemble 1X)

1,077,947 bp

800,000 Yeast

1,077,947

200,000

400,000

600,000

1

WM4

WM3

BssH II

BssH II

94D

BssH II

BssH II

BssH II

BssH II

Asc I

Asc I

WM2

WM1

811-900

901-1000

1001-1104

2-100

101 2- 00

003- 102

03 - 1 04 0

401-500

501-600

601-700

701-799
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

42

Of note, many scientists observe that this achievement is not tantamount to 

“creating life” in a scientific sense because the research required a functioning, 

naturally occurring host cell to accept the synthesized genome. At the same 

time, this development should not be undersold. For many, this work represents the “proof of principle” that synthetic biology techniques can be used to 

construct cells and other organisms with novel characteristics.12 While this 

small step does not give us the ability to grow larger-scale organisms, human 

tissue, or other tools of regenerative medicine, it is an incremental step on 

which future technical and scientific achievements will build.

Early molecular biology laid the groundwork for today’s synthetic biology, but 

more recent technological advances have accelerated its development. First, 

scientists have developed the ability to mechanically synthesize increasingly 

longer DNA segments accurately and more rapidly than had been possible 

previously. Second, the costs for DNA synthesis have fallen dramatically over 

the past decade, dropping from about $30 to well under $1 per base pair.13

The First Self-Replicating Synthetic Bacterial Cell

A May 21, 2010 publication in the journal Science by researchers from the Venter 

Institute announced the design, synthesis, and assembly of the 1.08 million base 

pair chromosome of a modified Mycoplasma mycoides bacterial genome. Beginning 

with an accurate, digitized genome of the bacteria, the researchers added four watermark sequences to identify the genome more clearly. They then designed more 

than 1,000 cassettes of DNA including approximately 1,080 base pairs each, with 80 

base pair overlaps on each cassette representing adjacent sequences. The fragments 

were assembled sequentially in yeast. First, 10 cassettes each combined to make 

10,000 base pair intermediates. Ten of those intermediates next were assembled to 

produce eleven 100,000 base pair intermediates, which were then combined into 

the complete genome. The newly synthesized genome was initially grown in yeast 

before being isolated and transplanted into cells of another bacterium, Mycoplasma 

capricolum. The genome of the recipient cells were lost as the cells were incubated, 

resulting in viable, self-replicating Mycoplasma mycoides cells containing only DNA 

from the synthetic genome.
SCIENCE OF SYNTHETIC BIOLOGY II

43

Computer modeling, not readily available until recently, is also facilitating the 

design of novel genetically engineered biological systems. As with electrical or 

civil engineering, modeling is intended to help scientists predict the behavior 

of a system before it is actually built. Although biological systems are not 

nearly as easily modeled as an electronic circuit or a bridge, at least at this 

time, sophisticated simulations, mostly in single-cell systems, are contributing 

to improved computer modeling of synthetic biological systems. 

Synthetic Biology Techniques and Strategies

As discussed previously, to date synthetic biology has been characterized 

by top-down and bottom-up approaches.14 The techniques overlap to some 

extent, and both approaches share a common goal: to engineer specific 

biological functions with predictability and reliability. In the future, these 

approaches may come together. For now, it is useful to consider both as illustrative of different experimental methods to reach the same goal.

Top-Down Approach

Through the top-down approach, in use since the 1970s, scientists use synthetic biology to re-design existing organisms or gene sequences with the goal 

of stripping out unnecessary parts, or replacing or adding specific parts to 

achieve new or amplified characteristics and functions (see Figure 4). Using 

this approach, scientists aim to remove parts of an organism or genetic code to 

create what some have dubbed a “chassis organism” that can then be modified 

through the addition or subtraction of engineered genetic circuits or metabolic pathways.15

One recent example of the top-down approach in synthetic biology is the 

identification of a “minimal genome.”16 This research provided proof of principle that the total genetic material of a small bacterium, its genome, could be 

pared down into a functioning unit consisting of only a subset of the organism’s original genes.

Top-down synthetic biology is also defined by borrowing properties from one 

or more living systems to create something new. One example is combining 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

44

the productivity of yeast cells with the metabolic flexibility of bacteria. In 

this approach, researchers identify a range of chemical processes performed 

easily by various types of bacteria and insert these processing abilities into 

industry-standard yeast cells. In one case, the result was an efficient way to 

manufacture simple, yet high-value chemicals called methyl halides, used as 

agricultural fumigants and as fuel ingredients, starting with readily available 

plant matter such as corn stalks, sugar cane, and switchgrass.17 Top-down 

synthetic biology is made easier through the use of increasingly accessible and 

inexpensive DNA sequencing and DNA synthesis technologies. Scientists can 

use them to “trawl” for bacterial genes that perform useful tasks and then 

copy and paste that DNA into yeast, without ever touching (or laboriously 

culturing) the bacteria, as was once required.18 

Figure 4: Example of a top-down approach to synthetic biology.

Bacterial DNA is sequenced, synthesized, 

and inserted into yeast cells

Researchers identify and isolate

specic chemical processes 

performed easily by bacteria

Modified yeast cells perform 

new or enhanced chemical 

processes and functions

Bacteria (metabolically exible)

Yeast (highly productive)
SCIENCE OF SYNTHETIC BIOLOGY II

45

Bottom-Up Approach

In bottom-up synthetic biology, which is relatively new and significantly more 

challenging, scientists aim to build living systems from raw materials starting 

with non-living components. For example, a team of scientists is aiming to 

create completely artificial systems using only non-living materials that mimic 

the behavior of actual cells. The products of this research are called chemical 

cells, or “Chells.”19 Bottom-up approaches also include efforts to create genetically engineered circuits and switches to turn specific functions on and off in 

response to identified stimuli. In some cases, the bottom-up approach could 

theoretically result in an entirely new 

organism or material with functions 

that may be different from currently 

existing organisms or cells. In other 

cases, parts with known functions may 

function differently when assembled 

into a new material or organism.

Bottom-up approaches are sometimes 

characterized by their reliance on 

assembling systems from chemically 

synthesized standardized parts that 

perform desired functions in a predictable manner and can be interchanged.20 

Like Legos® or computer components, a 

goal of this work is to develop a set of 

basic chemically synthesized pieces with 

identified and predictable functionality 

across different platforms. Exemplifying 

this strategy, the Registry of Standard 

Biological Parts, or “BioBricks,”TM physica lly houses a n open cata log of 

standardized DNA parts that encode 

basic biological functions and can be 

easily combined and exchanged among Figure 5: Example of a bottom-up approach 

to synthetic biology.

Assembly of raw materials 

(non-living components)

Catalog of standardized DNA parts 

that encode basic biological functions

Systems are 

assembled from 

standardized parts that 

can be interchanged

Researchers are aiming to create

synthetic systems that mimic the

behavior or functions of living cells

(e.g., genetically engineered

circuits or switches)
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

46

different devices and laboratories.21 These standardized parts are made available to the public free of charge to further research in this field, and they are 

central to the annual International Genetically Engineered Machine (iGEM) 

student competition.

Defining Synthetic Biology

Despite these historical antecedents and complementary methodologies, providing a single definition for synthetic biology is a challenge even to those 

active in the field. Synthetic biology has attracted interest and investment 

from a range of different specialties. Biologists, chemists, engineers, and 

others bring their collective knowledge and expertise to this inherently interdisciplinary science. For this reason, synthetic biology may be viewed from 

various perspectives, which together help to explain its utility and versatility. 

A common thread is that synthetic biology is a scientific discipline that relies 

on chemically synthesized DNA, along with standardized and automatable 

iGEM

The iGEM competition resembles a giant science fair for budding synthetic biologists. iGEM is a global synthetic biology competition involving mostly undergraduate students, although non-synthetic biology faculty, and high school students also 

participate. At the heart of the competition is BioBricks, a repository of standard DNA 

parts. Several months before the actual competition, competing teams receive a kit 

of DNA parts. Working at their own schools over a summer, teams design and build 

synthetic systems that operate in living cells. Examples of recent projects include an 

arsenic biosensor, wintergreen-scented bacteria, and color-coded microbes. Teams 

earn medals in a range of categories. Among the more popular of these is “human 

factors.” Here, competitors win points for innovations that directly affect how people 

work together. Beyond building biological systems, the broader goals of iGEM include 

growing and supporting a community of science guided by social norms.
SCIENCE OF SYNTHETIC BIOLOGY II

47

processes, to address human needs by the creation of organisms with novel or 

enhanced characteristics or traits. 

To a biologist, synthetic biology is a window through which to understand 

how living things operate. It provides a direct and compelling means to test, 

through sequencing, modeling, and reproduction, our current understanding of the life sciences. The ability to model and manipulate living systems 

using synthetic biology is yielding new knowledge that will better define the 

functions of genes and physiological systems. In addition to advancing basic 

science, synthetic biology has important potential applications for medicine, 

including the design of safe and effective vaccines and targeted approaches to 

detect and cure diseases like cancer (see pp. 64-68). 

From the perspective of a chemist, synthetic biology is a tool for manufacturing novel molecules and molecular systems for various uses. Scientists have 

used synthetic biology to directly manipulate chemical reactions in living 

systems, for example, in hopes of making medicines quickly and inexpensively.22 They have also produced, on a small scale, novel biofuels that can 

harness energy from plants and the sun.23 Collectively, these methods could 

reduce the use and deleterious effects of hazardous chemicals and petroleumbased products.

Synthetic biology viewed through an engineering lens is an opportunity to 

apply the techniques and tools of engineering to complex living organisms. 

Many aspects of engineering are based on the principle of standardization, 

which enables the reliable production of useful commodities. Engineers 

working in the field of synthetic biology hope to bring a similar level of 

standardization, predictability, and reproducibility to biology. Examples of 

engineered biological systems currently under study include synthetic systems 

that perform sophisticated medical functions—measuring components in 

body fluids and adjusting them through targeted administration of therapies—as well as biologically engineered “microcleansers” that can clean up oil 

spills or other forms of industrial waste.24
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

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Is Synthetic Biology New?

The answer to this question is complex. Some scientists see synthetic biology 

as a revolutionary and qualitatively new field of science.25 Others see current 

developments in the field as incremental advances in the decades-long growth 

of molecular biology, genetic engineering, and microbiology.26 The term synthetic biology itself was first used as early as 1974 by Waclaw Szybalski who 

saw molecular biology’s promise evolving from description to manipulation of 

genetic systems, heralding a new era of synthetic biology.27

One characteristic that distinguishes the synthetic biology of today from the 

molecular biology of years past is the significant role played by standardized 

parts, computers, and automation, accelerating a trend prevalent throughout biotechnology. Companion fields like nanotechnology and biomedical 

imaging share a reliance on automation and reusable, standardized parts. 

Figure 6: Overview of one process using synthetic biology techniques to produce synthetic cells. 

(Courtesy of J. Craig Venter Institute)

Genomic

DNA

Sequence

DNA sequence

databases

Synthetic cell Transplant to

recipient cell

Synthetic

genome

Genome

assembly in

yeast

DNA

synthesis

Genome

design

GenBank

(USA)

EMBL

(Europe)

DDJB

(Japan)

CAMERA

Metagenomic

Database

(USA)

Natural cell
SCIENCE OF SYNTHETIC BIOLOGY II

49

Recent technological advances and economic efficiencies in DNA synthesis 

and sequencing permit synthetic biologists to make, move, and manipulate 

DNA on a much larger scale than was possible only a few years ago. In contrast to conventional research in biology, the quest for predictable functions 

and standardization lies at the heart of synthetic biology. In this way, the field 

reflects the influence of engineering on its development. 

The Future of Synthetic Biology

Synthetic biology holds great promise as a route to develop novel applications for medicine, agriculture, energy, and other industries. For example, 

the future may hold microorganisms that are “tailor-made for production of a 

specific chemical from a specific starting material . . . .” 28 Few of these potential products are anticipated immediately, however, and considerable technical 

and intellectual challenges remain. 

Building a single cell from parts in the laboratory is a vastly different challenge than building an organism that interacts effectively and predictably in 

nature.29 The design of synthetic or artificial organisms that can survive in 

natural environments is likely to be more challenging and unpredictable than 

doing so in a controlled setting.30 It is extremely difficult to anticipate with 

confidence how a synthetic organism will react to and interact with a novel 

natural environment, adding to concerns about the risks of some applications 

of this field (see Chapter 3 for further discussion of applications).

Complexity and variation are linked. They both reflect the fact that DNA 

alone is not sufficient to create the biological functions necessary for the 

creation of biofuels, vaccines, soil sensors, or any desired product of synthetic biology. DNA can only function if it exists within an environment 

that provides the cellular components such as ribosomes, proteins, and other 

structures necessary to read, translate, and implement its genetic code. How 

any specific DNA sequence functions in a cell is also dependent on secondary modifications in its structure (though methylation) or folding pattern 

(through changes in histone proteins) that can promote or inhibit the transcription of genes, an area known as epigenetics. Much is still unknown 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

50

regarding the interactions between and within cells, actual or “artificial,” as 

well as between cells and their environments.

Currently, the behavior of synthetic biological systems remains unpredictable.31 Function cannot typically be accurately predicted based on DNA 

sequence alone or by the shape and other characteristics of the proteins and 

the biological systems for which it codes.32 Also unknown is how synthetic 

biological systems will evolve. In most cases, biological systems that have been 

engineered by scientists quickly revert to “wild type” (i.e., evolve to lose their 

engineered function rather than gain a new one).33 Although this notion may 

be reassuring, it does not rule out the possibility that systems might evolve in 

unpredictable and harmful ways, particularly if released outside the laboratory.

The potential promise of synthetic biology is immense. Research in synthetic 

biology has led to the development of genetic circuits and modules with predictable behavior, creation of novel combinations of cells in the laboratory that 

behave synergistically, and ever-expanding DNA construction capabilities.34 

The field, however, is young. Our understanding of complexity and variation 

in natural and synthetic parts and systems is far from complete, and the technical tools and skills required for large-scale synthesis and production continue 

to be refined. If carefully nurtured and guided, however, synthetic biology may 

provide an opportunity to integrate engineering and the biological sciences 

into the living world, with potential benefits to national and international 

security, food and energy supply, public health, and economic well-being.
SCIENCE OF SYNTHETIC BIOLOGY II

51

1 Jackson, D.A., Symons, R.H., and P. Berg. (1972). Biochemical method for inserting new 

genetic information into DNA of simian virus 40: Circular SV40 DNA molecules containing 

lambda phage genes and the galactose operon of escherichia coli. Proceedings of the National 

Academy of Sciences 69(10):2904–2909.

2 Jaenisch, R., and B. Mintz. (1974). Simian virus 40 DNA sequences in DNA of healthy adult 

mice derived from preimplantation blastocysts injected with viral DNA. Proceedings of the 

National Academy of Sciences 71(4):1250–1254. 

3 Twyman, R. (2003). Transgenic Mice. 

Available at: http://genome.wellcome.ac.uk/doc_WTD021044.html.

4 Berg, P. (2004). Asilomar and recombinant DNA. Available at: http://nobelprize.org/nobel_

prizes/chemistry/laureates/1980/berg-article.html. 

5

 Fredrickson, D.S. (2001). The Recombinant DNA Controversy: A Memoir. Washington, 

D.C.: American Society for Microbiology Press.

6 Goeddel, D., et al. (1979). Expression in Escherichia coli of chemically synthesized genes for 

human insulin. Proceedings of the National Academy of Sciences 76(1):106-110. 

7 Junod, S.W. (2007). Celebrating a milestone: FDA’s approval of the first geneticallyengineered product. Selections from FDLI Update Series on FDA History. Available at: http://

tinyurl.com/ybdj3sn. 

8 Gregory, T.R. (2010). Animal Genome Size Database. Available at: www.genomesize.com; 

Gibson, D.G., et al. (2010). Creation of a bacterial cell controlled by a chemically synthesized 

genome. Science 329(5987):52-56.

9 Endy, D., Terman Fellow and Assistant Professor of Bioengineering, Stanford University. 

(2010). Overview and Context of the Science and Technology of Synthetic Biology. 

Presentation to the Presidential Commission for the Study of Bioethical Issues, July 8, 2010. 

Available at: www.bioethics.gov/transcripts/synthetic-biology/070810/overview-and-contextof-the-science-and-technology.html. 

10 Terrill, D., Senior Vice President and General Counsel for International Legal and 

Regulatory Affairs Integrated DNA Technologies. (2010). Biosafety and Biosecurity. 

Presentation to the President’s Commission for the Study of Bioethical Issues, September 

14, 2010. Available at: http://www.bioethics.gov/transcripts/synthetic-biology/091410/

biosecurity-and-biosafety.html.

11 Gibson, D.G., et al., op cit.

12 Petsko, G.A. (2010). Hand-made biology. Genome Biology 11:124.

13 Aldrich, S.C., Newcomb, J., and R. Carlson. (2007). Genome synthesis and design futures: 

Implications for the U.S. Economy. Cambridge, MA: Bio-Era. Available at: www.bio-era.net/

reports/genome.html. Current prices for gene synthesis vary, but have been observed as low 

at $0.39 per base pair. See, e.g., Syd Labs. Gene synthesis service. Available at: http://tinyurl.

com/2amzqwl. 

14 Fritz, B.R., et al. (2010). Biology by design: From top to bottom and back. Journal of 

Biomedicine and Biotechnology 2010:232016. 

15 Nature Biotechnology Editors (2009). Unbottling the genes. Nature Biotechnology 27:1059. 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

52

16 Gil, R., Silva, F.J., and P.J. Moya. (2004). Determination of the core of a minimal 

bacterial gene set. Microbiology and Molecular Biology Reviews 68(3):518–537; Luisi, 

P.L., Ferri F., and P. Stano. (2006). Approaches to semi-synthetic minimal cells: A review. 

Naturwissenschaften 93(1):1–13; Glass, J.I., et al. (2006). Essential genes of a minimal 

bacterium. Proceedings of the National Academy of Sciences 103(2):425-430.

17 Bayer T.S., et al. (2009). Synthesis of methyl halides from biomass using engineered 

microbes. Journal of the American Chemical Society 131(18):6508–6515.

18 National Science Advisory Board for Biosecurity (NSABB). (2010). Addressing Biosecurity 

Concerns Related to Synthetic Biology. Available at: http://oba.od.nih.gov/biosecurity/pdf/

NSABB%20SynBio%20DRAFT%20Report-FINAL%20(2)_6-7-10.pdf. 

19 King, J. (2010). Slippery cellularities: Analysis. Seed. Available at: http://seedmagazine.com/

content/article/slippery_cellularities/; Cronin, L., et al. (2006). The imitation game—a 

computational chemical approach to recognizing life. Nature Biotechnology 24:1203-1206.

20 National Science Advisory Board for Biosecurity. (2010). Addressing Biosecurity Concerns 

Related to Synthetic Biology. op cit., page ii.

21 The BioBricks Foundation. Available at: http://bbf.openwetware.org/.

22 Martin, V.J., et al. (2003). Engineering a mevalonate pathway in Escherichia coli from 

production of terpenoids. Nature Biotechnology 21(7):796-802.

23 Dellomonaco, C., Fava. F., and R. Gonzalez. (2010). The path to next generation biofuels: 

Successes and challenges in the era of synthetic biology. Microbial Cell Factories. 9(3). 

Available at: www.microbialcellfactories.com/content/9/1/3. 

24 Endy, D., op cit.; Weiss, R., Associate Professor, Department of Biological Engineering 

and Department of Electrical Engineering and Computer Science, Massachusetts Institute 

of Technology. (2010). Synthetic Biology: What New Methods and Products are Being 

Developed? Presentation to the Presidential Commission for the Study of Bioethical Issues, 

September 13, 2010. Available at: www.bioethics.gov/transcripts/synthetic-biology/091310/

synthetic-biology-what-new-methods-and-products-are-being-developed.html. 

25 Endy, D., op cit. 

26 Brenner, S., Senior Distinguished Fellow of the Crick-Jacobs Center, The Salk Institute. 

(2010). Reflections for the Future. Presentation to the Presidential Commission for the 

Study of Bioethical Issues, September 14, 2010. Available at: www.bioethics.gov/transcripts/

synthetic-biology/091410/reflections-for-the-future.html. 

27 Szybalski, W. (1974). In Vivo and in vitro initiation of transcription. In Control of Gene 

Expression, Kohn, A., and A. Shatkay (eds.). New York: Plenum Press. Page 405; see also

Szybalski, W., and A. Skalka. (1978). Nobel prizes and restriction enzymes. Gene 4(3):181–

182.

28 Keasling, J. D. (2010). Manufacturing molecules through metabolic engineering. Science

330:1355-1358.
SCIENCE OF SYNTHETIC BIOLOGY II

53

29 European Commission Framework Programme 6 Reference Contract 15357 (NEST). 

(2005). Synbiology: An Analysis of Synthetic Biology Research in Europe and North America. 

Available at: www2.spi.pt/synbiology/documents/SYNBIOLOGY_Literature_And_

Statistical_Review.pdf.

30 De Vriend, H. (2009). Constructing Life: Early social reflections on the emerging field of 

synthetic biology (Working Document 97). The Hague: Rathenau Institute. Available at: 

www.synbiosafe.eu/uploads/pdf/Rathenau%20Constructing%20Life%202006.pdf. 

31 Keasling, J.D., op cit.

32 National Research Council. (2010). Sequence-based Classification of Select Agents: A Brighter 

Line. Washington, D.C.: The National Academies Press. Available at: www.nap.edu/catalog.

php?record_id=12970; National Science Advisory Board for Biosecurity, op cit.

33 Collins, J.J., University Professor, William F. Warren Distinguished Professor, Professor of 

Biomedical Engineering, and Co-Director, Center for BioDynamics, Boston University. 

(2010). Synthetic Biology: What New Methods and Products are Being Developed? 

Presentation to the Presidential Commission for the Study of Bioethical Issues, September 

13, 2010. Available at: www.bioethics.gov/transcripts/synthetic-biology/091310/syntheticbiology-what-new-methods-and-products-are-being-developed.html.

34 Relman, D.A. (2010). Consideration of Advances in Synthetic Biology in Relation to the 

NSABB Report Addressing Biosecurity Concerns Related to Synthetic Biology: (1) Emerging 

Scientific Advances and (2) Creation of a Bacterial Cell Controlled by a Chemically 

Synthesized Genome. Presentation to National Science Advisory Board for Biosecurity 

(NSABB), October 19, 2010. Available at: http://oba.od.nih.gov/oba/biosecurity/meetings/

Oct2010/Consideration_of_Advances_in_SynBio_Slides.pdf. 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

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55

chapter 3

Applications, Benefits, and Risks
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

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Synthetic biology offers opportunities to apply biological and engineering 

principles to benefit humankind in unprecedented ways. Clean energy 

sources, targeted medicines and more efficient vaccine production, new 

chemicals, environmental cleansers, and hardy crops are some of the potential applications of this burgeoning field of science. While most of the fruits 

of synthetic biology remain in early stages of development, some applications 

are expected to come to market within a few years.1

 Success in these research 

efforts will yield new jobs as novel products and product streams develop. The 

pace of acceleration of synthetic biology is likely to increase dramatically in 

the years ahead. 

Despite its promise, synthetic biology raises concerns about risks to human 

health, the environment, and biosecurity. Some of these potential harms 

include unanticipated adverse human health effects, negative environmental 

effects (anticipated or unanticipated) from field release and dual-use concerns 

when research undertaken for “legitimate scientific purpose...may be misused 

to pose a biologic threat to public health and/or national security.”2

This chapter provides an overview of the potential applications, benefits, and 

risks of synthetic biology. Because renewable energy is expected to yield the 

first large-scale commercial products of synthetic biology, the Commission 

discusses this area first. Next, the Commission reviews potential health applications and benefits. Many products remain in research and development, 

but a few are nearing commercialization. Finally, the Commission provides 

a summary of potential agricultural, environmental, and biosecurity applications of synthetic biology, all of which are in more preliminary stages of 

development. Within these discussions the potential health, security, and 

other risks are examined, as well as anticipated technical challenges.

Renewable Energy Applications of Synthetic Biology

In general, biofuels are renewable energy sources derived from biomass, which 

includes material derived from plants, animals, and organic waste. Several 

methods can be used to harvest energy from biomass, including burning, 

chemical treatment, or biodegradation using the metabolic power of microorganisms. Processing biomass into biofuels or electricity through more complex 
Applications, Benefits, and Risks III

57

chemical and biochemical reactions, as opposed to simple combustion, limits 

environmental impact by minimizing the production of waste and decreasing 

net greenhouse emissions. Current practices for farming biomass for energy 

use employ a range of biological sources including grains, grasses, oil seed 

crops, trees, sugar, and corn. 

Ethanol is the most common biofuel worldwide. It is produced mainly from 

corn or sugar cane. Biodiesel, another currently used biofuel, is made from 

vegetable oils, animal fats, or recycled restaurant grease. There are challenges 

to widespread commercial development of either of these fuels. For ethanol 

production, challenges include inefficiencies and energy costs for production, 

as well as concerns about the volume of plant sources needed and possible collateral impact on food prices. Biodiesel also involves significant energy costs 

for production. 

Promise and Potential Benefits

Biofuels and related products produced through synthetic biology offer 

the potential to reduce global dependence on fossil fuel, cut harmful emissions, and minimize economic and political volatility surrounding fossil 

fuel reserves. Some biofuels produced with synthetic biology processes are 

expected to be available commercially within the next few years. Other 

research may not yield commercial products for a decade or more.

The various synthetic biology alternatives to current biofuel production 

methods include producing cellulosic ethanol (derived from cell walls rather 

than corn) and manufacturing other bioalcohols with synthetically manipulated biomass. Biofuel can also be produced from modified algae that use the 

natural process of photosynthesis to manufacture bio-oils, such as biodiesel, 

more easily than current chemical processes.3

The biochemical conversion of biomass into energy involves chemical reactions 

performed by biological systems. Enzymes in microorganisms such as bacteria 

break down biological materials into their component parts, from which energy 

can be extracted more easily. Perhaps the simplest example of biochemical 

conversion is a backyard composting bin, in which microorganisms gradually 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

58

degrade vegetation in the presence of oxygen. As is apparent from the surge of 

warm air that emerges upon opening the lid of the bin, this form of bioconversion is an energy-yielding process.

Synthetic biologists aim to improve the speed and efficiency of converting 

biomass into advanced, second- or third-generation biofuels with cleaner and 

more favorable energy-usage profiles.4

 This challenge may be met by creating “super-fermenting” yeast and bacteria through synthetic biology. These 

organisms have the potential to boost the power and potential of current 

industrially used microorganisms by means of new or altered genes. Synthetic 

biology also offers new biomass sources, or feedstocks, that are more efficient, 

reliable, low-cost, and scalable than current sources. These include forest and 

agriculture residues, some grasses, algae, oilseeds, and potentially sewage.5

Aside from biofuels, synthetic biology may also play an important environmental role by harnessing energy in novel, cleaner ways than traditional 

non-renewable energy production processes. Large global reserves of hydrocarbons, such as oil, gas, shale, and oil sands, might be leveraged with synthetic 

biology tools. Coal bed methane, for example, is a globally available source 

of natural gas. Its reserves are vast and largely untapped. Synthetic biology 

research is underway to harvest this methane through microbial digestion and 

other processes.6

Bioalcohols 

Unlike ethanol derived from corn or sugar cane, cellulosic ethanol is made 

from cellulose fibers, a major component in the cell walls of all plants. 

Processing plant biomass not used for food, for example, waste corn stalks, 

straws, grass clippings, prairie grasses, and wood chips, could reduce 

economic and other pressures imposed by relying on corn for ethanol. 

However, cellulosic ethanol is a relatively low-yield bioalcohol and, like 

ethanol fuel derived from more conventional chemistries, still tends to 

corrode storage and transport equipment.
Applications, Benefits, and Risks III

59

A potentially more promising bioalcohol made by synthetic biology and used 

for energy production is butanol. Like ethanol, butanol is produced by the 

fermentation of sugars and starches or through the breakdown of cellulose. 

The crude product is then refined to make usable fuel. A particular advantage of butanol (and a similar biofuel called isobutanol) is that it can be used 

New Product Pipeline: Bioalcohols

Amyris (Emeryville, California) is using a synthetic biology platform to convert sugar 

into a range of products, including yeast-derived cellulosic alcohol fuel. The oil-based 

fuel is harvested in a similar fashion to the technique used by the Joint Bioenergy 

Institute (akin to separating cream from milk).7

British Petroleum and DuPont created a partnership to develop, produce, and market biobutanol.8

Gevo (Englewood, Colorado) genetically engineered bacteria to make biobutanol, a 

promising new biofuel. It also successfully converted cellulosic biomass into isobiobutanol and converted the fuel into jet fuel.9

Global Bioenergies (Evry, France) created yeast and bacteria with the capacity to 

transform sugar into hydrocarbons chemically identical to those distilled from oil. 

Bio-isobutane is the targeted end product; this hydrocarbon gas can be converted 

into high-octane gasoline.10

The U.S. Department of Energy’s Joint Bioenergy Institute (Emeryville, California) is 

using synthetic biology to biodegrade plant biomass into biodiesel, which is skimmed 

off the top of a fermentation broth.11

LS9, Inc. (South San Francisco, California) developed the UltraCleanTM product 

line that employs synthetic biology to produce its DesignerMicrobesTM. These 

microorganisms use sugar cane or cellulosic biomass to create high-energy transportation fuels.12

The various commercial products and products presented and described in this report 

are intended to provide examples of current projects, not to endorse any particular entities.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

60

directly in a traditional gasoline-powered engine. It also has a relatively highenergy density, resulting in better gas mileage than ethanol.13 Some bacteria 

have the built-in enzymes to manufacture butanol, but the natural process is 

not very fast or high-yield. Synthetic biologists have engineered the easy-tomanipulate bacterium E. coli to improve this bacterial biochemical reaction 

to make butanol more industrially useful.14

Photosynthetic Algae

Another tool for creating biofuels via synthetic biology is through the use of 

photosynthetic algae. Algae are low-input, high-yield feedstocks that, under 

experimental conditions, produce substantially more energy per acre than 

land crops such as corn or soybeans.15 To create biofuel from algae, the cells 

are grown, harvested, and treated chemically or thermally to recover the oil 

content inside algal cells, the so-called “bio-oil.” While experimental yields 

have not yet been duplicated on a commercial scale, an alternative strategy 

currently under development with synthetic biology is engineering algal cells 

to secrete oil continuously through their cell walls and thereby increase yield. 

This time-saving step may support large-scale industrial operations in the 

near future.16

Proponents of farming algae note that it is biodegradable and therefore relatively harmless to the environment if spilled. Algae can also be grown on 

land and in water that is otherwise unsuitable for crops and food production. 

Making bio-oils using algae is expected to be less polluting and more efficient 

than converting vegetable oils or animal fats into biofuel.17

Through its capacity to consume carbon dioxide, algae offer the added benefit 

of mitigating greenhouse gas emissions. Unlike ethanol, algae-derived biooils, such as gasoline, diesel, and jet fuels, have been found to have very 

similar physical and chemical properties in comparison to currently used 

petroleum-based products, suggesting that these fuels are likely to be compatible with current transportation technologies and infrastructure.
Applications, Benefits, and Risks III

61

Hydrogen Fuel

Hydrogen fuel is an additional area of focus for commercial applications 

of synthetic biology. Hydrogen is a highly desirable fuel source because it 

is clean-burning, producing water as a by-product. Hydrogen also has the 

second highest energy density per unit of weight of any known fuel.22

Several possible routes to generate biohydrogen are under investigation. One 

method uses engineered E. coli as a host organism to produce hydrogen in 

New Product Pipeline: Photosynthetic Algae

Aurora Algae (Alameda, California and Florida) is growing algae in open-pond systems consisting of readily available seawater. The pilot facility in Florida produces 

approximately three tons of algal biomass per year, with the ultimate goal of producing 40,000 tons of algal biomass per year.18

Joule (Cambridge, Massachusetts) engineers algae to make and secrete liquid hydrocarbons, bioethanol, and other fuel materials from sunlight and waste carbon 

dioxide (the sole feedstock) in a single-step, continuous process. Pilot operations are 

currently underway, with commercial development slated for 2012.19

Solazyme (South San Francisco, California) uses photosynthetic algae to produce 

an oil-based fuel, Soladiesel®, at industrial manufacturing scale with production 

capabilities currently in the tens of thousands of gallons. In July 2010, Solazyme 

delivered 1,500 gallons of algal-derived jet fuel to the Navy.20

Synthetic Genomics Inc. (La Jolla, California) engineered algal strains to create 

a biocrude oil that can be used as a feedstock in refineries, using a continuous 

biomanufacturing process that sidesteps the intermittent cycle of growing and harvesting. In July 2009, Synthetic Genomics entered into a $600 million multi-year 

agreement with ExxonMobil.21

The various commercial products and products presented and described in this report 

are intended to provide examples of current projects, not to endorse any particular entities.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

62

addition to other biofuels.23 Engineered algae are also being examined as 

sources of biohydrogen.24 Finally, and perhaps most promisingly, researchers 

are investigating ways to produce high yields of hydrogen using starch and 

water via a synthetic enzymatic pathway.25 The latter system is particularly 

attractive, as it may enable sugar to be converted into hydrogen fuel inside 

a vehicle itself. This would mitigate the problem of storage that exists today, 

as hydrogen takes up inordinate amounts of space at regular atmospheric 

pressure and compression of the gas requires energy and makes storage both 

difficult and dangerous.26

The synthetic processes being explored, if successful, will differ markedly 

from the current method of producing hydrogen fuel, which involves converting natural gas using steam. Natural gas techniques are costly, inefficient, and 

heavily reliant on fossil fuels. The synthetic biology-driven process is expected 

to cost significantly less while providing substantially higher yields, though 

research remains early in the developmental pipeline. 

Risks and Potential Harms

Synthetic biology offers many potential methods to improve energy production and reduce costs, which deservedly generate attention and enthusiasm. 

A full assessment of these promising activities requires comparable attention 

to the current limitations, challenges, and anticipated risks or harms. This 

assessment is particularly important at this time because renewable energy 

applications may be the first synthetic biology products to come to market.

Contamination by accidental or intentional release of organisms developed 

with synthetic biology is among the principal anticipated risks. Unlike 

synthetically produced chemicals, which generally have well-defined and 

predictable qualities, biological organisms may be more difficult to control. 

Unmanaged release could, in theory, lead to undesired cross-breeding with 

other organisms, uncontrolled proliferation, crowding out of existing species, 

and threats to biodiversity.27
Applications, Benefits, and Risks III

63

Consider biofuel production systems that employ synthetic biology and pondgrown algae. One hypothetical, worst-case scenario is a newly engineered type 

of high-yielding blue-green algae cultivated for biofuel production unintentionally leaking from outdoor ponds and out-competing native algal growth.28

A durable synthetic biology-derived organism might then spread to natural 

waterways, where it may thrive, displace other species, and rob the ecosystem 

of vital nutrients, with negative consequences for the environment. 

This scenario is theoretical. Considering it and developing appropriate precautions is nevertheless appropriate because of the rapid development of synthetic 

biology-generated photosynthetic algae for fuel production and the uncertain nature of the harm that may arise from accidental release. One of the 

advantages of synthetic biology is that many of the tools being developed 

include strategies to remediate such risks. Some of the approaches proposed 

include the engineering of so-called “terminator” genes or “suicide” switches 

that can be inserted into organisms, precluding them from reproducing or 

surviving outside of a laboratory or other controlled setting in the absence of 

unique chemical conditions.29 Some are clearly sufficient to neutralize the risk 

of release, and others require further study as synthetic biology progresses.

Another risk in the energy sector is harm to ecosystems from the required 

dedication of land and other natural resources to production of biomass as 

feedstock for biofuels. If large areas of land were to be dedicated to biofuel 

development, this could put new and intense pressures on land, potentially 

affecting food production, communities, and current ecosystems. Because 

these applications of synthetic biology are still young, the impact of biofuel 

production on land use remains unknown. Some argue that efforts to develop 

and grow additional cellulosic biofuel will dramatically change and adversely 

impact the way land is used in the United States and abroad.30 Others suggest 

that biofuel production can proceed safely with only minor adjustments in 

current land use practices.31 Existing biodiverse prairie and meadow grasses 

may actually enhance the growth of feedstock for second-generation biofuels.32

On balance, many anticipate the potential efficiencies and attendant reduction 

in reliance on fossil fuels offered by energy production using synthetic biology 

would offset anticipated risks to the environmental ecosystem as it exists today. 

But considerable uncertainty remains.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

64

Health Applications of Synthetic Biology

Synthetic biology has the opportunity to advance human health in a variety 

of ways. Improved production of drugs and vaccines, advanced mechanisms 

for personalized medicine, and novel, programmable drugs and devices for 

prevention and healing are among a few of the expected achievements. 

Promise and Potential Benefits

There is a long tradition of employing plants and other biological organisms 

to detect and cure human disease. Genetic engineering technology has been 

used for more than three decades in medicine to engineer bacteria with the 

ability to produce commercially relevant molecules like insulin and vaccines 

for hepatitis B virus and human papillomavirus.33 Synthetic biology applications related to health build on this history, but most remain early in the 

research and development pipeline. The quick pace of biomedical research in 

general, and synthetic biology research in particular, suggests that this could 

change soon. This research is being conducted at universities and biotechnology or synthetic biology companies in the United States and overseas.34

Medicines

Synthetic biologists have refined a chemical technique called metabolic 

engineering to enhance the production of medicines. Through this process, 

scientists alter an organism’s metabolic pathways—the series of chemical 

reactions that enable the organism to function at the cellular or organism 

level—in order to better understand and manage how those pathways work. 

They can redesign these pathways to produce novel products or augment the 

production of current products, like drugs. Synthetic biology can also be used 

to engineer molecules and cells that express proteins or pathways responsible 

for human disease. At some point these products may be used in efficient, 

large-scale screening methods to identify novel drugs for disease treatment 

or prevention.
Applications, Benefits, and Risks III

65

One well-known example of synthetic biology in medicine is the re-engineering of a microorganism to make the antimalarial drug artemisinin more 

cheaply and efficiently. Malaria affects approximately two to three hundred 

million people each year and results in between 700,000-1,000,000 deaths, 

largely among young children in sub-Saharan Africa.35 Artemisinin is a 

naturally occurring chemical derived from the plant artemesia, or sweet 

wormwood. It is an effective malaria treatment, but is difficult to obtain 

due to limitations on plant yield and high production costs. To address 

this problem, synthetic biologists at the University of California genetically 

engineered E. coli bacteria to produce a high volume precursor that can be 

chemically converted to artemisinin.36 This semi-synthetic artemisinin is 

being developed today by the pharmaceutical company Sanofi-Aventis in collaboration with the California researchers and the Institute for OneWorld 

Health. If successful, these efforts should substantially reduce the drug’s production cost and increase and stabilize world supply. Full-scale production is 

expected to begin shortly, with marketing expected in 2012.37

Vaccines

Synthetic biology techniques are also being studied and used to accelerate the 

development of vaccines. Influenza vaccine production is among the key areas 

of focus. To develop a vaccine, one first needs to identify the virus strain, 

with its unique genetic code, against which the vaccine will be used. Synthetic biology tools, including rapid, inexpensive DNA sequencing combined 

with computer modeling, may streamline production time by accelerating 

this first step. 

“Making a few micrograms of artemisinin would have been a neat scientific trick,” 

said Dr. Jay Keasling, whose laboratory originally developed the synthetic biological concept for making artemisinin. “But it doesn’t do anybody in Africa any good 

if all we can do is a cool experiment in a Berkeley lab. We needed to make it on an 

industrial scale.” 38
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

66

One industry group is developing a “bank” of synthetically created seed 

viruses for influenza vaccines that it hopes will enable more rapid vaccine 

production by reducing virus identification time.39 DNA-based vaccines 

created “on-the-spot” to match actual, circulating viral genetic material may 

be a more efficient process for producing vaccine seed stock in the future.40

However, these strategies are preliminary and may prove no more efficient or 

effective than conventional reverse engineering techniques. More research and 

experience is needed.

Advancing Basic Biology and Personalized Medicine

Twenty years ago, cloning, or replicating, a single gene was enormously time 

consuming. Today, such a task can be done in minutes by a machine, a development that has fueled rapid advances in synthetic biology. The ability to 

easily manufacture and manipulate DNA in the laboratory has enhanced 

scientists’ productivity and opened new directions for scientific exploration. 

Researchers see great potential for synthetic biology to advance knowledge of fundamental biological principles. Expanding the DNA “alphabet” 

beyond its traditional four nucleotides—A, C, G, and T—to include nonnaturally occurring nucleotides also gives synthetic biologists more flexibility 

in studying, detecting, and treating disease. For example, scientists recently 

used polymerase chain reaction (PCR) with novel nucleotides, a process 

that increases DNA’s information potential and thus enables the manufacture of proteins with new properties.41 To this end, researchers have already 

developed diagnostic tests using these DNA nucleotides to screen for human 

immunodeficiency virus, cystic fibrosis, and other diseases.42

In general, personalized medicine aims to apply the science of genomics 

to develop individually tailored, and thereby more effective, approaches to 

disease prevention and health care.43 Synthetic biology offers useful strategies 

for advancing this goal. Many current cancer treatments focus on non-selective cell killing or on delivery to specific tissues. A growing body of knowledge 

supporting a molecular classification of tumors may facilitate the development 

of specifically designed detection devices matched to individual tumors. A 

synthetic biology approach currently under study is a cancer treatment that 

focuses on up to six cellular identifiers rather than one, effectively enabling 
Applications, Benefits, and Risks III

67

the treatment to be targeted more carefully and precisely toward the cells 

intended to be killed, while sparing healthy ones.44

Custom protein and biological circuit design may eventually enable the delivery of “smart proteins” or programmed cells that self-assemble at disease sites. 

Similarly, synthetic organisms could be developed to create a trigger to deliver 

or withhold treatment depending upon a local disease environment (such as 

low levels of oxygen) and provide targeted killing of cancer cells.45 These and 

other novel approaches to tailored disease treatment may substantially improve 

outcomes and reduce the costs and burden of disease across the population.

While the benefits of synthetic biology to health care may prove monumental, 

significant hurdles remain. With the exception of semi-synthetic artemisinin 

and potential, near-term improvements in vaccine design, most of the anticipated health benefits of synthetic biology remain in the preliminary research 

stage. We are unlikely to see commercial applications from much of the biomedically oriented synthetic biology research for many years, although the 

pace of discovery is unpredictable.

Risks and Potential Harms

In addition to practical challenges, biomedical applications of synthetic 

biology raise potential risks for humans and the environment that are, in part, 

similar to those identified in the biofuels discussion and those commonly 

understood within the biomedical or greater engineering research communities today. Human health risks may arise from adverse effects of intentional 

or inadvertent release of the organisms engineered using synthetic biology. 

Infectious diseases may be transmitted to laboratory workers after needle 

sticks or to family members following airborne transmission of disease agents 

manipulated using synthetic biology techniques. Risks may also accrue to the 

wider human community or the environment if organisms proliferate without 

adequate means to limit reproduction.

Similarly, novel organisms developed with synthetic biology to treat illness 

may trigger unanticipated adverse effects in patients. The use of cell therapies 

of bacterial, or potentially, mixed microbial origin may cause infections or 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

68

unexpected immune responses. New organisms developed with the emerging 

technology of synthetic biology may pose unusual, if not unprecedented, risks 

resulting from their potential as biological organisms to reproduce or evolve.

Many of these risks are qualitatively similar to the risks that arise in horticultural biomedical and biotechnology research. There are well-established 

mechanisms in place to identify and manage future risks (see Chapter 4). Additionally, as with energy applications, internal mechanisms to reliably contain 

function and reduce or eliminate these risks are being developed. “Biological 

isolation,” which is also termed “biosafety engineering,” aims to build in molecular “brakes” or “seatbelts” that restrain growth or replication of partially or 

fully synthetic organisms.46 Synthetic organisms can be engineered to be contained physically or temporally. Additional data are needed to assess how well 

biologically engineered safeguards, such as “kill switches” that activate after a 

defined number of generations, will work. 

Agricultural, Food, and Environmental Applications of Synthetic Biology

Synthetic biology may also help to shift, if not substantially mitigate, some of the 

existing threats to our global food supply and environmental health. These potential benefits are in some ways more preliminary than the expectations for energy 

and health, but research and development in these fields are well underway.

Promise and Potential Benefits

In agriculture, efforts to manipulate crops and breed animals for specific purposes are not new. Many traditional farming practices, from plant breeding 

to animal husbandry, aim to direct evolution to achieve desired outcomes. 

Use of recombinant DNA technology, cloning, and other biotechnology 

tools have enhanced these practices. Taking these activities one step further, 

synthetic biologists are experimenting with high-yield and disease-resistant 

plant feedstocks that can be supplemented with efficient and environmentally friendly microorganisms to minimize water use and replace chemical 

fertilizers.47 Researchers are altering the properties of plants through methods 

that combine metabolic components from various organisms in order to gain 

nutritional benefits, such as higher levels of food-grade protein.48
Applications, Benefits, and Risks III

69

Efforts to remove waste using biological means date to at least 1972, when a 

researcher at General Electric applied for a patent on a form of Pseudomonas

bacteria genetically engineered to digest oil slicks.49 Environmental applications of synthetic biology are generally targeted to pollution control and 

ecological protection. The impact of naturally occurring oil-devouring microorganisms at the site of the 2010 oil spill off the U.S. Gulf Coast, for example, 

demonstrated how these organisms could reduce some types of pollution.50

Synthetic biologists are eager to understand and direct these biological capabilities, or even enhance them, to respond to existing and future waste generated 

by human activities. 

Other environmentally relevant examples of synthetic biology applications 

include laboratory-constructed microbial consortia, known as synthetic biofilms, which are being developed for use as environmental biosensors. These 

sensors could be used, for example, to monitor soil for nutrient quality or 

signs of environmental degradation. The design of biological “wetting agents,” 

or biosurfactants, could increase the efficiency of bioremediation efforts and 

minimize the extent of damage from pollutants.54 Biosurfactants are naturally 

produced by bacteria, yeasts, or fungi and are environmentally friendly in 

freshwater, marine, and terrestrial ecosystems. Synthetic biology may offer the 

ability to enhance the features of microbially produced biosurfactants to tailor 

them to specific spills or otherwise polluted areas.

New Product Pipeline: Crop Enhancement and Pollution Control

A synthetic biology-produced Pyrethium-grown compound may find use as natural 

insecticide.51

Synthetic biology-produced DNA sensors may be able to perform a range of roles, 

including detecting food spoilage and monitoring soil nutrition.52

Synthetic biology technology has been proposed to control biodegradation of a range 

of sources including toxic chemical pollutants such as industrial coolants, solvents, 

explosives, and residues from burning oil, coal, and tar.53
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

70

Risks and Potential Harms

Synthetic biology applications in the context of agriculture, food, and the 

environment raise concerns broadly similar to those raised about genetic engineering in the past and those discussed above with respect to safety, resource 

management, and biodiversity. In brief, these risks include harms to humans, 

plants, or animals from, for example:55

•	 uncontrolled environmental escape or release and attendant disruption to 

ecosystems,

•	 new or sturdier pests—animal or plant—that may be difficult to control, and

•	 increased pesticide resistance and growth of invasive species. 

As in the discussion of energy and health applications, the risks may be assessed 

and managed through existing protections long in use for biomedical and greater 

engineering research. Synthetic biology applications in the context of agriculture, 

food, and the environment may require more targeted efforts, however, including 

use of inbred checks, such as “suicide genes” or “kill switches” to ensure that they 

cannot propagate unintentionally.

Many potential applications of synthetic biology go well beyond the genetic 

engineering practiced throughout the biotechnology industry today. In the 

future, the field may be capable of creating entirely new organisms and 

systems previously unseen in the world today. Synthetic biology’s critics and 

proponents alike worry that creating new organisms that have uncertain or 

unpredictable functions, interactions, and properties could affect ecosystems 

and other species in unknown and adverse ways. The associated risks of escape 

and contamination may be extremely difficult to assess in advance, as such 

novel entities may have neither an evolutionary nor an ecological history.56

Countering these concerns, at least somewhat, is experience showing that 

synthetic cells and systems in research settings have tended to be short-lived 

by comparison to those that have evolved in nature. Scientists have observed 

that synthetic organisms allowed to develop in the laboratory have consistently evolved toward nonfunctionality.57 These are encouraging preliminary 

findings, but they do not eliminate the need for precautions in the event that 
Applications, Benefits, and Risks III

71

a future synthetic organism behaves differently than expected outside of the 

contained laboratory setting. 

Another concern related to synthetic biology’s impact on natural systems—

crops grown for either biofuel or food consumption—is the broader effect 

on how society views and protects biodiversity. Does a chemically synthesized organism increase or decrease biodiversity, as measured by traditional 

taxonomy-based classification schemes? This concept becomes important in 

policy discussions pertaining to the use and potential abuse of land and other 

natural resources.

Biosecurity 

Generally, the term “biosecurity” refers to the efforts needed to prevent 

misuse or mishandling of biological agents and organisms with the intent to 

do harm. The National Science Advisory Board for Biosecurity (NSABB), an 

independent federal advisory committee charged with advising the U.S. government on biosecurity issues and “dual use” research—that which may be 

used for either good or ill—defines the term as follows: “[b]iosecurity refers to 

the protection, control of, and accountability for high-consequence biological 

agents and toxins, and critical relevant biological materials and information, 

to prevent unauthorized possession, loss, theft, misuse, diversion, or intentional release.” 58

Unlike applications and potential applications of synthetic biology in the 

energy, health, agricultural, and environmental sectors, possible benefits in 

the biosecurity arena have not garnered significant public attention. Nor have 

they received comparable investment from academia, industry, or the government. It is nonetheless easy to anticipate some potential benefits. 

Synthetic biology may enhance biosecurity by enabling researchers to identify 

biological agents of concern that may be developed synthetically or semisynthetically. In the same way that the J. Craig Venter Institute “branded” 

the bacterium it synthesized this year with traceable information in the 

organism’s genetic code, researchers may uniquely tag the genetic code of 

new organisms that they develop. When combined with other measures 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

72

to ensure biosecurity, this tagging process may provide an additional and 

effective deterrent to malicious use.

Similarly, biosecurity may be improved using the techniques discussed above 

for applications in energy, human health, agriculture, and the environment. 

As noted, “suicide” genes or terminator technologies built into the genome of 

a new organism to inhibit growth or survival outside of a contained environment may offer particularly effective means to counter biosecurity threats. 

Related tools could be crafted to ensure organism death in the face of particular chemicals or contexts. Uncertainties remain, however, with regard to the 

effectiveness of such strategies.

Concerns about dual use or intentional misuse of synthetic biology to do 

harm are among the most prominent critiques of this emerging technology. 

One of the most widely voiced risks attributed to synthetic biology is that it 

may be used, in the wrong hands, to intentionally create harmful organisms 

for bioterrorism. Recent examples of virus reconstruction using traditional 

recombinant DNA techniques fuel these concerns. These examples include the 

laboratory creation of infectious polio virus, the mycoplasma genome, and the 

1918 strain of influenza virus.59

Frequently lost in these discussions about synthetic biology risks is recognition that DNA alone is not sufficient to create an independently functioning 

biological entity, such as a disease-causing virus that could spread. Despite 

the relative ease of access to known DNA sequences through public databases like GenBank60 (an annotated collection of all publicly available genetic 

sequences), and equivalent databases across the globe, most experts in the 

scientific community agree that mere knowledge of a viral genome is far from 

sufficient to be able to re-constitute it or create a disease-forming pathogen. 

Rather, one must have an appropriate host and conditions for a virus to grow. 

Few individuals or groups today have the financial means or the technical 

skills to accomplish such ends, even when scientifically feasible. As the many 

technical challenges in synthetic biology affirm, it is not yet possible to craft 

functioning biological organisms from synthesized genomic material alone.
Applications, Benefits, and Risks III

73

Risks and Potential Harms

With regard to biosecurity risks arising from synthetic biology, NSABB has 

twice issued reports and made recommendations to the federal government—

first in 2006 and again in 2010.61 In 2006, the group focused on synthesis 

of select agents and toxins, which are defined in law as certain infectious 

components of identified “select agent viruses,” meaning those that the U.S. 

government has found to pose a severe threat to human health.62 Following a 

review of the science at that time, the group made specific recommendations 

to reduce biosecurity risks, many of which the United States has since implemented, such as the establishment of a screening infrastructure for genetic 

sequence providers and others.63

NSABB’s report “Addressing Biosafety Concerns Related to Synthetic 

Biology,” issued in April 2010, offered four specific recommendations to 

ensure biosecurity in the current field of synthetic biology:

•	 Synthetic biology should be subject to institutional review and oversight 

since some aspects of this field pose biosecurity risks.

•	 Oversight of dual use research should extend beyond the boundaries of life 

sciences and academia.

•	 Outreach and education strategies should be developed that address dual use 

research issues and engage the research communities that are most likely to 

undertake work under the umbrella of synthetic biology.

•	 The U.S. government should include advances in synthetic biology and 

understanding of virulence/pathogenicity in efforts to monitor new scientific 

findings and technologies. 

These recommendations reflect an attempt to balance the considerable potential benefits of synthetic biology with the risks resulting from intentional or 

unintentional misuse of this technology and its products. Noticeably absent 

were recommendations to restrict access to genetic sequences separate from 

those components of Select Agents and toxins already limited by the U.S. 

Select Agent regulations (see Chapter 4). In large part, this determination 

appears to reflect the fact, as noted, that sequences alone will not yield, nor 

often be sufficient to predict, functions.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

74

NSABB’s work is not unique. Many experts and interested groups in the 

United States and abroad have recently devoted considerable time and energy 

to evaluating the biosecurity risks of advancing synthetic biology practices.64

This still-young field benefits from a clear consensus among scientists and 

policymakers that biosecurity risks, while perhaps overstated by some, nevertheless are serious and warrant ongoing and proactive re-examination as 

technical capacity evolves. The tools used to mitigate these risks may also be 

the tools to mitigate environmental, health, and other potential risks. The 

tools to address risk depend on an expanding scientific knowledge base as 

much as potential benefits do.
Applications, Benefits, and Risks III

75

1 Sheridan, C. (2009). Making green. Nature Biotechnology 27:1074 -1076.

2 Department of Health and Human Services. (2004). National Science Advisory Board 

for Biosecurity Charter, March 4, 2004; National Science Advisory Board for Biosecurity 

Charter—Revised, March 10, 2006. Available at: http://oba.od.nih.gov/biosecurity/PDF/

NSABB%202010%20Charter_Renewal%20.pdf. 

3 Beer, L.L., et al. (2009). Engineering algae for biohydrogen and biofuel production. Current 

Opinion in Biotechnology 20(3):264-271.

4 Savage, D.F., Way J., and P.A. Silver. (2008). Defossiling fuel: How synthetic biology can 

transform biofuel production. American Chemical Society Chemical Biology 3(1):13-16.

5 Rulkens, W. (2008). Sewage sludge as a biomass resource for the production of energy: 

Overview and assessment of the various options. Energy Fuels 22(1):9-15.

6 Synthetic Genomics, Inc. Hydrocarbon Recovery & Conversion. Available at: www.

syntheticgenomics.com/what/hydrocarbonrecovery.html. 

7

 For more information please visit: http://www.amyrisbiotech.com/.

8 BP. DuPont and BP Disclose Advanced Biofuels Partnership Targeting Multiple Butanol 

Molecules. Available at: www.bp.com/genericarticle.do?categoryId=9024973&conten

tId=7046879.

9 Gevo. Gevo Produces Isobutanol, Hydrocarbons and Jet Fuel from Cellulosic Biomass: 

Technology Milestone Validates Gevo’s Biocatalyst for Converting Cellulosic Sugars into 

Advanced Biofuels and Hydrocarbons. Available at: www.gevo.com/pr-gevo-producesisobutanol-hydrocarbons-jet-fuel-from-cellulosic-biomass.php.

10 For more information please visit: http://www.global-bioenergies.com/.

11 For more information please visit: http://www.jbei.org/. 

12 For more information please visit: http://www.ls9.com/. 

13 Bullis, K. (2007). Forget ethanol. MIT Technology Review. Available at: www.

technologyreview.com/energy/18443/. 

14 Atsumi, S., Hanai, T., and J.C. Liao. (2008). Non-fermentative pathways for synthesis of 

branched-chain higher alcohols as biofuels. Nature 451:86-90. 

15 ExxonMobil. Algae biofuels. Available at: www.exxonmobil.com/Corporate/energy_climate_

con_vehicle_algae.aspx.

16 Synthetic Genomics, Inc. Synthetic Genomics and EMRE Fact Sheet. Available at: www.

syntheticgenomics.com/media/emrefact.html. 

17 Chisti, Y. (2007). Biodiesel from microalgae. Biotechnology Advances 25(3):294-306; Solix. 

About Microalgae and Biofuels. Available at: www.solixbiofuels.com/content/technology/

about-microalgae-biofuels. 

18 For more information please visit: http://www.aurorainc.com/.

19 For more information please visit: http://www.jouleunlimited.com/about/overview.

20 For more information please visit: http://www.solazyme.com/.

21 For more information please visit: http://www.syntheticgenomics.com/.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

76

22 Demirbas, A. (2009). Biohydrogen for Future Engine Fuel Demands: Green Energy and 

Technology Virtual Series. New York and Dordrecht: Springer. Pages 105-161 at 134.

23 Clomburg, J.M., and R. Gonzales. (2010). Biofuel production in Escherichia coli: the role 

of metabolic engineering and synthetic biology. Applied Microbiology and Biotechnology

86:419-434 at 424. 

24 Beer, L.L., et al., op cit.

25 Zhang, Y.H., et al. (2007). High-yield hydrogen production from starch and water by a 

synthetic enzymatic pathway. PLoS One (Public Library of Science) 2(5):e456; Science 

and technology: Gassed up—Synthetic biology. Economist. 383(8530):104. May 24, 2007; 

Ajudua, C. (2006). Driving: Y. H. Percival Zhang’s crazy idea of the year: ‘Sugar cars’. 

Esquire. November 30, 2006. 

26 Demirbas, A., op cit., at 134.

27 Eggers, J., et al. (2009). Is biofuel policy harming biodiversity in Europe? Global Change 

Biology Bioenergy 1(1):18-34.

28 Snow, A., Professor, Department of Evolution, Ecology & Organismal Biology, Ohio State 

University. (2010). Benefits and Risks of Synthetic Biology. Presentation to the Presidential 

Commission for the Study of Bioethical Issues, July 8, 2010. Available at: www.bioethics.gov/

transcripts/synthetic-biology/070810/benefits-and-risks-of-synthetic-biology.html.

29 Callura, J.M., et al. (2010). Tracking, tuning, and terminating microbial physiology using 

synthetic riboregulators. Proceedings of the National Academy of Sciences 107(36):15898-

15903.

30 Thomas, J., Programme Manager, ETC Group. (2010). Benefits and Risks of Synthetic 

Biology. Presentation to the President’s Commission for the Study of Bioethical issues, July 8, 

2010. Available at: http://www.bioethics.gov/transcripts/synthetic-biology/070810/benefitsand-risks-of-synthetic-biology.html.

31 Dale, V.H., et al. (2010). Biofuels: Implications for land use and biodiversity. Ecological 

Society of America: Biofuels and Sustainability Report. Available at: www.esa.org/

biofuelsreports/files/ESA%20Biofuels%20Report_VH%20Dale%20et%20al.pdf. 

32 Tilman, D., Reich., P.B., and J.M. Knops. (2006). Biodiversity and ecosystem stability in a 

decade-long grassland experiment. Nature 441:629-632; Tilman, D., et al. (2001). Diversity 

and productivity in a long-term grassland experiment. Science 294(5543):843-845.

33 See Goeddel, D.V., et al. (1979). Expression in Escherichia coli of chemically synthesized 

genes for human insulin. Proceedings of the National Academy of Sciences 76(1):106–110; 

Mast, E.E., and J.W. Ward (2008). Hepatitis B vaccines. In Vaccines, S. Plotkin, W. 

Orenstein, and P. Offit (eds.). Pages 205-42; Schiller, J.T., Frazer, I.H., and Lowy, D.R. 

(2008). Human papillomavirus vaccines. In Vaccines, S. Plotkin, W. Orenstein, and P. Offit 

(eds.). Pages 243-258.

34 Rodemeyer, M. (2009). New Life, Old Bottles: Regulating First-Generation Products of 

Synthetic Biology. Washington, D.C.: Woodrow Wilson International Center for Scholars. 

Available at: www.synbioproject.org/process/assets/files/6319/nano_synbio2_electronic_final.

pdf. 
Applications, Benefits, and Risks III

77

35 Centers for Disease Control and Prevention. Malaria. Available at: www.cdc.gov/

MALARIA/. 

36 Martin V.J., et al. (2003). Engineering a mevalonate pathway in Escherichia coli for 

production of terpenoids. Nat Biotechnol. 21:796-802.

37 Amyris. Artemisinin—Anti-malarial Therapeutic. Available at: www.amyrisbiotech.com/

markets/artemisinin. 

38 Specter, M. (2009). A life of its own: Where will synthetic biology lead us? The New Yorker. 

Sept. 28, 2009. Pages 56-65, 58.

39 Synthetic Genomics. Press Release: Synthetic Genomics Inc. and J. Craig Venter Institute 

Form New Company, Synthetic Genomics Vaccines Inc. (SGVI), to Develop Next Generation 

Vaccines. October 7, 2010. Available at: www.syntheticgenomics.com/media/press/100710.

html.

40 Ibid.

41 Yang, Z., et al. (2010). Expanded genetic alphabets in the polymerase chain reaction. 

Angewandte Chemie International Edition 49(1);177-180. 

42 Benner, S.A. (2004). Understanding nucleic acids using synthetic chemistry. Accounts of 

Chemical Research 37(10):784-797.

43 Feero, E.G., Guttmacher, A.E., and F.S. Collins. (2010). Genomic medicine: An updated 

primer. New England Journal of Medicine 362:2001-2011.

44 Weiss, R., Associate Professor, Department of Biological Engineering and Department of 

Electrical Engineering and Computer Science, Massachusetts Institute of Technology. (2010). 

Synthetic Biology: What New Methods and Products are Being Developed? Presentation 

to the Presidential Commission for the Study of Bioethical Issues, September 13, 2010. 

Available at: www.bioethics.gov/transcripts/synthetic-biology/091310/synthetic-biology-whatnew-methods-and-products-are-being-developed.html. 

45 Anderson, J.C., et al. (2006). Environmentally controlled invasion of cancer cells by 

engineered bacteria. Journal of Molecular Biology 355(4):619-627.

46 Church, G.M., Professor of Genetics, Harvard Medical School. (2010). Applications of 

Synthetic Biology. Presentation to the Presidential Commission for the Study of Bioethical 

Issues, July 8, 2010. Available at: www.bioethics.gov/transcripts/synthetic-biology/070810/

applications-of-synthetic-biology.html.

47 The Joint Bioenergy Institute. About JBEI. Available at: www.jbei.org; Synthetic Genomics, 

Inc.. Agricultural Products. Available at: www.syntheticgenomics.com/what/agriculture.

html.

48 Ibid.

49 See generally Diamond v. Chakrabarty, 447 U.S. 303 (1980). 

50 Hazen, T.C., et al. (2010). Deep-sea oil plume enriches indigenous oil-degrading bacteria. 

Science 330(6001):204-208.

51 For more information please visit: http://www.etcgroup.org/en.

52 Scrinis, G. and Lyons, K., Nanotechnology and the Techno-Corporate Agri-Food Paradigm, 

in Lawrence, G., Lyons, K. and T. Wallington (eds.), Food Security, Nutrition and 

Sustainability: New Challenges, Future Options, Earthscan: London (2010).
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

78

53 See generally de Lorenzo, V. (2008). Systems biology approaches to bioremediation. Current 

Opinion in Biotechnology 19(6): 579-589; Kirby, J.R. (2010). Synthetic biology: Designer 

bacteria degrades toxin. Nature Chemical Biology 6: 398-399.

54 Cameotra, S.S., and R.S. Makkar. (2004). Recent applications of biosurfactants as biological 

and immunological molecules. Current Opinion in Microbiology 7(3):262-266.

55 Snow, A.A., et al. (2005). Genetically engineered organisms and the environment: current 

status and recommendations. Ecological Applications 15:377-404.

56 Norton, B.G., Distinguished Professor of Philosophy, School of Public Policy, Georgia 

Institute of Technology. (2010). Social Responsibility, Risk Assessment, and Ethics. 

Presentation to the Presidential Commission for the Study of Bioethical Issues, September 

13, 2010. Available at: www.bioethics.gov/transcripts/synthetic-biology/091310/socialresponsibility-risk-assessment-and-ethics.html.

57 Collins, J.J., University Professor, William F. Warren Distinguished Professor, Professor of 

Biomedical Engineering, and Co-Director, Center for BioDynamics, Boston University. 

(2010). Synthetic Biology: What New Methods and Products are Being Developed? 

Presentation to the Presidential Commission for the Study of Bioethical Issues, September 

13, 2010. Available at: www.bioethics.gov/transcripts/synthetic-biology/091310/syntheticbiology-what-new-methods-and-products-are-being-developed.html 

58 NSABB. (2010). Addressing Biosecurity Concerns Related to Synthetic Biology. Available 

at: http://oba.od.nih.gov/biosecurity/pdf/NSABB%20SynBio%20DRAFT%20ReportFINAL%20(2)_6-7-10.pdf.

59 Kodumal, S.J., et al. (2004). Total synthesis of long DNA sequences: Synthesis of 

a contiguous 32-kb polyketide synthase gene cluster. Proceedings of the National 

Academy of Sciences 101(44):15573-15578; Cello, J., Paul, A.V., and E. Wimmer. (2002). 

Chemical synthesis of poliovirus cDNA: Generation of infectious virus in the absence of 

natural template. Science 297(5583):1016-1018; Gibson, D.G., et al. (2008). Complete 

chemical synthesis, assembly, and cloning of a Mycoplasma genitalium genome. Science

319(5867):1215-1220; Tumpey, T.M., et al. (2005). Characterization of the reconstructed 

1918 Spanish influenza pandemic virus. Science 310(5745):77-80. 

60 National Center for Biotechnology Information. GenBank overview. Available at: www.ncbi.

nlm.nih.gov/genbank/. 

61 NSABB. (2006). Addressing Biosecurity Concerns Related to the Synthesis of Select Agents. 

Available at: http://oba.od.nih.gov/biosecurity/pdf/Final_NSABB_Report_on_Synthetic_

Genomics.pdf; NSABB, op cit. (2010).

62 42 C.F.R. Part 73.

63 Department of Health and Human Services. (2010). Screening Framework Guidance for 

Providers of Synthetic Double Stranded DNA. Available at: www.phe.gov/Preparedness/legal/

guidance/syndna/Pages/default.aspx. 

64 See, e.g., National Research Council, Board on Life Sciences. (2010). Sequence-Based 

Classification of Select Agents: A Brighter Line. Washington, D.C.: National Academies Press.
79

chapter 4

Oversight
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

80

A wide array of existing federal laws and regulations apply to the emerging 

field of synthetic biology. The scope of federal authority depends on 

whether the activity involves research or production; whether federal funds 

are involved; the nature of the application (e.g., to generate drugs, food, cosmetics, or fuels); and whether the product is subject to national security or 

export controls. Applicable also are local institutional, municipal, and state 

requirements, many of which focus on safety and security. 

This chapter presents a brief overview of the components of the U.S. oversight system as it relates to synthetic biology. It is intended to be a descriptive 

summary of the major regulatory laws and agencies without Commission 

recommendations or opinion (presented in Chapter 5). It focuses on the exclusive, as well as shared and overlapping, federal authorities governing research, 

development, and commercialization. Generally, synthetic biology is treated 

like other comparable areas of science and technology, and the federal government relies, in part, on local institutional-level oversight to identify and 

reduce risks. 

The government’s initial efforts at oversight of genetic engineering activities 

arose in the mid-1970s and focused, consistent with the state of the science at 

the time, on laboratory-contained research.1

 When the first genetically engineered organisms were being considered for field testing in the mid-1980s, 

the U.S. government issued a trans-agency guidance document, called “The 

Coordinated Framework,” for regulating the research and development of biotechnology products. Fundamentally, the policy calls for the government to 

regulate genetically engineered products through existing legal frameworks 

established for products developed without genetic engineering. For example, 

drugs developed by means of genetic engineering are regulated under the 

pre-market review and approval standards of the Food and Drug Administration (FDA) for new drugs.2

 The key to this policy, reflected in regulations 

across the government, is its focus on risk rather than methodology. Regulation is predicated on a risk-benefit assessment of the characteristics of the 

final product (i.e., its intrinsic characteristics and features), not the method by 

which it is made.3

 Products presenting higher risks or greater uncertainty are 

subject to higher degrees of oversight. This approach enables existing agencies 

and regulations to serve, with revisions in current rules as technology evolves, 
Oversight IV

81

as the oversight framework for emerging biotechnology. Periodic reassessment, 

ideally through an ongoing process of open public dialogue, is required as 

new knowledge and new understanding of risks emerge. The Coordinated 

Framework’s standards continue to drive the federal government’s approach 

to oversight of biotechnology, including synthetic biology.

Through this system, some oversight protections apply broadly to anyone 

working with specific organisms or creating certain environmental effects. 

Other oversight is more narrowly focused, applying exclusively, for example, 

to researchers or the research setting. Regulatory programs of the U.S. Department of Agriculture (USDA) or FDA apply case-by-case to particular goods 

like food or drugs. USDA regulations govern also the interstate movement 

of certain infectious agents, agricultural pathogens, and pests. The Environmental Protection Agency (EPA) regulates the safety of new chemicals not 

addressed by other statutes, including industrial chemicals and pesticides, and 

oversees emergency management programs for the clean up of environmental hazards. The Occupational Safety and Health Administration (OSHA), 

Department of Transportation (DOT), and Department of Commerce (DOC) 

play roles as well, setting safety standards respectively for the workplace, interstate transfer of infectious agents, and export of disease-causing organisms or 

knowledge and technologies that may pose security risks.

The National Institutes of Health (NIH) and the Centers for Disease Control 

and Prevention (CDC) help to ensure the safe and ethical conduct of synthetic 

biology research through promulgation of risk assessment and containment 

standards for laboratories and investigators. NIH specifically oversees research 

involving recombinant DNA molecules and receives advice from the NIH

Recombinant DNA Advisory Committee (RAC), a group of non-federal 

experts governed by the openness and public meeting provisions in the Federal 

Advisory Committee Act.4

 Biosafety standards and requirements of review are 

set forth in the NIH Guidelines for Recombinant DNA Research (NIH Guidelines). The NIH Guidelines require risk-based classification and containment 

for NIH-funded research involving the construction or use of recombinant 

DNA molecules, as well as organisms and viruses containing these molecules. 

Synthetic nucleic acids are addressed to the extent that recombinant methods 

are used in their assembly.5

 NIH is currently considering a proposal to amend 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

82

the NIH Guidelines to specifically include research with synthetic nucleic acids, 

regardless of whether recombinant techniques are used. NIH published this 

proposal in March 2009,6

 and, in June 2010, after consideration of public 

comment, RAC recommended that the NIH Director adopt these changes. 

CDC and NIH also promulgate a widely accepted industry standard, Biosafety 

in Microbiological and Biomedical Laboratories (BMBL), which establishes specific procedures for laboratory safety.7

CDC, USDA, the Department of Health and Human Services (DHHS), and 

the Federal Bureau of Investigation (FBI) also play specific roles in addressing concerns about biosecurity. The Federal Select Agent Program (FSAP), 

administered by CDC and USDA with the Animal and Plant Health Inspection Service (APHIS), regulates individuals and entities possessing, using, 

or transferring “select agents and toxins” within the United States.8

 Select 

Agents and toxins are pathogens or biological toxins that have been declared 

by DHHS and USDA to “have the potential to pose a severe threat to public 

health and safety.”9

 The FBI conducts the security risk assessment of individuals requesting access to Select Agents.10

Taken together, these provisions form a protective patchwork quilt of regulations and guidance for research, the workplace, environmental risks, and in 

some cases pre-market review of safety and efficacy for new products. Anticipated advances in synthetic biology, however, raise questions about the capacity 

of this system to provide effective oversight of the entire field. Concerns about 

biosafety and biosecurity, for example, are frequently voiced. Biosafety focuses 

on protecting people, plants, animals, and the environment from accidental 

exposure to a pathogen or toxin with potential adverse effects. Biosecurity 

focuses on keeping biological agents and technologies out of the hands of those 

who might misuse them. For both biosafety and biosecurity, risk assessment—

which typically extrapolates from data on known risks to characterize new 

and uncertain risks—may be particularly complicated for synthetic biology as 

novel or previously uncharacterized organisms are developed. 
Oversight IV

83

Oversight Challenges

The effective oversight of biotechnology relies on the assessment of the risks 

posed by the products generated and the process used to generate them. These 

assessments are predicated on understanding the biologic characteristics of the 

agent, its host, and the environment in which it will function.11 In synthetic 

biology, a major concern is whether the scale of manipulation, using de novo

chemical synthesis instead of conventional recombinant DNA techniques, 

raises sufficiently new levels of uncertainty about products, such as their characteristics or safety profile, to warrant new levels or forms of oversight.

The first generation of synthetic biology products is, or may likely be, relatively simple and similar to other genetically engineered products.12 In the 

short term, agents generated through synthetic biology are unlikely to raise 

novel risk assessment or risk management issues. One of the biggest challenges in the oversight of synthetic biology, however, is its capacity to create 

novel entities that are increasingly dissimilar to known agents or organisms, 

making potential risks harder to assess. As the field begins to develop more 

complex, novel, and artificial agents and products, assessing the risks posed 

will be challenging, particularly for those products with the potential to be 

released into the environment13 (see also Chapter 2 for a discussion of risks 

and benefits).

The increasing ease of access to the materials and supplies used to generate 

synthetic agents poses another unique oversight challenge. Gene and oligonucleotide sequences or parts can be commercially obtained with ease, and 

reagents and automated equipment for synthesizing nucleic acid sequences are 

available as well.14 Deviant uses of synthetic biology could therefore, at least 

theoretically, occur outside of the scope of existing oversight mechanisms. At 

this stage, however, technical challenges to creating novel organisms are such 

that it is difficult to imagine the creation of a substantial threat.

Finally, current federal oversight of biotechnology is, in some cases, limited 

to entities that are owned or funded by the federal government. This means 

that research currently being conducted using private funds is not subject to 

some federal oversight.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

84

Federal Authorities

Many federal agencies have jurisdiction over research and production activities involving synthetic biology. The Coordinated Framework organized 

lead responsibilities for oversight of intentional, beneficial uses of biotechnology, but did not compartmentalize oversight. The oversight is integrated, 

and overlap is minimized but necessarily exists as the framework is built to 

respond flexibly to changing science.

This shared oversight is described below, generally, in terms of the particular 

sectors discussed earlier in this report, but the discussion should not be understood to suggest silos or pigeonholes in the oversight system. 

Biosecurity

Several regulatory schemes and initiatives are focused on reducing biosecurity 

risks arising from biotechnology. These include FSAP, export and interstate 

transfer limitations, and the 2010 guidance for synthetic double-stranded 

DNA providers.15

Federal Select Agent Program

FSAP is administered by DHHS/CDC and USDA’s APHIS.16 Congress established FSAP to limit the possession, use, and transfer of biological agents and 

toxins, designated as “Select Agents,” that have the potential to pose a severe 

threat to public health and safety, animal and plant health, or to the safety 

of animal or plant products.17 Facilities that possess, use, or transfer Select 

Agents, including for use in synthetic biology, must be registered with FSAP, 

and individuals or entities seeking to use, transfer, or possess Select Agents 

must apply for registration and approval for these activities. Select Agents that 

are regulated by both CDC and APHIS are referred to as “overlap” agents and 

involve threats to both sectors.18

The Select Agent regulations extend both to specific agents as well as certain 

genetic elements, recombinant nucleic acids, and recombinant organisms. 

Among the regulated genetic components are: (1) nucleic acids that can 
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produce infectious forms of any of the Select Agent viruses; (2) recombinant 

nucleic acids that encode for the functional form(s) of Select Agent toxins 

if the nucleic acids (a) can be expressed in vivo or in vitro, or (b) are in a 

vector or recombinant host genome and can be expressed in vivo or in vitro; 

and (3) Select Agents and toxins that have been genetically modified.19 These 

regulations are specifically targeted to address scientific advancements such as 

synthetic biology. The nucleic acid sequence information of Select Agents is 

not regulated.20

Each individual or entity applying for registration must designate a “Responsible Official” who will ensure compliance with the regulations, including 

conducting annual inspections and overseeing proper disposition of Select 

Agents.21 Registration is granted to entities only after a risk assessment is 

performed for the individuals who have access to, or the ability to gain possession of, a Select Agent or toxin. Additionally, registration is contingent upon 

a facility inspection by FSAP, and approval of additional documents such as 

security, biosafety, and incident response plans. Any certificate of registration 

issued is only valid for three years and for a single physical location, and no 

individual may access a Select Agent at any time without approval by the 

DHHS Secretary or the APHIS Administrator.22 All records relating to Select 

Agents and toxins must be kept for three years and produced upon request.23

Any theft, loss, or release of a Select Agent must be reported to the relevant 

agency immediately and an APHIS/CDC Form 3 must be submitted within 

seven calendar days.24 Inspectors may inspect records and premises where 

Select Agent activities are carried out without prior notification.25

APHIS/CDC issued guidance recently for those who create or use synthetic 

biology and may therefore be subject to the Select Agent regulations.26 This 

guidance was partially in response to the National Science Advisory Board for 

Biosecurity’s (NSABB’s) report, Addressing Biosecurity Concerns Related to the 

Synthesis of Select Agents, which discusses the regulatory and oversight framework as it relates to synthetic genomics and Select Agents.27 Elsewhere, the FBI 

has implemented a “tripwire” initiative in partnership with the U.S. synthetic 

biology industry to report suspicious requests for genetic sequences. The FBI 

also has conducted outreach to academia and industry and do-it-yourself (DIY) 

communities to improve biosecurity for synthetic biology research and uses.28
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Export Administration Regulations

The Bureau of Industry and Security within DOC administers the Export 

Administration Regulations.29 These regulations govern the export and reexport of dual-use commodities, software, and technology from the United 

States and apply to any individual or entity seeking to export.30 Included in 

this group may be researchers collaborating with overseas colleagues, manufacturers with foreign plants, and gene synthesis providers shipping orders 

outside of the United States. Particularly relevant to the oversight of synthetic 

biology are provisions designed to restrict access to materials that have dual 

use applications (i.e., materials with both commercial applications and military or other defense applications).31

Items subject to the Bureau of Industry and Security’s licensing authority are 

listed on the Commerce Control List (CCL).32 Category 1 of the CCL contains “materials, chemicals, ‘microorganisms,’ and toxins.”33 Products are then 

classified according to “reasons for control:” (1) national security and dual 

use; (2) missile technology; (3) nuclear nonproliferation; (4) chemical and 

biological weapons; and (5) anti-terrorism, crime control, regional stability, 

short supply, United Nation sanctions, etc. 

For each controlled item, detailed licensing requirements and policies for 

screening potential recipients are imposed. Licenses are provided depending 

on the nature of the threat. The end user receiving the product must also be 

screened against lists of proscribed individuals and organizations. Relevant 

screening lists include: (1) the Entity List (parties who may trigger a license 

requirement under Export Administration Regulations), (2) the Denied 

Persons List (parties denied export privileges), (3) the Unverified List (parties 

where the Bureau of Industry and Security has been unable to identify the 

end user in prior transactions), (4) the Specially Designated Nationals List 

(parties barred by the Treasury, Office of Foreign Assets Control), (5) the 

Debarred List (parties barred by the State Department under International 

Traffic in Arms Regulations), and (6) Nonproliferation Sanctions (parties that 

have been sanctioned under various statutes).34
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Interstate Transfer Regulations

DOT sets rules for the safe and secure transportation of hazardous materials,35 which may encompass materials necessary for, or created by, synthetic 

biology. Designated hazardous materials include substances (e.g., wastes and 

pollutants) that DOT believes are capable of posing an unreasonable risk to 

health, safety, or property during transport.36 All persons transporting hazardous waste by air, rail, highway, or water must follow the regulations put out 

by the Pipeline and Hazardous Materials Safety Administration (PHMSA), 

an agency within DOT. Specified packaging, labeling, and transport requirements are imposed. For example, packages containing hazardous waste must 

be able to withstand conditions normally involved in transportation such as 

changes in pressure, temperature, and humidity, as well as vibrations and 

shocks.37 Hazardous materials must also be labeled appropriately to warn 

transporters (and possible emergency responders) of the type of material 

contained in the packaging.38 Hazardous material employees must receive 

training on PHMSA regulations so they can perform their functions safely.39

PHMSA is authorized to conduct inspections and enforce these regulations 

with civil penalties. Inspectors may send warning letters alerting transporters 

to probable violations or issue citations if they believe the alleged violation 

does not have a “direct or substantial impact on safety.”40 Any person who 

knowingly violates a requirement of these regulations may be liable for a civil 

penalty up to $55,000 per transportation or shipping violation, and up to 

$110,000 if the violation results in death, serious illness, serious injury, or 

substantial destruction of property.41 In addition, anyone who knowingly, 

willfully, or recklessly violates the regulations and releases a hazardous material may be imprisoned for up to 10 years for any resulting death or bodily 

injury.42 DOT reserves additional authority through the Federal Motor 

Carrier Safety Administration, the Federal Railroad Administration, the 

Federal Aviation Administration, and the U.S. Coast Guard.43
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Screening Framework Guidance for Providers of Synthetic 

Double-Stranded DNA

In October 2010, DHHS issued guidance for screening orders of synthetic 

double-stranded DNA. The guidance addresses the potential biosecurity 

concerns associated with the use of double-stranded DNA synthesis to reconstruct regulated pathogens and toxins. The guidance recommends “baseline 

standards...regarding the screening of orders so that they are filled in compliance with current U.S. regulations and to encourage best practices in 

addressing biosecurity concerns associated with the potential misuse of their 

products to bypass existing regulatory controls.”44 Compliance with the guidance is voluntary, but many of its specific recommendations reflect underlying 

statutory or regulatory mandates. Meeting its standards will help ensure that 

synthetic double-stranded DNA provided for use in synthetic biology will be 

in compliance with applicable federal regulations, namely the Select Agent 

regulations and the export administration regulations.45

The guidance emerged from a multi-year, public engagement process. Designed 

as “best practices,” the intention of the guidance is efficient update as new 

information and technical skills emerge. The drafters explained: “[t]he target 

audience for this guidance is the gene and genome synthesis industry, because 

the technical hurdles for de novo synthesis of Select Agents and Toxins from 

double-stranded DNA are much lower than for de novo synthesis of these 

agents from single-stranded oligonucleotides.”46 This guidance proposes a 

screening framework for “commercial providers of synthetic double-stranded 

DNA that is 200 base pairs...or greater in length to address concerns associated with the potential for misuse of their products.”47 The framework includes 

“customer screening and sequence screening, follow-up screening as necessary, 

and consultation with U.S. Government contacts, as needed.”48

Biosafety

Biosecurity and biosafety concerns frequently overlap, as do the oversight 

strategies employed to address them. In the earliest days of the genetic engineering era, oversight efforts focused on safety concerns shared by the public 

as well as scientists conducting this novel research. As the field has grown 
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and matured in the 40 years since then, the tools developed to address these 

concerns have evolved as well. 

NIH Guidelines for Research Involving Recombinant DNA Molecules

NIH established the NIH Guidelines in 1976. They were created in light of 

public concern about emerging techniques for manipulating genetic material, 

and the 1975 Asilomar Conference on Recombinant DNA in which scientists 

from academia, industry, and government came together to establish shared 

principles for containment and safety in such research. The NIH Guidelines 

specify practices for constructing and handling recombinant DNA molecules 

and organisms and viruses containing recombinant DNA molecules. Compliance with the NIH Guidelines is mandatory for investigators at institutions 

receiving NIH funds for research involving recombinant DNA49 and would 

encompass synthetic biology falling within these confines as well. With input 

from NIH RAC, NIH has modified the NIH Guidelines nearly 30 times since 

their inception in order to keep pace with advances in science and biosafety. 

Satisfying their terms is a condition of NIH funding, and they are also widely 

accepted and followed voluntarily by scientists and organizations, both public 

and private, across the research enterprise. In addition, other government 

agencies, including DOE, the Department of Veterans Affairs, and USDA, 

currently have policies in place that state that all recombinant DNA research 

conducted or funded by those agencies must comply with the NIH Guidelines.

50 Through an active process of public engagement and deliberation, they 

have become a “gold standard” that is cross-referenced by numerous resources, 

including Biosafety in Microbiological and Biomedical Laboratories (BMBL) (see 

discussion below).51

The oversight process prescribed in the NIH Guidelines begins at the local 

level. Through the work of Institutional Biosafety Committees (IBCs)—

local groups that include experts in safety and scientific practice—individual 

research plans are reviewed on a regular basis to assure that biosafety protections, including laboratory containment, are appropriate for the risk posed. 

Minimum containment measures (Biosafety Levels [BSL] 1-4) based on the 

known and unknown risks of particular experimental agents and designs 

are set forth in the NIH Guidelines, and institutions may impose additional 
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measures as deemed necessary to comply with their responsibilities under 

the guidelines.52 Many IBCs also review other forms of research that entail 

biosafety risks as part of their institutionally assigned responsibilities.53 Generally, NIH places primary responsibility on institutions to conduct oversight 

locally and non-compliance is expected to be self-reported.54

Following the advice of NIH RAC and other experts, in 2009 NIH proposed 

to clarify the scope of the NIH Guidelines to specifically cover nucleic acid 

molecules made solely by synthetic means. The proposed revisions, which are 

undergoing final review, aim to clarify the applicability of the NIH Guidelines

to research with synthetic nucleic acids and to provide principles and procedures for risk assessment and management of such research.55 NIH expects to 

finalize these amendments this year.

Private work may also interconnect with the federal oversight structure if the 

institution receives federal research funds. For example, although the work 

done by the J. Craig Venter Institute on the self-replicating synthetic genome 

was not federally funded, the Venter Institute is a major federal grant recipient, and thus, is required to adhere to the NIH Guidelines, regardless of the 

source of funding for a particular project.56 In application, this means that 

along with IBC review, the Venter Institute followed the corresponding risk 

group and biosafety measures for the organisms it was working with as prescribed by the NIH Guidelines. In addition, the Venter Institute also must 

follow regulations directed toward private workplaces, such as the OSHA 

laboratory standards described below.

Biosafety in Microbiological and Biomedical Laboratories (BMBL)

CDC and NIH developed BMBL to address the “safe handling and containment of infectious microorganisms and hazardous biological materials,”57

including those which may be used for synthetic biology. BMBL centers 

on the principles of containment and risk assessment. Containment under 

BMBL includes the “microbiological practices, safety equipment, and facility 

safeguards” required to protect people who work with biological material, 

the public, and the environment from exposure. Risk assessment allows the 

“appropriate selection of microbiological practices, safety equipment, and 
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facility safeguards” required to prevent what BMBL deems “laboratory-associated infections.”58 BMBL complements the NIH Guidelines and is broader 

in its focus. Laboratories that receive federal funding for research may be 

required to comply, if, for example, the agency requires compliance as a policy 

matter for its intramural labs, or as a term and condition of specific extramural funding. There is no federal law that requires compliance for all researchers 

regardless of funding. Thus, generally, they set a voluntary standard.59 Biosafety standards evolve as scientific knowledge progresses, and BMBL, like the 

NIH Guidelines, is intended to evolve and adapt. 

Workplace Oversight

OSHA regulates working conditions for employees in most private sector and 

federal government workplaces.60 In addition, many states (State Plan States) 

have occupational safety and health programs that have been approved by 

federal OSHA and cover public sector (state and local government) as well 

as private industry employers.61 Therefore, the regulations of OSHA or an 

equivalent State Plan State program will be relevant to most synthetic biology 

laboratories or workplaces. Under OSHA, employers must create an environment that is “free from recognized hazards that are causing or are likely 

to cause death or serious physical harm.”62 The regulations of OSHA or an 

equivalent State Plan State program lay out safety principles and precautions 

for working with and disposing of hazardous chemicals as well as toxic and 

hazardous substances. Particular attention is paid to ventilation, sanitation, 

protective equipment, machinery, and emergency procedures.63 Hazardous 

waste cleanup and first aid procedures are also imposed.64 Employers must 

evaluate the hazards of chemicals at their work place and inform employees 

about potential harms through “comprehensive hazard communication programs” including container labeling, warnings, and safety data sheets.65

The regulations of OSHA or an equivalent State Plan State program also 

protect employees who may be exposed to blood or other potentially infectious 

materials such as human bodily fluids, human unfixed tissues or organs, and 

Human Immunodeficiency Virus (HIV)-containing cells or culture medium.66

Regulations require employers exposing employees to such substances to have 

exposure control plans, delineated methods of compliance, and special protocols pertaining to the HIV and the Hepatitis B virus.67
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EPA also plays a role in workplace oversight through the Toxic Substances 

Control Act (TSCA). Under TSCA, EPA assesses risks to workers from 

exposure to new intergeneric microorganisms. EPA can impose personal protective equipment requirements and engineering control restrictions to control 

worker exposure to potentially harmful substances.68

Energy

Oversight provisions for synthetic biology in the energy sector include the 

general security and safety standards described above. They also include 

specific provisions aimed at various products, for example, biofuels, biosensors 

(for various applications), and chemical oil dispersants. These provisions may 

also apply in other sectors, such as health or agriculture as well. 

New Chemicals Including Microorganisms

EPA, under TSCA, regulates new chemicals and microorganisms, including 

those that could be derived from recombinant DNA technologies and synthetic 

biology.69 These new chemicals and new microorganisms can have uses in 

the energy sector but TSCA also addresses other industrial and commercial 

applications. Under the law, individuals or entities seeking to market or import 

new chemicals or microorganisms into the United States for commercial 

purposes must give EPA notice. New microorganisms subject to this requirement 

include “‘intergeneric’ microorganisms (including bacteria, fungi, algae, viruses, 

protozoa, etc.) formed by combining genetic material from organisms in 

different genera” and “microorganisms formed with synthetic DNA not from 

the same genus.”70 At least 90 days notice and submission of any known or 

“reasonably ascertainable” data on the intergeneric microorganism are required.71

EPA scientists then conduct a risk assessment to ensure that the microorganism 

will not present an unreasonable risk of injury to health or the environment. 

EPA reviews the proposed use(s) of the new intergeneric microorganism. It 

evaluates potential human health and environmental hazards as well as potential 

environmental, worker, and general population exposures from manufacturing, 

processing, use, and disposal. EPA may require that additional data be developed 

by the submitter to enable it to make a reasoned evaluation and may limit or 

impose restrictions depending on the findings of the risk assessment weighed 
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against the benefits of the microorganism.72 The same process applies to proposed 

commercial research and development testing of new microorganisms that are 

released into the environment. Individuals or entities seeking to conduct such 

field trials must also file 60 days notice and data with EPA.73

Certain intergeneric microorganisms are exempt from the requirement for 

full notification if the manufacturer meets specified criteria defining eligible 

microorganisms and specified use conditions (including conditions relating to 

containment, inactivation, and a number of criteria on the introduced DNA). 

The limited set of microorganisms eligible for exemption are those that have 

undergone categorical risk assessment as a species, or as a group of strains 

within a species, whereby specific features of the category and the history of 

safe use of members of the exempt category were reviewed. The criteria used, 

and list of eligible microorganisms, were subject to public comment at the 

time of proposal and had significant input from major scientific societies. This 

exemption is most applicable to the use of microorganisms to manufacture 

specialty and commodity chemicals. Also exempt are intergeneric microorganisms used for documented research in contained structures or research 

required to comply with the NIH Guidelines. The exemption for research and 

development conducted in contained structures must also address inactivation 

controls that take into account considerations such as the organism’s ability 

to survive in the environment, potential routes of release, and procedures for 

transfer of materials between facilities.74

EPA’s oversight of synthetic biology under TSCA may be limited in ways that 

pose particular challenges as synthetic biology evolves. First, the amount of 

information EPA requires to be submitted with a notification that is useful 

for assessing the risks of microorganisms is limited.75 Manufacturers need 

not test new chemicals for toxicity, pathogenicity, or other harmful effects 

before they submit a notification to EPA.76 Therefore, EPA may have limited 

information on which to base its risk assessment. However, if EPA determines 

that the available information is insufficient to permit a reasoned evaluation 

of the health and environmental effects of a new intergeneric microorganism 

and that the microorganism may pose an unreasonable risk, EPA typically 

will allow submitters to suspend the notification review period to enable such 

data to be developed. EPA can also impose restrictions on the manufacture, 
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processing, distribution in commerce, use, or disposal of a new intergeneric 

microorganism to limit exposures and releases until sufficient data are developed. However, with the potential for increasing complexity with synthetic 

biology products, predictability of the properties of microorganisms will be 

more complicated. Under TSCA, EPA does require immediate reporting by 

industry of new information on existing substances which reasonably supports the conclusion that the substance presents a substantial risk to human 

health or the environment.77

A second challenge is that the reach of the law is limited to commercial 

or commercial research and development activities.78 It is unclear that all 

potential users or developers of synthetic biology products, for example, noncommercial research efforts by DIY users, are covered. 

Human Health

FDA is the primary regulatory agency that exercises specific authority over 

drugs and devices for human health. Research activities related to such 

products are also subject to concurrent biosecurity and biosafety protections 

described above, including the NIH Guidelines, BMBL, and TSCA rules of 

EPA, as applicable.

Food and Drug Administration

New drugs and devices must satisfy FDA’s safety and effectiveness standards 

before they can be introduced into the U.S. market.79 For drugs, these standards 

require pre-market review and approval. For devices, FDA requires manufacturers to show substantial equivalence to a marketed device. FDA regulated foods, 

discussed below, and cosmetics generally reach the market without pre-market 

approval, although food additives and colorings are reviewed. 

Synthetic biology potentially may be used in some fashion in all of the products that FDA regulates. For decades in the health care area, FDA has reviewed 

and approved numerous biotechnology-derived pharmaceuticals and devices, 

including drugs and devices created from bioengineered organisms.80 It 

approved its first recombinant product, human insulin, in 1982.81 FDA has 
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issued guidance to explain its thinking about the application of its laws and 

regulations in the biotechnology sector.82 It draws no distinction between 

traditional recombinant techniques and synthetic techniques for genetic 

engineering. Gene segments “may be obtained from other organisms, or synthesized from scratch in a laboratory.”83

Before, during, and after approval for clinical testing or marketing, the manufacturer or researcher (e.g., the “sponsor”) of a product must work closely with 

FDA and provide ongoing data about safety and effectiveness.84 FDA also 

oversees pre-clinical testing, manufacturing processes, and advertising and 

promotional labeling.85 The agency imposes minimum ethical standards on 

clinical research that it oversees, including requiring the informed consent of 

research participants, safety and ethics review at the local level, and adverse 

event reporting.86

FDA retains considerable and ongoing authority to monitor safety and protect 

consumers. It may require manufacturers to submit a “risk evaluation and 

mitigation strategy,” including use of patient registries or screening tests, to 

manage known or potential risks at the time of approval or after the product 

has gone to market.87 It may withdraw approval, urge a voluntary recall, petition a court for injunction or seizure, require label changes, or issue warnings 

if so warranted.88 Severe penalties may also be imposed on violators of FDA’s 

requirements. Perpetrators can face civil penalties up to $1,000,000 per violation and criminal sanctions including up to 10 years imprisonment.89

As new technologies and applications arise, such as those that may be created 

by synthetic biology, FDA has responded and clarified its oversight. In 1985, 

it held that research using recombinant DNA technology should follow safety 

and containment provisions of the NIH Guidelines.

90 Genetically engineered 

animals, which may be used, for example, to produce pharmaceuticals or 

food for human and animal consumption, are regulated under FDA’s animal 

drug provisions because the genetically engineered construct (the modified 

DNA produced by traditional recombinant or synthetic means) itself is an 

article that meets the definition of a “drug,” something “intended to affect 

the structure or any function of the body of...animals.”91 FDA’s new animal 

drug approval process, similar to the process for human medicines, generally 
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requires pre-market review and approval. For genetically engineered animals 

of a species not traditionally consumed as food, and for which animal health 

and environmental risks are shown to be low, FDA may exercise “enforcement discretion” and decline to require pre-market approval, as it did with 

aquarium fish engineered to glow in the dark.92

Agriculture, Food, and Environment

Many of the laws and regulations discussed above apply to research and commercial activities involving synthetic biology in the agriculture, food, and 

environment sectors. Under TSCA, for example, EPA undertakes prior review 

of new chemical substances, like biofertilizers, and other environmental 

applications of biotechnology, like bioremediation and mineral extraction. In 

addition, algae developed for chemical production other than energy, when 

grown in the open, would be construed as a potential environmental release 

and receive TSCA oversight. Major oversight programs involving plant and 

animal pests and pesticides are administered concurrently by USDA and EPA 

respectively. FDA oversees certain food safety and production activities. 

Environmental Impact

Under the National Environmental Policy Act (NEPA), all federal agencies 

undertaking major action must take into account the impact their action 

may have on the environment.93 Before reaching a final decision on any proposed action that may have a significant effect, the government must evaluate, 

through a public process, the anticipated environmental impact of the action 

along with any reasonable alternatives.94 Public comment is requested at 

several points in this process.95 Pursuant to NEPA and the Clean Air Act, 

EPA reviews all “environmental impact statements,” and makes its comments 

available to the public. EPA also reviews selected environmental assessments.96

NEPA does not require agencies to select the alternative with the least environmental impact.97 The NEPA process, however, helps ensure that agencies 

are making informed decisions, responding to public concern, and taking into 

account mitigation of environmental impact. Typically used in situations such 

as new construction or major changes in federal land use, NEPA requirements 

may also be applied to laboratory research and scientific advancements. While 
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the drafting of an environmental impact statement is time consuming, the 

NEPA process adds an important layer of protection to uncertain or controversial decisions surrounding synthetic biology.

Plant and Animal Pests

USDA’s APHIS is responsible for regulating the introduction (importation, 

interstate movement, and environmental release) of genetically engineered 

organisms that are known to, or could, pose a plant pest risk.98 Genetically 

engineered organisms are considered to be “regulated articles” if the donor 

organism, recipient organism, vector, or vector agent used in their creation is 

known to be a plant pest, the plant pest status of that organism is not known, 

or there is a reason to believe that one of these organisms may be a plant 

pest, and therefore may encapsulate synthetically created organisms.99 APHIS 

derives the authority to regulate the introduction of genetically engineered 

organisms from the Plant Protection Act of 2000.100 This act defines a plant 

pest as a living stage of an organism (such as an insect, bacterium, fungus, 

or virus) that “may directly or indirectly injure, cause damage to, or cause 

disease in any plant or plant product.”101 The regulations apply to genetically 

engineered microorganisms, insects, and other traditional types of plant pests 

and to any genetically engineered plants if plant pest organisms (bacterial and 

viral plant pathogens) are the donor organisms and vector agents are used in 

the creation of these genetically engineered plants.102

APHIS currently uses a permit and notification system to authorize the 

introduction of regulated articles; all regulated articles are eligible for the 

permitting procedure, and certain regulated genetically engineered plants 

are eligible for the notification procedure.103 The notification procedure is an 

administratively streamlined process. Currently, most regulated genetically 

engineered plants are introduced under notification, and approximately 10 

percent of APHIS authorizations are done under the permitting procedure. A 

permit may be withdrawn where any permit condition established by APHIS 

is violated.104
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In making a regulatory determination for a permit or notification for a 

regulated article, APHIS bases its determination on whether the actions 

under notification or permit are unlikely to result in the introduction or 

dissemination of a plant pest. This determination takes into account various 

risk factors, including, among other things, a low risk that the genetically 

engineered organism or its progeny can persist, reproduce, or establish 

without human assistance. 

A person may petition the agency to evaluate submitted data and assess 

whether a particular regulated article is unlikely to pose a plant pest risk, 

and, therefore, should no longer be subject to APHIS regulations for genetically engineered organisms.105 If, based on submitted information, the agency 

concludes that the article is unlikely to pose a plant pest risk, the agency may 

make a determination to approve the petition and confer non-regulated status 

on the regulated article. Thereafter, APHIS would no longer require permits 

or notification for the introduction of this genetically engineered organism.106

For animals and genetically engineered animal products, APHIS controls 

import, export, and interstate movement through a similar licensing process. 

To apply for a product license, test reports and research data must be submitted that establish the purity, safety, potency, and efficacy of the product. 

Product labels, including all claims made on them and in advertisements, 

must also be submitted.107 Facility licenses are approved once a USDA administrator has approved the conditions of the production facility and production 

methods and verified that the applicant is sufficiently qualified.108 Researchers 

and sponsors must show that their experimental product will not contaminate any current products and will be carefully disposed of and controlled.109

Authorization to ship experimental products is allowed only in very strict 

circumstances and to limited destinations.110

No products may be imported into the United States without a permit.111

Biological product permits can be issued for research and evaluation, distribution and sale, and transit shipment.112 Strict requirements for containment, 

disease profile of the shipping country, qualifications of the recipient, and 

safety of the product, among others, are applied during the application 

process.113 Ongoing inspection of production facilities and products may 
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be undertaken.114 Manufacturers and importers must keep detailed records 

of the production process, testing results, and inventory and disposition of 

the product.115 These detailed APHIS regulations would therefore add many 

helpful pieces to the patchwork quilt of protections for different types and 

uses of synthetic biology.

Pesticides

Before pesticides can be commercialized or used in the United States, they 

must meet specific health and safety standards under the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA).116 FIFRA requires EPA to determine that a pesticide will not pose an unreasonable risk of harm to human 

health or the environment.117 Both naturally occurring and genetically engineered microorganisms and plants, including those created by synthetic 

biology, are regulated in this way. 

EPA’s pre-market approval and post-market adverse event reporting requirements rely on careful scientific evaluation. The agency must determine “with 

a reasonable certainty” that “no harm to human health” and no “unreasonable 

risks to the environment” will occur when the product is used as intended and 

according to label directions.118 EPA requires applicants to perform various 

tests and submit comprehensive data before approval.119 EPA also sets “tolerances,” meaning maximum pesticide residue levels, for the amount of the 

pesticide that can remain in or on foods or feed crops.120

For research on pesticides, EPA’s oversight is more limited. It does not require 

pre-approval for laboratory or contained-setting research.121 Field testing, 

which is a prerequisite for commercial marketing approval, usually requires 

EPA pre-clearance through an experimental use permit or notification.122

Experimental use permits are granted if, in EPA’s view, the experimental use 

will not yield unreasonable adverse effects on the environment. As with marketing approval, applicants must submit detailed information including safety 

and pre-field testing data, to support their permit request. 

States also regulate pesticides under FIFRA and applicable state laws. Some states 

impose more restrictive requirements and others defer to EPA’s oversight.123
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Genetically Engineered Foods

All genetically engineered animals, regardless of whether they are intended 

for food use, are within FDA’s jurisdiction, as explained above, because 

the recombinant DNA constructs that alter the animal’s structure or function meet the definition of new animal drugs. FDA oversees the safety and 

effectiveness of these animals through its pre-market review and approval 

processes. Applicable law does not require pre-market clearance for “food,” 

whether derived from plant or animal. However, FDA requires evidence that 

food additives are safe at their intended level of use before they may be added, 

which is relevant for the products of genetic engineering.124

FDA has two main authorities over foods. First, it has post-market authority 

to seize foods that pose a risk to public health.125 Second, it may regulate as 

food additives the substances (e.g., enzymes) added to plants. For example, 

in 1994 the agency reviewed a genetically engineered tomato with improved 

ripening qualities and regulated a gene product added to the tomato as a 

food additive.126 Where a substance is not “generally recognized as safe” or 

otherwise exempt, FDA must review and approve the use of the additive 

before marketing, regardless of the technique used to add it to food.127

FDA is authorized to assure that the foods under its purview bear labels that 

are truthful and not misleading.128 For foods from genetically engineered 

plants, FDA policy expressly indicates that name changes are appropriate only 

if “the resulting GE [genetically engineered] food product” is “materially different from its traditional counterpart,” meaning that “the GE food product 

differs in nutritional quality, taste, etc.”129 In the tomato example cited above, 

FDA found use of the traditional name “tomato” appropriate because the 

genetically engineered product did not meaningfully differ in chemical composition from a traditional tomato. In contrast, FDA did require a special 

label for oil derived from a genetically engineered soybean plant because it 

contained significantly higher amounts of oleic acid than traditional soybean 

oil.130 Production methodology (i.e., whether a product is produced through 

biotechnology or through conventional breeding) is not considered “material” 

information, and therefore such information is not required to be disclosed on 

the food label.131 FDA follows this same standard for foods from genetically 
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engineered animals, although no genetically engineered animals have been 

approved for food at this time. 

Environmental Impact and Clean Up

At the far end of the oversight scheme, particularly at this early stage of synthetic biology research and development, are remediation programs. EPA 

oversees programs for prevention and emergency management of chemical accidents;132 oil pollution prevention and discharge;133 and emergency 

planning and notification.134 Under EPA, the Office of Solid Waste and Emergency Response also has both emergency and long-term clean up programs 

under the Comprehensive Environmental Response, Compensation, and 

Liability Act, as well as the Resource Conservation and Recovery Act. The 

scientific risk assessment and response strategies employed in these operations 

are likely to evolve as the field of synthetic biology itself evolves. 

Summary

Multiple federal departments and agencies have significant oversight responsibilities for synthetic biology. The scope of these authorities extends from the 

laboratory to the field, the environment, the workplace, and the market. Some 

agencies impose specific safety conditions on research funded with federal 

dollars or at institutions that receive federal funds. Others reach all research, 

development, and commercial activities that raise specific threats or risks of 

harm. Generally, there is at least one federal agency—NIH, CDC, FDA, 

USDA, OSHA, DOT, DOC, or EPA—with specific oversight responsibility 

for a proposed application and frequently there is overlapping jurisdiction. 

Where prior experience or the character of the activity warrants heightened 

scrutiny, like drug and device development or pesticide use, pre-market 

review or approval is usually required. Genetically engineered animals require 

approval by FDA prior to entering into commerce.

This patchwork quilt of measures is built on long-standing practices that have 

adapted to new technologies over time. Risk assessment in this field may be 

particularly challenging and require both new techniques and new standards. 

Further adaptation and restructuring may be required as the applications 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

102

of synthetic biology grow and their consequences are better understood. As 

elaborated on in Chapter 5, the Commission’s overview has indicated that 

the government should undertake a more comprehensive review, through a 

central body such as the Executive Office of the President, to assure that the 

existing patchwork quilt is indeed affording the U.S. public and the environment with adequate protections as the field of synthetic biology advances.
Oversight IV

103

1 Patterson, A., Acting Associate Director for Science Policy, NIH. (2010). Federal Oversight 

of Synthetic Biology Research. Presentation to the President’s Commission for the Study of 

Bioethical Issues, July 9, 2010. Available at: www.bioethics.gov/documents/synthetic-biology/

Federal-Oversight-of-Synthetic-Biology-Research.ppt.

2 Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23302 (June 26, 

1986).

3 Patterson, A., op cit.

4 Office of Biotechnology Activities. About Recombinant DNA Advisory Committee (RAC). 

Available at: http://oba.od.nih.gov/rdna_rac/rac_about.html. 

5 DHHS/NIH. (2009). NIH Guidelines for Recombinant DNA Molecules. Available at: http://

oba.od.nih.gov/rdna/nih_guidelines_oba.html.

6 Recombinant DNA Research: Proposed Actions Under the NIH Guidelines for Research 

Involving Recombinant DNA Molecules (NIH Guidelines), 74 Fed. Reg. 9411-9421 (Mar. 4, 

2009).

7 DHHS. (2009). Biosafety in Microbiological and Biomedical Laboratories, 5th Edition. 

Available at: www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf.

8 APHIS/CDC. (2010). Select Agents and Toxins. Available at: www.selectagents.gov/

Select%20Agents%20and%20Toxins.html.

9 42 C.F.R. § 73.3; 9 C.F.R. § 121.3; 7 C.F.R. § 331.3.

10 APHIS/CDC. (2010). Security Risk Assessments: Overview. Available at: www.selectagents.

gov/sra.html.

11 Patterson, A., op cit.

12 Rodemeyer, M., Lecturer, Department of Science, Technology and Society, School of 

Engineering and Applied Science, University of Virginia. (2010). Risks and Regulation of 

Products of Synthetic Biology Products. Presentation to the President’s Commission for 

the Study of Bioethical Issues, July 9, 2010. Available at: www.bioethics.gov/transcripts/

synthetic-biology/070910/federal-oversight-of-synthetic-biology.html; Rodemeyer, M. 

(2009). New Life, Old Bottles: Regulating First-Generation Products of Synthetic Biology. 

Report for the Woodrow Wilson International Center for Scholars Synthetic Biology Project/

Syn Bio 2. Page 40. Available at: www.synbioproject.org/library/publications/archive/

synbio2/.

13 Ibid.

14 Patterson, A., op cit. For example, in 2002 virologist Eckard Wimmer announced that his 

team had created live poliovirus “from scratch” using DNA they ordered by mail, and a viral 

genome map on the internet. Ball, P. (2004) Starting from scratch. Nature 431:624-626.

15 Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA, 75 Fed. 

Reg. 62820 (Oct. 13, 2010).

16 APHIS/CDC. Applicability of the Select Agent Regulations to Issues of Synthetic Genomics. 

Available at: www.selectagents.gov/SyntheticGenomics.html.

17 7 C.F.R. Part 331; 9 C.F.R. Part 121; 42 C.F.R. Part 73.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

104

18 7 U.S.C. § 8411.

19 7 C.F.R. § 331.3(c); 9 C.F.R. §§ 121.3(c), 121.4(c); 42 C.F.R. §§ 73.3(c), 73.4(c).

20 APHIS/CDC. Applicability of the Select Agent Regulations to Issues of Synthetic Genomics, 

op cit.

21 7 C.F.R. § 331.9; 9 C.F.R. § 121.9; 42 C.F.R. § 73.9.

22 7 C.F.R. § 331.7; 9 C.F.R. § 121.7; 42 C.F.R. § 73.7.

23 7 C.F.R. § 331.17; 9 C.F.R. § 121.17; 42 C.F.R. § 73.17.

24 7 C.F.R. § 331.19; 9 C.F.R. § 121.19; 42 C.F.R. § 73.19.

25 7 C.F.R. § 331.18; 9 C.F.R. § 121.18; 42 C.F.R. § 73.18.

26 APHIS/CDC. Applicability of the Select Agent Regulations to Issues of Synthetic Genomics, 

op cit.

27 NSABB. (2006). Addressing Biosecurity Concerns Relating to the Synthesis of Select Agents. 

Available at: http://oba.od.nih.gov/biosecurity/pdf/Final_NSABB_Report_on_Synthetic_

Genomics.pdf.

28 You, E.H., Supervisory Special Agent, Bioterrorism Program, Countermeasures Unit 

1, FBI Weapons of Mass Destruction Directorate. (2010). FBI Perspective: Addressing 

Synthetic Biology and Biosecurity. Presentation to the President’s Commission for the Study 

of Bioethical Issues, July 9, 2010. Available at: www.bioethics.gov/transcripts/syntheticbiology/070910/federal-oversight-of-synthetic-biology.html. 

29 Bureau of Industry and Security. Policies and Regulations. Available at: www.bis.doc.gov/

policiesandregulations/index.htm.

30 Excepted are items of national security or foreign policy significance that are exclusively 

controlled by enumerated other agencies. 15 C.F.R. § 734.3.

31 15 C.F.R. § 730.3.

32 15 C.F.R. § 738.1.

33 15 C.F.R. § 738.2(a).

34 Bureau of Industry and Security. Lists to Check. Available at: www.bis.doc.gov/

complianceandenforcement/liststocheck.htm. 

35 49 U.S.C. § 5103.

36 49 C.F.R. § 171.8.

37 49 C.F.R. § 173.24.

38 49 C.F.R. Part 172, Subpart E.

39 49 C.F.R. Part 172, Subpart H.

40 49 C.F.R. §§ 107.309-107.310.

41 49 C.F.R. § 107.329.

42 49 C.F.R. § 107.333.

43 49 C.F.R. §§ 174-177.
Oversight IV

105

44 Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA (2010), 

op cit., at 62820.

45 Ibid.

46 Screening Framework Guidance for Synthetic Double-Stranded DNA Providers, 74 Fed. Reg. 

62319, 62319 (Nov. 27, 2009).

47 Ibid.

48 Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA (2010), 

op cit.

49 DHHS/NIH, op cit. at Sec. 1-C.

50 Fauci, A.S., Director, National Institute of Allergy and Infectious Diseases. (2010). Advances 

in Synthetic Biology: Significance and Implications. Testimony before the Committee on 

Energy and Commerce of the U.S. House of Representatives, May 27, 2010. Available at: 

http://energycommerce.house.gov/documents/20100527/Fauci.Testimony.05.27.2010.pdf. 

51 DHHS, op cit.

52 Ibid.

53 Office of Biotechnology Activities. (2009). Frequently Asked Questions (FAQs) of Interest 

to IBCs. Available at: http://oba.od.nih.gov/oba/ibc/FAQs/IBC_Frequently_Asked_

Questions7.24.09.pdf. 

54 DHHS, op cit.

55 NIH Guidelines, op cit.

56 Venter, J.C., Founder and President, JCVI. (2010). Applications of Synthetic Biology. 

Presentation to the President’s Commission for the Study of Bioethical Issues, July 8, 2010. 

Available at: http://www.bioethics.gov/transcripts/synthetic-biology/070810/applications-ofsynthetic-biology.html.

57 DHHS, op cit.

58 Ibid.

59 Congressional Research Service. (2009). Oversight of High-Containment Biological 

Laboratories: Issues for Congress. Pages 8-9. Available at: www.fas.org/sgp/crs/terror/R40418.

pdf.

60 29 U.S.C. § 651.

61 OSHA. State Occupational Safety and Health Plans. Available at: http://www.osha.gov/dcsp/

osp/index.html. 

62 29 U.S.C. § 654.

63 29 C.F.R. Part 1910.

64 29 C.F.R. § 1910.120.

65 29 C.F.R § 1910.1200.

66 29 C.F.R. § 1910.1030(a)-(b).
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

106

67 29 C.F.R. § 1910.1030(c)-(f).

68 40 C.F.R. Part 721.

69 Willis, J., Director, Chemical Control Division, Office of Pollution Prevention and Toxics, 

EPA. (2010). Comments submitted to the Presidential Commission for the Study of 

Bioethical Issues, July 19, 2010.

70 40 C.F.R. § 725; EPA. (2010). Microbial Products of Biotechnology: Summary of Regulations 

Under the Toxic Substances Control Act (Fact Sheet). Available at: www.epa.gov/biotech_

rule/pubs/fs-001.htm.

71 15 U.S.C. § 2604; 40 C.F.R. Part 725.

72 40 C.F.R. Part 725.

73 40 C.F.R. § 725.250.

74 40 C.F.R. Part 725.

75 15 U.S.C. § 2607(a)(2).

76 Rodemeyer, M. (2009), op cit.

77 15 U.S.C. § 2607(e).

78 Rodemeyer, M. (2009), op cit.

79 21 U.S.C. § 355; 21 C.F.R. Part 314; 21 U.S.C § 360(k); 21 C.F.R. Part 807, Subpart 

E; 21 U.S.C. § 360e; 21 C.F.R Part 814; FDA. (2010). How Drugs Are Developed 

and Approved. Available at: www.fda.gov/Drugs/DevelopmentApprovalProcess/

HowDrugsareDevelopedandApproved/default.htm; FDA. (2009). Overview of Device 

Regulation. Available at: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/

Overview/default.htm.

80 FDA. (2009). FDA News Release: FDA Approves Orphan Drug ATryn to Treat Rare Clotting 

Disorder. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/

ucml09074.htm; FDA. (2007). Guidance for Industry and FDA Staff: Class II Special 

Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced 

by Recombinant DNA Technology. Available at: www.fda.gov/downloads/MedicalDevices/

DeviceRegulationandGuidance/GuidanceDocuments/ucm071352.pdf. 

81 Junod, S.W. (2007). Celebrating a Milestone: FDA’s Approval of First Genetically-Engineered 

Product. Available at: www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/

SelectionsFromFDLIUpdateSeriesonFDAHistory/ucm081964.htm. 
Oversight IV

107

82 FDA. (1997). Guidance for Industry: ICH S6 Preclinical Safety Evaluation of 

Biotechnology-Derived Pharmaceuticals. Available at: www.fda.gov/downloads/Drugs/

GuidancecomplianceRegulatoryInformation/Guidances/ucm074957.pdf; FDA. 

(2009). Draft Addendum to ICH S6: Preclinical Safety Evaluation of BiotechnologyDerived Pharmaceuticals S6(R1). Available at: www.fda.gov/downloads/Drugs/

GuidanceComplianceRegulatoryInformation/Guidances/UCM194490.pdf; FDA. 

(2002). Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived 

from Bioengineered Plants for Use in Humans and Animals. Available at: www.fda.gov/

downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124811.

pdf; FDA. (2009). Guidance for Industry: Regulation of Genetically Engineered Animals 

Containing Heritable Recombinant DNA Constructs. Available at: www.fda.gov/downloads/

AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM113903.

pdf. 

83 FDA. (2009). Animal and Veterinary General Q & A: What Is Genetic Engineering?

Available at: www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/

GeneticEngineering/GeneticallyEngineeredAnimals/ucm113605.htm.

84 21 C.F.R. Part 312; 21 C.F.R Part 314; 21 C.F.R. § 314.80; 21 C.F.R. § 314.81.

85 21 C.F.R. Part 58; 21 C.F.R. Parts 210 and 211; 21 C.F.R. Parts 201-203.

86 21 C.F.R Part 50; 21 C.F.R. Part 56; 21 C.F.R. § 312.32; 21 C.F.R. § 812.150.

87 FDA. (2009). Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation 

and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications. 

Available at: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/

Guidances/UCM184128.pdf.

88 21 C.F.R. § 314.150; 21 C.F.R. § 814.46; 21 C.F.R. Part 7, Subpart C; 21 U.S.C. § 332; 21 

U.S.C. § 334.

89 21 U.S.C. § 333.

90 FDA. (1985). Draft: Points to Consider in the Production and Testing of New Drugs 

and Biologicals Produced by Recombinant DNA Technology. Available at: www.fda.

gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/

OtherRecommendationsforManufacturers/UCM062750.pdf. 

91 FDA. (2010). Veterinary Medicine Advisory Committee Briefing Packet: AquAdvantage 

Salmon. Page 1. Available at: www.fda.gov/downloads/AdvisoryCommittees/

CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM224762.pdf.

92 FDA. (2010). Regulation of Genetically Engineered Animals. Available at: www.fda.

gov/downloads/ForConsumers/ConsumerUpdates/ucm048122.pdf; Int’l Ctr. for Tech. 

Assessment v. Thompson, 421 F. Supp. 2d 1 (D.D.C. 2006); Int’l Ctr. for Tech. Assessment v. 

Leavitt, 468 F. Supp. 2d 200 (D.D.C. 2007).

93 42 U.S.C. § 4321 et seq.; Council on Environmental Quality, Executive Office of the 

President. (2007). A Citizen’s Guide to the NEPA: Having Your Voice Heard. Page 13. 

Available at: http://ceq.hss.doe.gov/nepa/Citizens_Guide_Dec07.pdf.

94 Ibid, at 5, 11.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

108

95 Ibid, at 13-14.

96 Ibid, at 6.

97 Ibid, at 5.

98 See generally, APHIS. (2007). Biotechnology. Available at: www.aphis.usda.gov/

biotechnology/index.shtml.

99 7 C.F.R. § 340.1.

100 7 U.S.C. §§ 7701-7736.

101 7 U.S.C. § 7702(14).

102 7 C.F.R. Part 340.

103 APHIS. (2007). Permits, Notifications, and Petitions. Available at: www.aphis.usda.gov/

biotechnology/submissions.shtml; 7 C.F.R. § 340.3; 7 C.F.R. § 340.4.

104 7 C.F.R. § 340.4(g). 

105 7 C.F.R. § 340.6.

106 APHIS. (2010). Petitions. Available at: www.aphis.usda.gov/biotechnology/petitions.shtml. 

107 9 C.F.R. § 102.3(b).

108 9 C.F.R. § 102.4.

109 9 C.F.R. § 103.2.

110 9 C.F.R. § 103.3.

111 9 C.F.R. § 104.1(a).

112 9 C.F.R. § 104.2(a).

113 9 C.F.R. § 104.2.

114 9 C.F.R. Part 115.

115 9 C.F.R. Part 116.

116 7 U.S.C. § 136 et seq.

117 7 U.S.C. § 136a(c)(5); 7 U.S.C. § 136(bb). See also EPA. (2010). Regulating Pesticides. 

Available at: www.epa.gov/pesticides/regulating/index.htm.

118 EPA. (2010). Evaluating New Pesticides and Uses. Available at: www.epa.gov/pesticides/

regulating/index.htm#eval.

119 40 C.F.R. Parts 152, 158, and 161; EPA. (2010). Pesticide Registration Program. Available at: 

www.epa.gov/pesticides/factsheets/registration.htm#process.

120 21 U.S.C. § 346a; EPA. (2010). Pesticide Tolerances. Available at: www.epa.gov/pesticides/

regulating/tolerances.htm. 

121 40 C.F.R. § 172.3(b)(1).

122 7 U.S.C. § 136c; 40 C.F.R. Part 172, Subpart A; 40 C.F.R. § 172.45.
Oversight IV

109

123 American Association of Pesticide Control Officials. Available at: http://aapco.ceris.purdue.

edu/index.html.

124 21 U.S.C. § 348; International Food Information Council and FDA. (2010). Food 

Ingredients and Colors. Available at: www.fda.gov/Food/FoodIngredientsPackaging/

ucm094211.htm; FDA. (1992). Statement of Policy: Foods Derived from New Plant Varieties: 

Guidance to Industry for Foods Derived from New Plant Varieties, 57 Fed. Reg. 22984 (May 

29, 1992).

125 21 U.S.C § 334; 21 U.S.C. § 342.

126 21 C.F.R. § 173.170; 21 C.F.R. § 573.130; FDA. (1994). Agency Summary Memorandum Re: 

Consultation with Calgene, Inc., Concerning FLAVR SAVRTM Tomatoes. Available at: www.

fda.gov/Food/Biotechnology/Submissions/ucm225043.htm#out38.

127 Maryanski, J.H., Biotechnology Coordinator, Center for Food Safety and Applied Nutrition, 

FDA. (1999). Genetically Engineered Foods. Statement to the Subcommittee on Basic 

Research, House Committee on Science, October 19, 1999. Available at: www.fda.gov/

newsevents/testimony/ucm115032.htm. 

128 21 U.S.C. § 343(a).

129 FDA. (2010). Background Document: Public Hearing on the Labeling of Food Made 

from the AquAdvantage Salmon, Page 4. Available at: www.fda.gov/downloads/

Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/TopicSpecificLabelingInformation/UCM223913.pdf; FDA Statement of Policy, op cit.; FDA. 

(2001). Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have 

or Have Not Been Developed Using Bioengineering. Available at: www.fda.gov/food/

guidancecomplianceregulatoryinformation/guidancedocuments/foodlabelingnutrition/

ucm059098.htm. 

130 FDA Background Document, op cit.

131 Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166, 178-179 (D.D.C. 2000).

132 40 C.F.R. Part 68.

133 40 C.F.R. Part 112; 40 C.F.R. Part 110.

134 40 C.F.R. Part 68; 40 C.F.R. Part 112; 40 C.F.R. Part 110; 40 C.F.R Part 355.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

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111

chapter 5

Analysis and Recommendations
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

112

The President asked the Commission to recommend how the developing 

field of synthetic biology and related technologies can maximize public 

benefits, minimize risks, and observe appropriate ethical boundaries. A framework of basic ethical principles can provide guidance in the assessment of an 

emerging technology such as synthetic biology. In this case, as described in 

Chapter 1, five principles are identified that are most relevant to assessing 

ethical considerations related to synthetic biology and other emerging technologies: 

1. Public Beneficence

2. Responsible Stewardship

3. Intellectual Freedom and Responsibility

4. Democratic Deliberation

5. Justice and Fairness 

The Commission relied on these principles to conduct its analyses and build 

its recommendations, as presented in this chapter. It is the Commission’s hope 

that these principles will be applicable not only to synthetic biology, but also 

to assessing other emerging technologies. 
Analysis and Recommendations V

113

Public Beneficence

The ideal of public beneficence is to act to maximize public benefits and minimize 

public harm. This principle encompasses the duty of a society and its government to 

promote individual activities and institutional practices, including scientific and 

biomedical research, that have great potential to improve the public’s well-being. In 

the case of emerging technologies like synthetic biology, this improvement may be by 

means of providing improved or more widely available forms of medical and health 

care, food, shelter, transportation, clothing, and eco-friendly fuel, along with other 

means of improving people’s lives. Scientific and technological discovery often have 

the added potential of increasing economic opportunities, which also redound to 

the public good.

This section focuses on how society and its members—individually and collectively—can provide an environment for synthetic biology to flourish for 

the benefit of as many people and communities as possible. The Commission 

observed during its deliberations considerable enthusiasm for the field among 

scientists, industry representatives, and the public. The anticipated benefits 

portend dramatic potential improvements in energy production, the economy, 

health care, and other areas that would enhance public welfare. The development of strategies that will allow the field to continue to grow in ways that 

offer the greatest potential net benefit to individuals and communities, both in 

the United States and worldwide, should be a high priority for public policy.

Promoting Public Well-Being and Prioritizing the Public Good

Citizens and their representatives have good reason to be engaged observers in 

the development of synthetic biology, particularly in light of the potentially 

transformative benefits to society of potential uses. Chapter 3 presented 

current examples of synthetic biology applied in research and development 

programs designed to benefit humankind. Environmentally friendly biofuels 

and affordable antimalarial drugs are among the near-term products of 

synthetic biology already receiving significant attention. These are important 

current examples of how advances in synthetic biology may deliver widespread 

benefits that promote social welfare. Continued investment in this field 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

114

should be directed to these types of applications and others that offer similarly 

expansive opportunities to address serious problems that affect our collective 

well-being. 

The Commission’s deliberations called attention to the diversity of interests 

and practitioners participating in the synthetic biology community. Despite 

their range of disciplinary backgrounds, nationalities, and institutions, 

synthetic biologists appear united in contributing their expertise to the development of novel products that address global needs. Distinguishing between 

academic, public, and commercial research in synthetic biology is extremely 

difficult, as many researchers are active contributors in each domain. In many 

ways, drawing this distinction is unnecessary. The organizational home of an 

individual practitioner may not limit his or her ability to work with others to 

accomplish shared research goals. 

This intermingling of academic and commercial research—both basic and 

applied—provides fertile ground for innovation.1

 The development of semisynthetic artemisinin, an antimalarial drug, is one example that demonstrates 

how academic, public, non-profit, and industry interests have come together 

to promote global well-being. In this case, researchers at a public university 

interested in exploring synthetic biology identified the production of artemisinin, a treatment for malaria, as potentially improvable using synthetic biology 

techniques. An estimated one million people, primarily children under the age 

of 5 years, die annually from malaria.2

 Researchers began with public dollars 

and expanded their work in partnership with a private foundation. The results 

are being commercialized by a for-profit pharmaceutical manufacturer, and a 

non-profit foundation is planning for eventual distribution. While the story is 

not over and initial drug production remains in process, the model shows how 

collaboration between academia, the private sector, and industry can use synthetic biology to address significant societal problems.

The artemisinin story illustrates one way that a diverse group of interests and 

funding sources—both public and private—can collaborate on research and 

development activities involving synthetic biology. As with many emerging 

technologies at an early stage, however, public information about the amount 

of public and private investment in this field is minimal.3
Analysis and Recommendations V

115

Public funding of research can bring an enhanced measure of focus, oversight, 

and accountability to any emerging technology. Absent national security 

protections, government-funded research in the United States is publicly disclosed. Public funding also promotes transparency and accountability that 

might not exist in purely private efforts.

Private funds may not be widely available for research into risk assessment 

practices or the ethical and social safeguards that aim to maximize public 

benefit while minimizing the risks of new technologies like synthetic biology. 

In synthetic biology, there are some notable exceptions of private funding for 

efforts to examine ethical, legal, and social issues, including commendable 

activities supported directly by the J. Craig Venter Institute and the Alfred P. 

Sloan Foundation.4

 The scope and impact of these efforts are, however, generally quite limited. In order to understand the possibilities and moral limits of 

synthetic biology public funding may be necessary to augment such efforts. 

The products of this work are critical to ongoing efforts to evaluate safety 

and to promote public acceptance of this emerging field. Research exploring 

the normative and conceptual issues related to these topics can be a valuable 

complement to the empirical, quantitative, or qualitative work that typically 

receives greater support from public funding sources.

To promote public engagement and assure needed transparency regarding federal 

efforts in the field of synthetic biology, the government should review and make 

public findings regarding the scope of its research funding at this time.

Recommendation 1: Public Funding Review and Disclosure

Through a central body such as the Executive Office of the President, the 

federal government should undertake a coordinated evaluation of current 

public funding for synthetic biology activities, including funding for research 

on techniques for risk assessment and risk reduction, and for the study of 

ethical and social issues raised by synthetic biology. This review should be 

completed within 18 months and the results made public. 

The evaluation recommended here would ensure effective use of public funds, 

promote transparency, develop priorities, and avoid redundancy. This recommendation and the examples below align with the Commission’s interest in 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

116

justice and fairness. It aims for the potential benefits of synthetic biology to 

extend to as many individuals and communities as is reasonably possible, 

addressing this country and the world’s most urgent and compelling needs 

(see pp. 161-166). Public funding can be an important tool in realizing these 

goals and doing so in ways that are sensitive to ethical and safety concerns.

Most potential products of synthetic biology are in very early stages of development. Basic research is critical to further expansion of this science and its 

effective translation into useful products. Basic research—work that focuses 

on enhancing our understanding of fundamental principles of science and the 

natural world—is also important to the growth of the field. Direct commercial applications are not typically the intended outcomes of basic research, yet 

this work can also be extremely valuable to society. A commitment to basic 

research reflects a belief that knowledge is itself a public good.

More practically, scientific fields invariably develop in unanticipated ways. 

The aggressive pursuit of fundamental research generally results in a broader 

understanding of a maturing scientific field like synthetic biology than 

approaches solely focused on developing specific applications to address contemporary needs. This understanding of basic principles may be a particularly 

valuable way to prepare for the emergence of unanticipated risks that would 

require rapid identification and creative responses.

At the same time, synthetic biology research is in competition for scarce 

resources with other areas of science and other societal needs. Decisions will 

be required regarding which research directions deserve funding over others. 

These decisions should be driven in part by which strategies offer the most 

promise based on scientific, technical, and social considerations. 

Potential profitability is also a significant motivator of research and development investments. When research is fairly new, as in the emerging field of 

synthetic biology, the promise is often high but the incentives for investment 

can be low because of uncertain success or marketability. Some drugs that 

address asymptomatic risk factors or “lifestyle” issues (e.g., drugs that do not 

treat life threatening conditions or pain), rather than specific disease processes, 

have received significant attention from the pharmaceutical industry because 
Analysis and Recommendations V

117

there is a large market and potential for profit in the United States and other 

developed nations. Some of these drugs can be quite beneficial to patients, 

such as statins to reduce elevated cholesterol levels. Drug manufacturers frequently devote research resources to the development of very similar versions of 

competitors’ already successful, profitable products instead of pursuing novel 

research directions with a less certain path to success or profits.

Other more prevalent and deadly diseases lacking therapeutic or preventive options today receive lower investment priority, especially diseases more 

common in developing nations. Absent a reliable market in the United States 

or other wealthy countries, manufacturers often choose not to devote significant investment dollars to these diseases, choices reflecting rational responses 

to the market. Government and others interested in promoting public wellbeing, such as private foundations, can effect change by re-drawing the 

financial landscape for research and development in these areas.

Recent congressional and Administration emphasis on “high risk/high 

reward” research offers one example of how the public good can be promoted 

when market forces alone may not succeed. The National Institutes of Health 

(NIH) has created several programs that specifically support creative, highly 

innovative research approaches that might otherwise be too novel or too 

risky to receive funding through traditional channels.5

 In 2007, Congress 

also expressly directed the agency to award research grants for these types of 

potentially high-impact research projects.6

 In the private sector, the Bill and 

Melinda Gates Foundation, through its “Grand Challenges in Global Health” 

program, is changing the financial picture by awarding substantial grants—

nearly $500 million dollars in recent years—to stimulate scientific innovation 

among traditional and nontraditional researchers to treat and prevent diseases 

most prevalent in developing nations.7

The development of novel antibiotics is one example in which incentives could 

help stimulate research interest toward an important public need that might 

otherwise not receive sufficient attention.8

 Similarly, funding or incentives 

to spur research into age-related degenerative diseases of the nervous system 

(including dementia and gait disorders) may help in the quest for cures for 

Alzheimer’s disease, Parkinson’s disease, and related disorders prevalent in 

aging populations.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

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The Commission’s deliberations focused specifically on synthetic biology, 

following its charge from President Obama, but alternative research strategies 

are also appropriately being pursued to address many of the national and 

global concerns for which synthetic biology may provide solutions. The 

Commission supports public and private investment in synthetic biologyrelated research as one important avenue of research among others. 

Recommendation 2: Support for Promising Research

Advancing the public good should be the primary determinant of relative 

public investment in synthetic biology versus other scientific activities. The 

National Institutes of Health, the Department of Energy, and other federal 

agencies should continue to evaluate research proposals through peer-review 

mechanisms and other deliberative processes created to ensure that the most 

promising scientific research is conducted on behalf of the public.

Synthetic biology is advancing rapidly. Future funding decisions should be 

made through ongoing evaluation of the state of the science and its potential applications. Policy makers, the scientific community, and the public 

should continue to assess the adequacy of existing peer review and funding 

mechanisms to address future advances in synthetic biology-related science 

and technology. Private interests, including for-profit and nonprofit entities, 

should likewise consider global public needs that can be uniquely advanced 

through their efforts.

Realizing Economic Opportunities

Most current attention to the potential benefits of synthetic biology focuses 

on applications related to health, energy, and the environment. Investment 

in synthetic biology also can bring economic benefits, both from the direct 

activities related to research and development and from the eventual commercialization of successful technologies. These benefits have the potential to 

strengthen communities through the creation of jobs and other opportunities, 

thereby enhancing citizens’ quality of life. Forecasting the potential impact 

of synthetic biology on job creation and economic growth is difficult, but the 

Commission received public comments estimating that the use of synthetic 
Analysis and Recommendations V

119

biology in the chemical industry alone could generate global revenue of $1 

trillion and create 1.2 million direct jobs.9

 Additional revenue and jobs would 

be expected from synthetic biology activities related to pharmaceutical and 

agricultural applications.

Potential economic benefits may be particularly valuable to communities in 

developing nations, where health, access to resources, and economic stability 

are closely linked to one another and to disparities in health and welfare. This 

underscores the importance of adopting a global perspective when considering 

the potential benefits of synthetic biology. 

Although the potential economic benefits cannot be known with precision, 

this potential should nonetheless be continually assessed as part of activities to 

promote synthetic biology. Technological solutions alone cannot eliminate the 

fundamental causes of global inequality, but they can contribute to comprehensive programs to address them. This theme is addressed when considering 

the principle of justice and fairness.

Intellectual Property and the Sharing of Scientific Knowledge

Information sharing and reasonable access to discoveries and inventions 

have long fueled the scientific enterprise. These activities enable scientists to 

leverage each other’s work in order to more quickly advance new projects 

and translate basic research into products. Impediments to innovation and 

information sharing, some say, arise from the patent and copyright system. 

These mechanisms afford inventors and authors a time-limited right to prohibit others from using their work or similar work of the same design. One 

concern consistently raised with regard to biotechnology is the potential limiting effects of intellectual property claims over research results, particularly 

in basic research.10 Patents on discoveries and restrictive or exclusive licensing 

agreements may encourage, but also may deter or increase the development 

costs of subsequent inventions that build on the basic discovery. Some who 

provided testimony to the Commission argued that the current system unduly 

limits scientific advances; others took the opposite view and asserted that the 

current system works well. 
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The patent system is designed to encourage innovation and investment by 

providing incentives to inventors to disclose their discoveries to the public 

so that others can build on them. In return, the inventor is granted exclusive 

rights to the invention and control of its development for a limited period 

of time. Balancing the interests of the inventor and those who wish to use 

the invention is a challenging task in science generally, and in biotechnology particularly. These concerns have been the focus of numerous studies, 

for example, in genomics.11 Ongoing discussions have focused on the roles 

and responsibilities of government, the academic community, and the private 

sector in adopting intellectual property practices that foster an environment 

in which invention and innovation can thrive. Such discussions are likely to 

continue as patent law and court decisions in this area evolve.12

Synthetic biology raises challenging issues in this area as a result of research 

interest in creating standard biological “parts” that can be combined to build 

new biological systems or organisms for potential use in health care, agriculture, and energy (see Chapter 3). The field also is particularly dependent on 

information technology and the need for common standards.13

Concerns about the effects of patenting on synthetic biology mirror those 

expressed about patents involving DNA and genetic tests—that is, whether 

patents will be granted that are either too narrow or too broad.14 Overly broad 

patents could “restrict collaboration and stifle development in the field, and 

narrow patents may overcomplicate the process, meaning that hundreds of 

patents have to be negotiated to produce a system from standardized parts.”15

For example, the Venter Institute is seeking a patent on the synthetic cell 

it described in May 2010 and on processes for making synthetic genomes. 

For some, these efforts raise questions about the extent to which a patent on 

synthetic organisms should be issued and whether doing so is in the public 

interest.16 Others in the synthetic biology community have taken steps to keep 

some portion of the “parts” developed with synthetic biology available in an 

open-source system (e.g., BioBricks and the Registry of Standard Biological 

Parts) without traditional patent restraints.17

In the last 20 years, we have seen increased emphasis on transparency, 

data sharing, and creative licensing practices for patentable subject matter. 
Analysis and Recommendations V

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This trend applies especially, though not exclusively, to publicly funded 

research. Examples of current data sharing requirements include several NIH

policies introduced since the late 1990s, most recently the 2007 NIH Public 

Access Policy, a congressionally mandated provision for public distribution of 

research results.18 Similar policies apply to awardees of the Howard Hughes 

Medical Institute and the Wellcome Trust, private research funding sources in 

the United States and the United Kingdom, respectively.19 Public clinical trial 

disclosure requirements have arisen from the private sector, through research 

journal publishers, and the public sector, through congressional actions in 1998 

and 2007.20 Demands for licensing inventions to meet social needs, including 

providing access to medications or enabling more research and technology 

development, have fueled innovative licensing practices and creative solutions 

to so-called “patent thickets” and other limitations on scientific exploration.21

The principle of public beneficence requires researchers, inventors, patent 

holders, and others to work together to develop creative strategies to maximize 

opportunities for innovation. Licensing alternatives could include methods of 

compulsory or bundled licensing, patent pooling, and broad, non-exclusive 

licenses for foundational technology. Because synthetic biology is in large 

part based on the application of engineering principles through the use of 

standardized, modular parts, access to those standard components could be 

especially critical to the development of the field. 

Intellectual property issues in synthetic biology are evolving. The Commission 

offers no specific opinion on the effectiveness of current intellectual property practices and policies in synthetic biology. It recognizes that there are 

important concerns that deserve ongoing attention, especially as this rapidly 

developing field evolves. Current litigation, such as Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., is likely to 

influence practices and policies in the future. This case presents the question 

of whether isolated human genes—those with mutations associated with an 

increased risk of breast cancer—and the comparison of their sequences is patentable.22 Thus, the government should keep careful watch on this field and 

consider best practices and other policy guidance, if needed, to ensure that 

access to basic research results and tasks is not unduly limited.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

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Recommendation 3: Innovation Through Sharing

Synthetic biology is at a very early stage of development, and innovation 

should be encouraged. The Executive Office of the President, as part of the 

coordinated approach urged in Recommendation 4, should lead an effort to 

determine whether current research licensing and sharing practices are sufficient to ensure that basic research results involving synthetic biology are 

available to promote innovation, and, if not, whether additional policies or 

best practices are needed. This review should be undertaken with input from 

the National Institutes of Health, other agencies funding synthetic biology 

research, such as the Department of Energy and the National Aeronautics 

and Space Administration, the U.S. Patent and Trademark Office, industry, 

academia, and public civil society groups. The review should be completed 

within 18 months and the results made public.

The Commission urges the government to consider subsequent reviews and 

coordinated assessment if needed. Information sharing is a critical mechanism 

for promoting scientific progress and innovation.
Analysis and Recommendations V

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Responsible Stewardship

The principle of responsible stewardship calls for prudent vigilance, establishing 

processes for assessing likely benefits along with assessing safety and security risks 

both before and after projects are undertaken. A responsible process will continue to 

assess safety and security as technologies develop and diffuse into public and private 

sectors. Prudent vigilance does not demand extreme aversion to all risks. Not all 

safety and security questions can be definitively answered before research begins, 

but prudent vigilance does call for ongoing evaluation of risks of harm along with 

benefits. The duty to be responsible stewards of nature, the earth’s bounty, and the 

world’s safety rests on concern not only for human health and well-being today but 

also and importantly for future generations and the environment looking forward. 

The principle of responsible stewardship can be interpreted in an operational way to pose the question, “What can and should we, as a society, do in 

response to the emerging field of synthetic biology to be responsible stewards 

of nature, the earth’s bounty, human health and well-being, and the world’s 

safety, now and into the future?” 

Options for action in this area range from doing nothing—that is, allowing 

the field of synthetic biology to proceed without limits or regard for public or 

environmental safety—to halting or substantially slowing its progress until 

risks can be identified and mitigated. One common interpretation of the “precautionary principle” would prescribe the latter approach. There are several 

definitions of the precautionary principle, but it generally states that if an 

action or policy has the potential to cause harm but uncertainty exists regarding the likelihood or severity of harm, the responsibility for demonstrating the 

safety of the approach belongs to those advocating for the policy or action. 

The precautionary principle evolved primarily in the context of European 

debates and resolutions concerning the environment and genetically modified 

foods, and it is often raised in discussions involving risk and uncertainty in 

public policy in the United States and internationally.23 One premise behind 

the precautionary principle may be that because there is a social responsibility 

to protect the public or the environment from plausible and avoidable harms, 
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protections should be relaxed only when science produces evidence that harm 

is unlikely to result. In some legal systems, such as that of the European Union, 

the application of the precautionary principle is a statutory requirement.24

A contrasting perspective is the “proactionary” principle, which assumes that 

an emerging biotechnology should be considered “safe, economically desirable 

and intrinsically good unless and until shown to be otherwise, which means 

that the burden of proof is on those who want to slow down a given line of 

research.”25 Advocates of the proactionary principle appeal to a commitment 

to intellectual freedom, the autonomy of individual decision making, economic growth, national competitiveness, and improved health and well-being. 

At its most extreme, this principle might allow science and technology to go 

forward unfettered, but, in general, proponents of this principle have supported some measure of oversight and monitoring.26

In order to provide benefits to human conditions and the environment, the 

Commission thinks it imprudent either to declare a moratorium on synthetic 

biology until all risks can be determined and mitigated, or to simply “let 

science rip,” regardless of the likely risks. The field of synthetic biology can 

proceed responsibly by embracing neither the precautionary principle nor the 

proactionary principle. The Commission instead proposes a middle ground—

an ongoing system of prudent vigilance that carefully monitors, identifies, and 

mitigates potential and realized harms over time. It came to this position for 

several reasons.

First, synthetic biology does not necessarily raise radically new concerns or 

risks compared to those that have been expressed about other emerging technologies, for example, molecular biology and nanotechnology. In many ways, 

synthetic biology is an extension of genetic engineering and part of an increasingly interconnected network of scientific disciplines including, among others, 

nanotechnology and information technology.27

Second, many existing oversight mechanisms and bodies (statutory, regulatory, and voluntary) are well situated and in the process of reviewing and 

monitoring the field of synthetic biology as it develops. The Commission 

endorses activities aimed at ensuring that those mechanisms and bodies are 
Analysis and Recommendations V

125

sufficiently well coordinated and supported to effectively monitor risks in an 

ongoing and proactive fashion.

However, synthetic biology does introduce some possible risks that warrant 

special attention. According to the National Science Advisory Board for Biosecurity (NSABB), synthetic biology poses “varying degrees of uncertainty 

regarding the predictability of biological properties of partially or completely 

synthetic agents or materials.”28 It also poses some unusual potential risks, as 

“amateur” or “do-it-yourself” (DIY) scientists and others outside of traditional 

research environments explore the field. These risks must be identified and 

anticipated—as they are for other emerging technologies—with systems and 

policies to assess and respond to them while supporting work toward potential 

benefits. In this section, the Commission considers several approaches to promoting responsible stewardship, including oversight mechanisms, establishing 

safeguards, supporting relevant research, and encouraging and developing a 

culture of responsibility. 

Stewardship through Oversight

Scientists have been conducting biological research that poses risks throughout the history of modern science. Consider Edward Jenner’s experiments 

200 years ago to develop a smallpox vaccine using cowpox virus, or more 

recently, gene therapy for rare diseases and studies of pathogens that could 

kill or sicken thousands through a natural or malevolent environmental 

release. History tells us that such research has resulted in enormous benefits 

for society, but it sometimes has had terrible consequences. Over time, safety 

and security practices and procedures have expanded and evolved to increase 

the likelihood that risks will be anticipated, mitigated, and monitored and 

that responses can be activated quickly should harms arise. 

In the United States, oversight frameworks already exist for many activities 

of modern biological science including research involving humans, animals, 

microorganisms and toxins, and recombinant DNA. Oversight also occurs 

with regard to laboratory worker safety, use of federal funds in research, and 

transport and containment of dangerous agents. Oversight is frequently, but 

not exclusively, tied to public funding or the need to gain regulatory approval 

in order to market or distribute a product (see Chapter 4).
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Long-standing regulatory systems, for example for food, drugs, and chemicals, undergird such approaches, while others developed specifically around 

the fields of genetic engineering and biotechnology. Some grew out of what 

were initially, and in some cases remain, voluntary self-policing efforts. These 

policies tend to be predicated on a risk-benefit assessment that is scaled 

according to identified risk and that evolves through an ongoing process of 

open public dialogue.29 Over time, reflecting principled flexibility, many have 

been modified as risks, or the lack thereof, became clearer.

Demonstrating the government’s increasing attention to this new field, the 

evolving federal oversight framework for synthetic biology, in the past year 

alone, includes:

•	 a proposed revision of the NIH Guidelines for Research Involving Recombinant DNA Molecules to address synthetic biology,30

•	 development of a U.S. government Screening Framework Guidance for 

Providers of Synthetic Double-Stranded DNA,

31

•	 development of an Animal and Plant Health Inspection Service (APHIS)/

Centers for Disease Control and Prevention (CDC) guidance on how current 

Select Agent regulations apply to those who create and use synthetic genomic 

products,32 and 

•	 consideration by the NSABB of strategies for conducting outreach to all 

practitioners of synthetic biology, enhancing the culture of responsibility, 

and promoting international engagement.33

These efforts build on the existing oversight responsibilities exercised by 

various federal agencies, including the Environmental Protection Agency 

(EPA) (chemical safety), the Food and Drug Administration (FDA) (food, 

drugs, and medical devices), the Department of Agriculture (crops and animal 

feed), and the Department of Homeland Security (biosecurity). 

Internationally, the community of scientists working in synthetic biology, as well 

as policymakers and ethicists, are also focusing on ways to assure responsible 

stewardship. For example, the European Commission supports SYNBIOSAFE, 

a collaborative project among public and private parties that is researching the 

safety and ethics of synthetic biology. Governance and oversight strategies for 
Analysis and Recommendations V

127

synthetic biology research and products are similarly being addressed through 

multiple efforts at the international level.34

To assure responsible stewardship in the field of synthetic biology, clarity, 

coordination, and accountability must exist across the government. The Commission does not believe that new agencies, offices, or authorities must be 

developed at this time, if ever. Instead, the Executive Office of the President 

(EOP) should lead an interagency process to identify and clarify, if needed, 

existing oversight authorities and to ensure that the government is fully 

informed on an ongoing basis of developments, risks, and opportunities as 

this field grows.

Recommendation 4: Coordinated Approach to Synthetic Biology

The Commission sees no need at this time to create additional agencies 

or oversight bodies focused specifically on synthetic biology. Rather, the 

Commission urges the Executive Office of the President, in consultation 

with relevant federal agencies, to develop a clear, defined, and coordinated 

approach to synthetic biology research and development across the government. A mechanism or body should be identified to: (1) leverage existing 

resources by providing ongoing and coordinated review of developments 

in synthetic biology, (2) ensure that regulatory requirements are consistent 

and non-contradictory, and (3) periodically and on a timely basis inform 

the public of its findings. Additional activities for this coordinating body or 

process are described in other recommendations.

These activities might be carried out, for example, under the auspices of the 

Office of Science and Technology Policy in the EOP, or the Emerging Technologies Interagency Policy Coordination Committee. It is essential that they 

be coordinated by an office with sufficient authority to bring together all parts 

of the government with a stake in synthetic biology. It is similarly important that this effort be sufficiently authoritative to effectively engage with, or 

supervise engagement with, foreign governments. A critical component of this 

coordinated strategy is to assure both the scientific community and the public 

that biosafety, biosecurity, and environmental risks of synthetic biology are 

fully addressed. 
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In any scientific inquiry, risks must be justified by anticipated benefits. Such 

balancing of risks and potential benefits is often complicated by uncertainty. 

Because much of science explores the unknown, policy makers should develop 

policies that acknowledge uncertainty about both risks and potential benefits. Information, flexibility, and judgment are critical to find the appropriate 

balance and determine the most responsible way to proceed. The rapid development of the field of synthetic biology makes the challenges of decision 

making under conditions of uncertainty particularly acute.

Recommendation 5: Risk Assessment Review and Field Release Gap Analysis 

Because of the difficulty of risk analysis in the face of uncertainty—particularly for low-probability, potentially high-impact events in an emerging 

field—ongoing assessments will be needed as the field progresses. Regulatory 

processes should be evaluated and updated, as needed, to ensure that regulators have adequate information. As part of the coordinated approach urged in 

Recommendation 4, the Executive Office of the President should convene an 

interagency process to discuss risk assessment activities, including reasons for 

differences and strategies for greater harmonization across the government. 

It should also identify any gaps in current risk assessment practices related 

to field release of synthetic organisms. These reviews should be completed 

within 18 months and the results made public.

Individual scientists were among the first to raise concerns about the possible 

risks posed by synthetic biology research. In fact, synthetic biologists have 

been discussing among themselves the appropriate safety policies for their 

field since at least 2004. Members of the synthetic biology community have 

met in a series of meetings over the past 6 years to discuss concerns about 

both biosafety and biosecurity. They also considered environmental concerns 

and appropriate tools for risk assessment.35 Like SYNBIOSAFE in Europe, 

the Synthetic Biology Engineering Research Center, a collaborative project 

funded by the National Science Foundation in the United States, is examining safety, security, and preparedness issues.36 The willingness and initiative 

of the scientific community to engage in this level of introspection is both 

reassuring and essential.37
Analysis and Recommendations V

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Similar to researchers in the early years of recombinant DNA research in the 

mid-1970s, those closest to this emerging field have exercised caution. While 

self-governance is not a sufficient means to mitigate all risks, it is likely an 

effective way to control many of the risks associated with emerging technologies, including synthetic biology, particularly at this early stage.38 Individual 

scientists and students typically are the first to notice the laboratory door ajar, 

the suspicious behavior, or the lack of safety precautions among colleagues.

The activities of nontraditional scientists involving synthetic biology are also 

noteworthy. Communities of “amateur” scientists are actively working to increase 

understanding of potential physical and environmental risks posed by synthetic 

biology activities. As these communities grow, organized efforts to engage this 

community in discussions of safety and security and to foster a commitment to 

responsible stewardship will be increasingly important (see pp. 146-148). 

Industry, too, has worked collaboratively to enact policies to promote responsible stewardship. For example, both the International Gene Synthesis 

Consortium and the International Association of Synthetic Biology—whose 

members include the vast majority of the gene synthesis providers in the United 

States and worldwide—have developed best practice guidelines for screening 

orders and customers. These groups are participating actively in public discussions of regulatory options, collaborating on implementing screening practices, 

and interacting with the Federal Bureau of Investigation (FBI) on training and 

notification efforts.39 Moreover, these organizations and their member companies have committed publicly to improve screening protocols and tools and to 

incorporate recent U.S. government guidance into practice.40

Stewardship through Use of Safety Features and Reviews

Coordination and careful risk analysis are essential steps for responsible stewardship, but they are not sufficient. There are several additional approaches, 

known today and evolving as our abilities in this field grow, to limit uncertain 

risks in synthetic biology. Technology can be harnessed to build in safeguards, 

just as cars have brakes and seatbelts, houses have smoke detectors, and computers have anti-virus software. A number of safety features can be incorporated 

into synthetic organisms to control their spread and life span.
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The intentional and unintentional consequences of novel research designs and 

new products cannot always be predicted. In the case of a newly engineered 

synthetic organism, for example, lack of history regarding the behavior of the 

entity, either environmentally or ecologically, requires that there be a means 

to track or contain it if it can survive outside of the laboratory.

Surveillance or containment of synthetic organisms is a concrete way to 

embrace responsible stewardship. These safety features may require some combination of public investment and incentives for additional private funding, 

and they should be implemented only after they undergo rigorous testing and 

validation.41 Promoting and supporting efforts to design and employ safeguards will ensure that they are widely adopted and become a standard tool 

for practitioners of synthetic biology. 

As part of the coordinated approach described in Recommendation 4, and on 

an ongoing basis as the field progresses, the government should specifically 

monitor the potential risks of organisms with novel synthetic traits or properties surviving or multiplying in the natural environment. As needed, reliable 

containment and control mechanisms should be identified and required. 

Among current options, “suicide genes” or other types of self-destruction 

triggers could be considered in order to limit the life spans of synthetic organisms.42 Organisms could also be designed to require nutritional components 

absent outside the laboratory, such as novel amino acids, thereby controlling 

them in the event of release. These are options only and should be updated as 

science progresses. The primary consideration is to ensure that concrete protections are inserted into synthetic organisms to assure safety.

Recommendation 6: Monitoring, Containment, and Control

At this early stage of development, the potential for harm through the inadvertent environmental release of organisms or other bioactive materials 

produced by synthetic biology requires safeguards and monitoring. As part of 

the coordinated approach urged in Recommendation 4, the Executive Office 

of the President should direct an ongoing review of the ability of synthetic 

organisms to multiply in the natural environment and identify, as needed, 

reliable containment and control mechanisms. For example, “suicide genes” 
Analysis and Recommendations V

131

or other types of self-destruction triggers could be considered in order to place 

a limit on their life spans. Alternatively, engineered organisms could be made 

to depend on nutritional components absent outside the laboratory, such as 

novel amino acids, and thereby controlled in the event of release.

The timing of deliberate release of synthesized organisms into the environment and the need to analyze risks prior to release raises special concern. We 

must proceed carefully, particularly when the probability or magnitude of 

risks are high or highly uncertain, because biological organisms may evolve or 

change after release.43 Generally, the paradigm for risk assessment throughout 

the scientific community and oversight agencies is to evaluate a new organism 

in terms of known relatives and to set containment rules or environmental 

risk mitigation strategies based on the applicable rules for the known relative 

(see p. 83). This approach appears to have worked effectively and enabled risk 

assessors to modify methods as science has evolved.44 Prudent vigilance is 

required to ensure that this strategy of comparison to known relatives, when 

they exist, remains effective as synthetic biology advances. 

Recommendation 7: Risk Assessment Prior to Field Release

Reasonable risk assessment should be carried out, under the National Environmental Policy Act or other applicable law, prior to field release of research 

organisms or commercial products involving synthetic biology technology. 

This assessment should include, as appropriate, plans for staging introduction or release from contained laboratory settings. Exceptions in limited cases 

could be considered, for example, in emergency circumstances or following 

a finding of substantial equivalence to approved products. The gap analysis described in Recommendation 5 should determine whether field release 

without any risk assessment is permissible and, if so, when.

This recommendation is not intended to suggest that a National Environmental Policy Act-style risks evaluation must be conducted in all cases. As noted, 

there are numerous models and strategies employed across the government 

for risk assessment, for example, through FDA’s premarket and post-market 

processes, EPA’s Toxic Substances Control Act processes, and others. The goal 

of this recommendation is to ensure that for any field release there is adequate 
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consideration of risk. Through the suggested inter-agency process, the government may find that for some products—for example, first-generation fruits or 

vegetables developed with synthetic biology instead of traditional recombinant methods—there is no material need to establish formal risk assessment 

and premarket approval if not required already under existing law. Because of 

the uncertainty surrounding this novel technology and the great potential it 

presents for confusion and public fear, Recommendations 5 directs the government to affirmatively examine current policies for field release, to ensure 

that they are adequate, and to disclose to the public the results of this review.

The Commission’s deliberations also highlighted the degree to which synthetic biology is an international enterprise. From student competitions to 

commercial gene synthesis companies, the synthetic biology community 

is an interactive global network. Oversight and regulatory mechanisms 

should adopt an analogous approach, so that the United States is involved 

in regular discussions with other national and transnational organizations, 

together seeking coordination and consistency when possible. These interactions should foster international collaboration as well as provide opportunities 

for the United States to learn from the positive and negative experiences of 

other countries similarly striving to promote the safe development of this 

field. International cooperation to create, maintain, enforce, and periodically 

update universal safety standards is essential.

Recommendation 8: International Coordination and Dialogue

Recognizing that international coordination is essential for safety and security, the government should act to ensure ongoing dialogue about emerging 

technologies such as synthetic biology. As part of the coordinated approach 

urged in Recommendation 4, the Executive Office of the President, through 

the Department of State and other relevant agencies such as the Department 

of Health and Human Services and the Department of Homeland Security, 

should continue and expand efforts to collaborate with international governments, the World Health Organization, and other appropriate parties, 

including international bioethics organizations, to promote ongoing dialogue 

about emerging technologies such as synthetic biology as the field progresses. 
Analysis and Recommendations V

133

Creating a Culture of Responsible Stewardship

Responsible conduct of synthetic biology research, like all areas of biological research, rests heavily on the behavior of individual scientists. Federal 

oversight can guide the development of a culture of responsibility and 

accountability, but it also must be fostered at the local level. Ethical as well 

as biosafety and biosecurity standards are translated into practice at the laboratory level—and by the institutions that sponsor that laboratory science.45

As an example, programs focused on homeland and transportation security 

embrace the message, “if you see something, say something.” The same is 

true for laboratory science. It is at the individual or laboratory level where 

accidents will occur, material handling and transport issues will be noted, 

physical security will be enforced, and potential dual use intentions will most 

likely be detected. 

Creating a culture of responsibility in the synthetic biology community 

could do more to promote responsible stewardship in synthetic biology than 

any other single strategy. For example, ethics education is required for most 

federally funded investigators conducting research with human subjects 

or laboratory animals.46 Similarly, researchers working with select agents 

must undergo training in biosafety and biosecurity before having access 

to select agents and pathogens.47 Researchers working with recombinant 

DNA in institutions that receive federal funds for such research know they 

must undergo review by an institutional biosafety committee (IBC) prior 

to beginning work.48 These agreements between scientists and the public 

are the terms—the social contract, one might say—for conducting “risky” 

science, and they are well understood by most of the biological and biomedical research community.

Federal funding for engineering research, in contrast to clinical research, 

generally does not include a requirement for ethics training. Recently, the 

National Science Foundation began conditioning some research awards on 

agreements that institutions mentor funded postdoctoral research fellows and 

implement plans for “appropriate training and oversight in the responsible 

and ethical conduct of research. . . .”49 Other federal research sponsors lack 

even these modest requirements. There is an urgent need more generally for 
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careful consideration of the education and training necessary to promote 

ethical conduct in engineering research and practice.

There are new actors in the world of synthetic biology, namely engineers, 

chemists, materials scientists, computer modelers, and others who practice 

outside of conventional biological research settings.50 These groups may not 

be familiar with the standards for ethics and responsible stewardship that are 

commonplace for those working in biomedical research. This poses a new 

challenge regarding the need to educate and inform synthetic biologists in 

all communities about their responsibilities and obligations, particularly with 

regard to biosafety and biosecurity.

Recommendation 9: Ethics Education

Because synthetic biology and related research cross traditional disciplinary boundaries, ethics education similar or superior to the training required 

today in the medical and clinical research communities should be developed and required for all researchers and student-investigators outside the 

medical setting, including in engineering and materials science. As part of 

the coordinated approach urged in Recommendation 4, the Executive Office 

of the President, in consultation with the National Academy of Sciences, the 

National Academy of Engineering, the scientific community, and the public, 

should convene a panel to consider appropriate and meaningful training 

requirements and models. This review should be completed within 18 months 

and the results made public.

Collectively, these recommendations are designed to balance enthusiasm 

for the potential benefits of synthetic biology with the vigilance required to 

minimize the risks associated with research in this field and its applications. 

Through technological and regulatory mechanisms, a spirit of international 

collaboration, and researcher education, the scientific and policy communities 

can work together to be responsible stewards for humankind, other species, 

and our shared environment.
Analysis and Recommendations V

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Weighing Moral Objections

The Commission’s discussion of synthetic biology thus far has focused on 

efforts to identify and assess the risks and potential benefits of research and 

development activities. Significant challenges exist for the scientific and 

regulatory communities in these areas, and these recommendations aim to 

strengthen systems to promote activity in this field while protecting against 

risks. There is a second category of concerns regarding synthetic biology, one 

that is largely independent of specific risk-benefit analyses related to proposed 

applications or research directions. These are concerns that synthetic biology 

is intrinsically objectionable from a moral perspective and should therefore 

not be allowed to proceed.51 The term “intrinsically objectionable” is used 

to express the idea that an activity or practice is “bad in itself.” The suggestion of some critics, moreover, is that no amount of vigilance, safeguards, or 

similar mechanisms could justify the transgression by synthetic biology of an 

important moral barrier.

Intrinsic objections have led to direct policy consequences in other areas of 

biomedical science and technology, most notably the restrictions on research 

related to human reproductive cloning and embryonic stem cell research. 

These types of concerns have had a long and important place in bioethical 

discussions and debates. Intrinsic objections to synthetic biology raise important issues deserving ongoing consideration as part of comprehensive efforts to 

assure that this field progresses within appropriate ethical boundaries. 

The Commission learned of several possible intrinsic objections to synthetic 

biology during its deliberations.52 In one formulation, synthetic biology is 

thought to conflict with essential concepts of human agency and life, “promoting a grandiosity about human powers or dismissiveness about the 

specialness of life.”53 The tools of synthetic biology and the technological 

capabilities they provide may, according to some critics, accentuate humankind’s temptation to hubris, suggesting an expansive, even limitless, ability 

to shape life and the future. Related to this criticism is the suggestion that 

advances in synthetic biology demonstrate that life is “nothing more than the 

sum of its parts” and that there is nothing “unique and unknowable about 
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life itself.”54 Contrasting synthetic biology with genetic engineering, medical 

ethicists Joachim Boldt and Oliver Müller write,

[S]ynthetic biology does not soften edges, but creates life forms that are 

meant not to have any edges from the start. It does not add value to an 

existing organism; it brings into existence something that counts as valuable from our point of view. Seen from the perspective of synthetic biology, 

nature is a blank space to be filled with whatever we wish.55

Boldt and Müller argue that the transition from genetic engineering to 

synthetic biology marks a profound shift from the manipulation of existing species to the creation of new forms of life, a shift having considerable 

ethical significance. They note that the metaphors commonly used in synthetic biology which describe organisms as physical artifacts—“BioBricks,” 

living machines, hardware and software—“may in the (very) long run lead 

to a weakening of society’s respect for higher forms of life that are usually 

regarded as worthy of protection.”56

Other commentators note that some of the potential products of synthetic 

biology “might fail to fit comfortably into our intuitive dichotomy between 

the living and the non-living.”57 For example, bacterial “bio-factories” are a 

potential application of synthetic biology that invokes yet another metaphor 

describing organisms in terms of physical artifacts. These bio-factories would 

possess many characteristics regularly associated with life, including a nucleic 

acid genome and the ability to reproduce. They would also possess features 

commonly associated with machines—such as modular construction and a 

rational design developed for specific applications.58 Some critics of synthetic 

biology suggest that this amalgam of characteristics, even in single-celled 

organisms, could adversely affect how we understand and treat other forms of 

life generally, not simply those produced through synthetic biology.

Another related objection to synthetic biology is that it fails to show adequate 

respect for nature and the environment.59 These critics distinguish the products of synthetic biology as unnatural in ways that other interactions between 

humans and nature are not.60 Philosopher Christopher Preston writes that 

genomes assembled through synthetic biology “depart from a core principle 
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of Darwinian natural selection—descent through modification.”61 He argues 

that synthetic biology may therefore constitute a “moral ‘line in the sand.’” 

Civil society organizations such as the ETC Group also express concern about 

the overall impact of synthetic biology on biodiversity, ecosystems, and food 

and energy supplies worldwide.62 These critiques combine intrinsic moral 

objections to the very nature of the enterprise of synthetic biology with reservations regarding its consequences and the specific harms that may result from 

continued research in the field. Biodiversity, for example, could be adversely 

affected by unpredictable outcomes of unintentional or deliberate release of synthetic organisms. Additional harms to biodiversity could result from potential 

applications of synthetic biology that aim to convert “low-value” forests and 

agricultural products into feedstocks for energy-producing processes.63

Concern for the continued flourishing of plant and animal species derives 

from the unique ability of humans to serve as responsible stewards of nature 

(see pp. 25-27). It also acknowledges the complex relationships that exist 

among species in ecosystems. Unintended consequences could result from 

potential synthetic biology applications that involve new or modified species 

in nature or novel uses for existing species.

Concerns for biodiversity are not restricted to wholesale threats to species. The 

potential of synthetic biology to enhance, add, or remove genes (and, therefore, proteins and their functions) within organisms highlights the potential 

effects of synthetic biology on genetic and genomic diversity. These impacts 

potentially extend also to genetic diversity among humans. Gene therapy 

trials using recombinant DNA in humans are already underway. However, 

genetic manipulation, as described above, is proceeding in limited and carefully controlled ways to potentially improve human health. The Commission 

is aware of no active or planned research programs involving synthetic biology 

applied to human genomes, which are vastly larger and more poorly understood than the bacterial genomes studied thus far.

Throughout its deliberations, the Commission took special efforts to learn 

the views of major faith-based communities, including those of Christianity, 

Judaism, and Islam. In other contexts, religious groups have expressed clear 
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and unqualified opposition to specific scientific activities based on intrinsic 

arguments, such as the position of the Catholic Church on human embryonic stem cell research. Similar opposition to synthetic biology has not been 

voiced thus far. Following the publication of the Venter Institute’s paper, an 

official from the Catholic Church praised the development as “a further mark 

of man’s great intelligence, which is God’s gift enabling man to better know 

the created world and therefore to better order it.”64 The statement encouraged 

continued synthetic biology research, provided that the research proceeded 

responsibly and did not undercut the sanctity of life. 

The Commission did not hear or identify any specific objections to current 

research efforts in synthetic biology based on the views of organized religions. In response to claims by some commentators that the Venter Institute’s 

research demonstrates that life is merely a manipulable series of chemical 

reactions without any unknowable mystery or value, the Commission heard 

compelling rebuttals from several faith-based thinkers and others, including 

many scientists. Among them, it heard that absolutely nothing accomplished 

in synthetic biology by way of synthesizing the genome of a self-replicating 

bacterial cell from its component parts—which is the most striking and specific technical achievement of the Venter Institute team—demonstrates that 

life is without mystery or value that goes beyond the assembly of its parts. The 

mystery of life is amply great, as both religious and secular minds can appreciate, to survive even the most masterful scientific feats.65

As a scholar from the Christian tradition commented to the Commission 

during its deliberations, 

The mystery of existence from a Christian theological standpoint is that 

anything is rather than nothing, that there is something rather than 

nothing. That life is possible. The dynamism and the energy of matter 

and being itself are taken as an expression of the very vitality of God. And 

neither wonder nor mystery it seems to me are vitiated by the fact that 

we have figured out the biomechanical and bioelectrical and biochemical 

mechanisms thereof.66
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Although contemporary synthetic biology is occasionally described as “creating life,” (see pp. 155-157) this, as a factual matter, has not happened. 

The field currently is capable of significant but quite limited technical 

achievements. Potential developments that would raise further intrinsic concerns—the synthesis of genomes for a higher order or complex species, for 

example—are not currently possible. There is widespread agreement that this 

will remain the case for the foreseeable future. Synthetic biology is currently 

capable of manipulation and duplication of genomes of single-celled organisms. The creation of novel, complex organisms de novo, the focus of some 

opposition to synthetic biology on intrinsic grounds, is a far more difficult 

technical achievement. The Commission does not find it to be an inevitable 

consequence of recent and ongoing research activities in synthetic biology. 

After careful deliberation, the Commission was not persuaded by concerns 

that synthetic biology fails to respect the proper relationship between humans 

and nature. It was reminded during its deliberations of the challenges of 

defining “nature” or “natural” in this context, particularly in light of humans’ 

long history interacting with and affecting other species, humankind, and 

the environment.67 Damaging consequences have resulted from some of this 

past activity. The Commission believes, however, that opposition to synthetic 

biology at present on such grounds alone does not adequately reflect the relationship of this technology to previous scientific activities and the current 

limited capabilities of the field. 

These varied concerns are quite valuable, however, in calling attention to 

fundamental, challenging questions regarding how to best understand interactions among humans, technology, and nature beyond the limited context 

of synthetic biology. To what extent and in what valuable ways are the many 

different kinds of life on earth more than the sum of their standardized and 

non-standardized biological parts? Such discussions and the related attention they direct toward potential objections to synthetic biology will surely 

continue as the field matures, as well they should. The question relevant to 

the Commission’s present review of synthetic biology is whether this field 

brings unique concerns that are so novel or serious that special restrictions 

are warranted at this time. Based on its deliberations, the Commission has 

concluded that special restrictions are not needed, but that prudent vigilance 
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can and should be exercised. As this field develops and our ability to engineer 

higher-order genomes using synthetic biology grows, other deliberative bodies 

ought to revisit this conclusion. In so doing, it will be critical that future 

objections are widely sought, clearly defined, and carefully considered within 

their appropriate context.

Recommendation 10: Ongoing Evaluation of Objections

Discussions of moral objections to synthetic biology should be revisited 

periodically as research in the field advances in novel directions. Reassessment 

of concerns regarding the implications of synthetic biology for humans, other 

species, nature, and the environment should track the ongoing development of 

the field. An iterative, deliberative process, as described in Recommendation 

14, allows for the careful consideration of moral objections to synthetic 

biology, particularly if fundamental changes occur in the capabilities of this 

science and its applications.
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Intellectual Freedom and Responsibility 

Democracies depend on intellectual freedom coupled with the responsibility of individuals and institutions to use their creative potential in morally responsible ways. 

Sustained and dedicated creative intellectual exploration begets much of our scientific and technological progress. A robust public policy regarding the responsible 

conduct of science must promote the creative spirit of scientists and unambiguously 

protect their intellectual freedom. At the same time, responsible science should reject 

the technological imperative: the mere fact that something new can be done does not 

mean that it ought to be done. 

Society as a whole has a stake in what scientists and engineers do. In turn, scientists and engineers should recognize the potential impact of their research on those 

who will experience both its benefits and burdens and their responsibility to those 

who provide the means, directly or indirectly, for their research. As a corollary to 

the principle of intellectual freedom and responsibility, the Commission endorses 

a principle of regulatory parsimony, recommending only as much oversight as is 

truly necessary to ensure justice, fairness, security, and safety while pursuing the 

public good.

The section on responsible stewardship stressed the importance of regulatory parsimony, recommending limiting regulation to that which is necessary 

to promote public safety and security, public beneficence, and justice and 

fairness. In its discussion of democratic deliberation (see pp. 152-155), the 

Commission recognizes the important part that all citizens can serve in 

working together for the common good. Responsible stewardship and democratic deliberation are two important components of a framework that 

promotes intellectual freedom coupled with responsibility. This section 

examines the central role of this principle in supporting the development of 

synthetic biology and other emerging technologies.

Intellectual freedom lies at the heart of America’s scientific enterprise. Such 

freedom facilitates the innovation and industry that have fueled its success. 

History is rife with examples in which ingenuity, hard work, and unfettered creativity have yielded extraordinary, sometimes unexpected, scientific 
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advances for the betterment of society as a whole. From Benjamin Franklin 

studying electricity with a kite in a raincloud, to the Wright Brothers testing 

different aerodynamic control systems and building the first successful airplane, students learn every day about the value of intellectual and scientific 

freedom and exploration.

Scottish scientist Alexander Fleming famously discovered the antibiotic penicillin by chance in 1928 after observing an area on a mold-contaminated 

Petri dish where bacteria did not grow. David Hewlett and William Packard 

started in their backyard garage an electronics revolution that continues to the 

present, working in the 1930s in what is now described as the “birthplace of 

Silicon Valley.” And the Internet, with its vast reach today, began as a simple 

idea to share data among U.S. Defense Department researchers in the 1960s. 

These examples show that the precise outcomes of open scientific exploration 

and discourse cannot always be predicted, but the value they deliver as the 

engine of progress, in science and in society overall, is unparalleled. 

Intellectual freedom and responsibility can be understood in two senses. First is 

the special institutional attribute—academic freedom and responsibility—that 

pertains to the “academy” (broadly speaking, universities and the scholars and 

researchers whose professional standing carries with it the rights and responsibilities of academic freedom). Some research involving synthetic biology today 

occurs in this setting, which includes unique institutional structures to promote 

the responsibility that accompanies intellectual freedom. Second is the right of 

all individuals to freedom of inquiry. The DIY research communities and other 

private researchers are exercising such freedom but without the institutional 

norms and procedures designed to assure responsibility, although these groups 

often develop their own mechanisms intended to do so.

In academic communities, intellectual freedom is essential. The ability to 

explore ideas openly and freely—even controversial or unpopular ideas—is 

fundamental to the mission of education and research. “The common good 

depends upon the free search for truth and its free exposition,” according to 

one widely endorsed statement on academic freedom.68 Academic freedom 

is not to be confused with license; it protects neither socially irresponsible 

behavior (the abuse of one’s academic office) nor research that poses risks to 
Analysis and Recommendations V

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individuals or institutions without adequate safeguards. Its limitations notwithstanding, the free exchange of ideas is essential to both academic inquiry 

and to the overall health of societies, and is recognized to be vital in the 

United States and other modern democracies. Protecting this core freedom—

while meeting the corresponding responsibilities—is among the foremost 

concerns of academic communities. 

Certain regulatory and norm-based constraints on academic and intellectual 

freedom in academic and other settings ensure that scientists act responsibly to protect others. In academic science, universities and other institutions 

accept the responsibility to abide by safety and security measures in laboratory research. These institutions, government, and most industry research 

programs employ extensive quality assurance and control processes that satisfy 

both external mandates and internal needs. In non-academic settings, like 

some DIY synthetic biology communities, recognition and acceptance of such 

processes are less common. In some cases, practitioners unaffiliated with an 

institution are simply unaware of applicable or reasonable restrictions governing scientific research methods intended to promote security and safety.69

Research Oversight Policies and Practices 

Citizens and their leaders should have a voice in deciding the conditions 

and direction of research efforts, especially, though not exclusively, when 

public funds are used. Likewise, scientists have a responsibility to ensure that 

they use public monies wisely and act in ways consistent with public trust. 

Recognizing this responsibility, scientists at the early stages of the genetic 

engineering revolution came together to develop what remains a substantially 

self-regulated system to protect against physical risks in genetic research. At 

the historic Asilomar Conference on Recombinant DNA in 1975, scientists 

developed a set of principles that required containment measures to be an 

essential consideration in experimental design and that “the effectiveness of 

the containment should match, as closely as possible, the estimated risk.”70

Although the scientists recognized that it might be difficult to predict the 

level of risk for any particular experiment given the novel character of the 

research, the guidelines established graded containment strategies and categorized expected areas of inquiry, setting minimum levels of containment 
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within the graded system. Like atomic scientists before them, the scientists 

who participated at Asilomar recognized that the uncertain nature of the 

risks associated with their efforts demanded that they act cautiously and with 

utmost attention to the public interest. They agreed to defer types of research 

that could not be carried out at that time with sufficient safeguards. 

Building on this framework, scientists both in and outside government developed a shared culture of responsibility to assure safe conduct of research in 

the largely uncharted world of genetic engineering. In the 35 years since Asilomar, the then-nascent field of genetic engineering research has flourished. 

Its safety continues to be governed by a dynamic process of active engagement 

among scientists in academia, government, and the private sector. 

Synthetic biology today finds itself in a position similar to the field of genetic 

engineering in 1975. Some urge extreme caution and prohibition until safety 

is proven, and others are perhaps too sanguine, dismissing all efforts that 

might limit intellectual freedom and scientific exploration. As mentioned 

in the sections on responsible stewardship and democratic deliberation, the 

Commission finds neither of these approaches appropriate. The principle 

of intellectual freedom and responsibility leads us to the conclusion that 

restrictions on research, whether by self-regulation among scientists or by 

government intervention, should limit the free pursuit of knowledge only 

when the perceived risk is too great to proceed without limit. Restrictions can 

prevent research harms but also can impede innovation and progress that may 

itself reduce harms. 

In 2009, NIH recommended that synthetic biology research should be overseen at this time in the same manner as more traditional genetic engineering 

research. The Commission agrees. The NIH Guidelines for Recombinant DNA 

Research (the NIH Guidelines), discussed in Chapter 4, establish safety conditions based on the risk profile of the end product, for example, a genetically 

modified virus strain, rather than the techniques used to make it. Risks are 

assessed and safety precautions imposed based on risks, but research is not 

limited or restricted in the absence of realistic and identified concerns. This 

framework is time-tested, familiar to most researchers, and consistent with 

the principle of intellectual freedom and responsibility. 
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A moratorium at this time on synthetic biology research generally or in particular areas would inappropriately limit intellectual freedom. Instead, the 

scientific community—in academia, government and the private sector—

should continue to work together to evaluate and respond to known and 

potential risks of synthetic biology as this science evolves. 

Recommendation 11: Fostering Responsibility and Accountability

The government should support a continued culture of individual and corporate responsibility and self-regulation by the research community, including 

institutional monitoring, enhanced watchfulness, and application of the 

NIH Guidelines for Recombinant DNA Research. As part of the coordinated 

approach urged in Recommendation 4, the Executive Office of the President 

should evaluate, and re-evaluate periodically, the effectiveness of current 

research oversight mechanisms and determine what, if any, additional steps 

should be taken to foster accountability at the institutional level without 

unduly limiting intellectual freedom. Academic and private institutions, 

the public, the National Institutes of Health, and other federal funders of 

synthetic biology research should be engaged in this process. An initial assessment should be completed within 18 months and the results made public.

This activity may best be undertaken through the coordinated approach 

chosen to implement Recommendation 4. The Office of Science and Technology Policy or another Executive Branch office could also direct this review. 

The responsible office must be empowered to bring together all relevant agencies and departments and assure effective engagement with outside groups. 

The notion of “enhanced watchfulness” requires the scientific community 

to recognize the varied risks associated with synthetic biology and develop 

internal processes to identify and respond to potential threats rapidly and 

effectively. Enhanced watchfulness reflects a relationship among scientists, 

citizens, and policy makers built on trust and mutual respect. To earn and 

preserve public trust, the research community should actively engage in continuing efforts to promote the safe development of synthetic biology and to 

recognize potential threats before they cause harm. 
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A culture of responsibility is particularly effective in university settings where 

academic freedom is an institutionalized right but not an unrestricted license. 

The responsibilities attendant to this freedom are implemented through 

practical mechanisms that nurture and support the culture of responsibility. Compliance with the NIH Guidelines, for example, is assured through 

a series of internal checks and balances from the investigator through to 

local oversight committees (e.g., IBCs) and the institutional signing official 

responsible for assuring that the institution meets all terms and conditions 

of research funding. 

Researchers in institutions outside the university setting also have an incentive to limit risks and frequently have systems in place to support and sustain 

the culture of responsibility. Biotechnology companies staffed with scientists 

trained in academia and accustomed to working with oversight committees 

like IBCs often volunteer to comply with the NIH Guidelines and other standards developed through consensus of the scientific community.71 Researchers 

in government agencies are also familiar with IBC review and the NIH Guidelines, and often are required to comply with them (see pp. 89-90).

Nurturing this same culture among DIY investigators or others outside of 

institutional settings is more challenging. The global expansion of DIY synthetic biology raises fears about biosafety and biosecurity. The open access 

environment underpinning many DIY efforts, as well as the increasing 

affordability and availability of synthetic biology tools through private gene 

synthesis companies and others, generates understandable concern about the 

ongoing effectiveness of self-regulation and the culture of responsibility standard. In partial response, the FBI expanded efforts in the last few years to 

partner with industry and actively engage the DIY community on safety concerns and risk mitigation strategies.72

The principle of intellectual freedom and responsibility, when responsibility 

is exercised largely by individual rather than institutional actors, requires the 

government to be particularly vigilant, although perhaps no more limiting of 

research efforts. To exercise the appropriate level of oversight, the government 

will need to monitor the growth and capacity of researchers outside of institutional settings. This effort may require the government to expand current 
Analysis and Recommendations V

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oversight or engagement activities with these non-institutional researchers. 

NIH or the Department of Energy, for example, could be charged to sponsor 

education programs and workshops that bring together these groups. They 

could fund training grants or related programs to promote responsibility 

among this community.

Recommendation 12: Periodic Assessment of Security and Safety Risks

Risks to security and safety can vary depending on the setting in which 

research occurs. Activities in institutional settings, may, though certainly do 

not always, pose lower risks than those in non-institutional settings. At this 

time, the risks posed by synthetic biology activities in both settings appear 

to be appropriately managed. As the field progresses, however, the government should continue to assess specific security and safety risks of synthetic 

biology research activities in both institutional and non-institutional settings 

including, but not limited to, the “do-it-yourself” community. As part of 

the coordinated approach urged in Recommendation 4, the Executive Office 

of the President, working with the Department of Homeland Security, the 

Federal Bureau of Investigation and others, should undertake and periodically update this assessment. An initial review should be completed within 18 

months and the results made public to the extent permitted by law.

As above, this activity could be undertaken by a central office implementing 

Recommendation 4, but it need not be, provided that the implementing office 

has sufficient authority to accomplish this charge. The analysis recommended 

here should identify efforts to bring the non-institutional communities into 

the ongoing culture of responsibility and local accountability that currently 

exists in many institutional settings. 

This recommendation acknowledges that the norms of safe and responsible 

conduct that have evolved over time for many researchers in institutional settings may not be understood or followed by those new to the field or outside 

of these settings, but it is not a call for specific restraints upon the DIY community at this time. Synthetic biology is occasionally critiqued as scientists 

“playing God,” (see pp. 155-157), but a more general concern is ensuring that 

all scientists, particularly DIY scientists, reject a culture of play and adopt a 
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culture of responsibility as it relates how they view their own research in a field 

fraught with risks to themselves, the public, and the environment.

It is important to note that there is presently no serious risk of completely 

novel organisms being constructed in non-institutional settings such as the 

DIY community. The research result announced by the Venter Institute in 

May 2010 was a significant technical achievement, but the synthesis of a selfreplicating bacterial cell with a synthetic genome required nearly 15 years of 

work by a large team of highly experienced scientists and an estimated $40 

million in research expenditures. The Commission’s deliberations revealed 

that this combination of technical and financial resources and scientific expertise is not currently available in the DIY community. The potential synthesis 

of completely novel organisms presents additional, still unresolved technical 

challenges even for research groups working in institutional settings. While 

there are known risks related to near-term activities by the DIY community, 

such as the growth of potentially pathogenic organisms using conventional 

methods or inadequate waste disposal practices, the risks associated with this 

group using synthetic biology techniques to create novel organisms are presently quite low.

This recommendation echoes recent conclusions of the NSABB, which also 

considered issues of education and outreach to all practitioners of synthetic 

biology and ways to effectively promote a culture of responsibility.73 Scrutiny 

is required to assure that DIY scientists have an adequate understanding of 

necessary constraints to protect public safety and security, but at present the 

Commission sees no need to impose unique limits on this group.

Assessing Oversight and Export Controls

The culture of responsibility depends, at least in part, on voluntary compliance with the NIH Guidelines in institutions without federal research funding, 

such as private companies. Accordingly, the Commission recommends that 

the government undertake an ongoing process of review to monitor risks and 

effectiveness of current oversight systems in these settings and in contexts 

such as the DIY community. 
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However, certain risks—generally involving national security—often warrant 

additional protections. One of the primary concerns about the risks posed 

by synthetic biology is its dual use potential, defined as the possibility that 

it will yield information or technologies capable of being misused, thereby 

endangering public health or national security. The threat of malevolent use 

of scientific knowledge is not new; however, the global, collaborative, and 

electronically linked nature of modern biological sciences, such as synthetic 

biology, complicates efforts to control scientific information and material 

exchanges across borders.

Where uncertainty exists regarding the danger of specific genetic sequences 

that potentially code for harmful substances, sequence providers should strive 

to ensure that customers and end-users have legitimate purposes for their use. 

Adherence to the government’s voluntary Screening Framework Guidance for 

Providers of Synthetic Double-Stranded DNA will aid these efforts.74 Scientists 

and laboratory technicians should ensure that containment and other safety 

precautions are in place. The scientific community should take steps to carefully manage both scientific and social risks associated with synthetic biology 

as this field grows.

Chapter 4 briefly describes the current system of export controls and other 

measures designed to reduce concerns about malevolent use arising from 

information exchange. Policy makers in this area face complex challenges. 

Completely free exchange of data and materials might endanger public safety, 

but unilateral action to limit exchange could damage American research 

efforts in synthetic biology if U.S. scientists and students are excluded from 

full collaboration in the international community. An additional complication 

for export control efforts in synthetic biology is that much of the “currency” 

of the field are the sequences of genetic data that are often available in public 

databases or could be distributed easily and without detection.

Several recent advisory groups have recommended ongoing discussions among 

research universities, industry, and government on this topic. The National 

Research Council’s 2007 report, Science and Security in a Post 9/11 World, 

expressly calls for more dialogue on export controls. The NSABB in 2010 

also recommended expanded outreach and education strategies “that address 
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dual use research and engage the research communities that are most likely to 

undertake work under the umbrella of synthetic biology.”75 The Commission 

agrees that scientists should be actively engaged in these debates. 

Recommendation 13: Oversight Controls

If the reviews called for in Recommendation 12 identify significant unmanaged security or safety concerns, the government should consider making 

compliance with certain oversight or reporting measures mandatory for 

all researchers, including those in both institutional and non-institutional 

settings, regardless of funding sources. It may also consider revising the 

Department of Commerce’s export controls. Any such change should 

be undertaken only after consultation with the scientific, academic, and 

research communities and relevant science and regulatory agencies such as 

the National Institutes of Health, the Department of Homeland Security, 

and the Environmental Protection Agency. Export controls should not unduly 

restrain the free exchange of information and materials among members of 

the international scientific community.
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Democratic Deliberation

The principle of democratic deliberation reflects an approach to collaborative 

decision making that embraces respectful debate of opposing views and active participation by citizens. At the core of democratic deliberation is an ongoing, public 

exchange of ideas, particularly regarding the many topics—in science and elsewhere—in which competing views are advocated, often passionately. A process of 

active deliberation and justification promotes an atmosphere for debate and decision making that looks for common ground wherever possible, and seeks to cultivate 

mutual respect where irreconcilable differences remain. It encourages participants 

to adopt a societal perspective over individual interests. With careful attention to 

the processes through which decisions are reached and justified, democratic deliberation promotes outcomes that are inclusive, thoughtfully considered, and respectful 

of competing views.

Biotechnology has the potential to affect everyone, and opportunities for 

the public to participate in discussion and deliberation about emerging technologies such as synthetic biology are critical. The principle of democratic 

deliberation highlights the importance of robust public participation in 

both the development and implementation of specific policies as well as in 

a broader, ongoing national conversation about science, technology, society, 

and values. 

In its examination of synthetic biology, the Commission saw encouraging 

examples of ways in which the public has been invited to learn about this 

emerging field and to share its perspectives. It learned of groups of citizens 

coming together, sharing their mutual interest and expertise in synthetic 

biology—biologists and engineers, teachers and students, professionals and 

amateurs, from nations around the world. These activities provide an important foundation for expanded efforts regarding public engagement and public 

education that are not only valuable but essential. This section highlights 

examples of how citizens are already shaping the present and future of synthetic biology and notes several opportunities for how these efforts can be 

enhanced and strengthened.
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Promoting an Ongoing Public Dialogue

Many groups in addition to this Commission have studied and reported on 

issues related to synthetic biology in the past several years, including U.S. 

and international government agencies, professional societies, commercial and 

industry groups, and private organizations. As the Commission did throughout its deliberations, virtually all of these groups consulted broadly among 

those with interest and expertise regarding the potential impact of synthetic 

biology on science and society. The Commission commends these efforts, as 

they embody a belief that policy regarding synthetic biology is best developed 

when informed by open and ongoing discussions among a diverse group of 

stakeholders. Policymaking bodies involved in regulation and oversight of 

synthetic biology are encouraged to continue to actively solicit input from 

the public regarding their work, ensure that those views receive thoughtful 

consideration, and make available and accessible to the public the eventual 

decisions that are reached and the reasoning for them. Public deliberation is 

particularly valuable while the field is still young, as there is a unique opportunity to shape its development in ways most likely to promote the public 

good while assuring safety and security.

The Commission understands that not all policymaking activities in this area 

can be fully transparent to the public, such as those related to some aspects 

of biosecurity or involving trade secrets in certain commercial applications of 

synthetic biology. Concerns about biosecurity and proprietary interests ought 

not, however, justify excessive secrecy such that the development of science 

and the participation of the public are unduly compromised. Nor should 

these necessary limitations preclude those with advisory or decision-making 

responsibilities from viewing the public as active partners in their work. In 

addition to being a valuable source of good ideas, public participation frequently fosters the perceived political legitimacy of the policies and practices 

that are ultimately chosen.

A recent survey of public attitudes regarding synthetic biology found that 

nearly two-thirds of respondents supported continued development of the field, 

including additional research on its possible effects on humans and the environment.76 There was a strong correlation between self-reported awareness of 
Analysis and Recommendations V

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synthetic biology and support for ongoing research, as 80 percent of those who 

had heard a lot about the field believed it should move forward, compared to 

only 52 percent of those who had heard nothing about it. Overall, 73 percent 

of those surveyed reported having heard “just a little” or “nothing at all” about 

synthetic biology. These data indicate both the need for broader public engagement regarding synthetic biology and the positive impact of such efforts on 

public support for novel and otherwise unfamiliar technologies. 

In many areas of biomedical research, public engagement is an important 

component of study design and a means to ensure public support. A notable 

example of this practice is the Framingham Heart Study and its Ethics Advisory Board. The study, which began in 1948, is a federally funded project 

based in Framingham, Massachusetts that aims to identify and understand 

the risk factors for heart disease by observing entire families and populations 

over time. The Framingham Ethics Advisory Board is comprised largely of 

past and present study participants as well as local clergy and physicians. It 

serves as a forum for community deliberations and a vehicle to advise the 

researchers on design and oversight issues.77

The development of the NIH policy on Genome-Wide Association Studies 

demonstrates another type of proactive public engagement to build public 

understanding and support. In connection with building a large-scale, central 

database of individual genotype and phenotype information for secondary 

research studies, NIH published requests for public comment during the policy 

development process and held meetings with members of the public prior to 

finalizing its policy.78 In another example, community engagement is required 

by law for certain research projects in which individual informed consent is 

not feasible, such as research conducted in emergency settings.79 Increasingly, 

community engagement or consultation is a prerequisite for research with particular populations, such as Native Americans, or research requiring the use of 

high-containment facilities to control dangerous pathogens. 

Other groups have noted the potential value of public engagement specifically 

for synthetic biology and related topics. In its April 2010 report on synthetic 

biology, NSABB recommended outreach and education directed toward 

participating scientific communities, while also stating that more active 
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engagement of the general public could lead to a better collective understanding of synthetic biology.80

An active, dynamic exchange between citizens and government need not be 

confined to regulatory and legislative processes. During its deliberations the 

Commission learned of several initiatives in which government agencies such 

as the FBI are in regular dialogue with members of the synthetic biology 

community.81 These activities provide opportunities for citizens and their government to learn from each other, exchange ideas, share concerns, and work 

collaboratively toward fostering a safe, productive environment in which synthetic biology can develop.

Government bioethics commissions such as this one can be part of national 

and international conversations regarding synthetic biology and other emerging technologies.82 While by no means a substitute for robust, ongoing 

exchanges between citizens and policy makers, the Commission’s deliberations on this matter sought to provide an inclusive forum for discussion, with 

the hope that its recommendations will be a catalyst for future deliberations.

The Commission’s interest in democratic deliberation calls for a national and 

international dialogue on synthetic biology and its implications, a conversation that bridges specific research initiatives and considers how the field as 

a whole can best move forward safely and beneficially. The Public Engagement with Research Team of the Research Councils UK is one example of an 

approach that promotes sustained interactions among researchers, students, 

and the public on major themes related to research and innovation.83

Recommendation 14: Scientific, Religious, and Civic Engagement

Scientists, policy makers, and religious, secular, and civil society groups 

are encouraged to maintain an ongoing exchange regarding their views on 

synthetic biology and related emerging technologies, sharing their perspectives with the public and with policy makers. Scientists and policy makers 

in turn should respectfully take into account all perspectives relevant to 

synthetic biology.
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Democratic deliberation encourages respect for a wide range of reasonable 

perspectives. Positions based directly on personal revelations—whether divine 

or secular in nature—are unlikely to be accessible to most citizens. However, 

by carefully attending to the concerns raised by religious traditions, a respectful dialogue can develop that can often lead to positions that are accessible, 

independent of their source.84 While the Commission did not observe significant religious concerns related to synthetic biology at this time (see pp. 

137-138), the field is young, and future developments may prompt new concerns, underscoring the importance of ongoing deliberation that is responsive 

to changing circumstances in science and society.

Striving for Accuracy and Understanding

For effective public deliberation on potentially contentious topics such as synthetic biology, participants should endeavor to express their views in ways that 

are accessible to others. In part, this means striving to convey one’s own views 

and those of others accurately and with as much mutual understanding as 

possible. Throughout its deliberations, the Commission was impressed by the 

quality of discourse on synthetic biology from those working in and around 

the field. It did observe, however, that the media sometimes described synthetic 

biology in ways more provocative than accurate. This observation may not 

be surprising to some, but it makes the development of ongoing deliberative 

forums on science all the more essential to enhancing public understanding.

In the days immediately following the May 20, 2010, announcement of 

the creation of the first self-replicating cell containing an entirely synthetic 

genome, some press accounts worldwide declared, “Scientists have created the 

world’s first synthetic life form.”85 Subsequent coverage attempted to place 

this work in context, particularly regarding whether it could properly be 

described as truly creating synthetic or artificial life. In its deliberations, the 

Commission heard that while the May 20 announcement marked a significant technical achievement in demonstrating that a relatively large genome 

could be accurately synthesized and substituted for another, it did not amount 

to the “creation of life”86 (see Chapters 2 and 3 for further discussion).
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While this interpretation of the research appears to be widely held among 

the scientific community, public perceptions of synthetic biology may have 

been influenced by initial news of “creating life.” This language may excite 

public interest in a potentially transformative field, but it can serve a useful 

purpose only if it is followed by careful and robust deliberation informed by 

an accurate understanding of the current state of synthetic biology and the 

uncertainty regarding its potential benefits and risks. This example illustrates 

the considerable opportunities and challenges facing science journalists today 

to excite public interest and convey accurate understanding of developments 

in science and technology.

Discussions about synthetic biology and related technologies often raise objections that scientists are “playing God.” The Commission’s deliberations with 

representatives of a range of religious communities found this language to 

be unhelpful at best, misleading at worst. It learned that secular critics of 

the field are more likely to use the phrase “playing God” than are religious 

groups. While religious thinkers suggested caution regarding the human tendency toward hubris, none expressed concern that synthetic biologists were 

“playing God.”87 The provocative nature of this phrase does more to obscure 

rather than to illuminate those important moral concerns regarding synthetic 

biology that deserve serious consideration (see pp. 135-140).

Recommendation 15: Information Accuracy

When discussing synthetic biology, individuals and deliberative forums 

should strive to employ clear and accurate language. The use of sensationalist buzzwords and phrases such as “creating life” or “playing God” may 

initially increase attention to the underlying science and its implications for 

society, but ultimately such words impede ongoing understanding of both 

the scientific and ethical issues at the core of public debates on these topics. 

To further promote public education and discourse, a mechanism should be 

created, ideally overseen by a private organization, to fact-check the variety of 

claims relevant to advances in synthetic biology.
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Public deliberation about synthetic biology can be hindered both by imprecise language such as “creating life” or “playing God” as well as by scientific 

claims that fail to convey accurately to the public the current state of the field, 

the implications of research results, and the limits of scientists’ present knowledge and abilities. The fact-check mechanism recommended here is intended 

to address these concerns by providing an independent venue where scientific 

claims related to synthetic biology or other emerging technologies are evaluated by impartial, qualified experts. The results of these analyses would be 

readily accessible to the public, likely through a website. The Commission 

envisions a program analogous to FactCheck.org, a project that monitors the 

accuracy of statements made about U.S. politics.88 It would be interactive, 

inviting the public to suggest claims for review by project staff, and funded by 

private sources without real or perceived conflicts of interest. 

Improving Scientific and Ethical Literacy

Meaningful citizen participation in deliberations regarding synthetic biology 

requires familiarity with general concepts in science and particular aspects of 

this developing field. Collectively, these tools are referred to as “scientific literacy.”89 The National Academy of Sciences has defined scientific literacy as “the 

knowledge and understanding of scientific concepts and processes required 

for personal decision making, participation in civic and cultural affairs, and 

economic productivity.”90

Making science accessible to the public requires creativity and innovation 

in public education. The Commission was pleased to learn that in synthetic 

biology several groups have launched commendable efforts to educate the 

public about this emerging field. These groups include the Synthetic Biology 

Project of the Woodrow Wilson International Center for Scholars and the 

Synthetic Biology Engineering Research Center, which is funded in part by 

the National Science Foundation.91 Through online resources, curricula for 

teachers and students, and events such as the International Genetically Engineered Machine (iGEM) competition (see p. 46), these and other groups 

are developing innovative programs to increase the public’s understanding of 

synthetic biology.
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Public education efforts addressing synthetic biology need to be part of our 

Nation’s expanded attention to an increasingly urgent need to enhance scientific literacy, broadly understood. Scientific literacy must go hand-in-hand 

with improved ethical literacy, meaning an understanding of moral concepts, 

traditions, and controversies concerning the responsibilities and rights of individuals and communities toward one another.

Recommendation 16: Public Education

Educational activities related to synthetic biology should be expanded and 

directed to diverse populations of students at all levels, civil society organizations, communities, and other groups. These activities are most effective 

when encouraged and supported by various sources, not only government, but 

also private foundations and grassroots scientific and civic organizations. As 

part of the coordinated approach urged in Recommendation 4, the Executive 

Office of the President, with input from the scientific community, the public, 

and relevant private organizations, should identify and widely disseminate 

strategies to promote overall scientific and ethical literacy, particularly as 

related to synthetic biology, among all age groups.

This effort could be led by EOP or the relevant science agencies such as NIH

or DOE in collaboration with the Department of Education. This group 

should consider the feasibility of including public education components or 

the development of school curriculum modules in research funding agreements. These activities could be linked to specific projects or organized at the 

institutional level among recipients of federal research support. It should also 

examine other models to promote and enhance scientific and ethical literacy, 

including activities directed by private organizations or developed by private 

groups in partnership with the government. The Synthetic Biology Project of 

the Woodrow Wilson Center may serve as one such model. 

Scientific research and public education about science are best approached as 

mutually related, even mutually dependent, endeavors. The iGEM competition, for example, combines hands-on student exposure to research tools and 

practices with education on many issues—science, safety, and policy—related 

to synthetic biology. The Commission commends programs throughout the 
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scientific community that include educational programs as components of 

ongoing research projects. One illustrative example is Project BioEYES, which 

provides classroom-based learning opportunities for students in grades K-12 

through the use of live zebrafish.92 With active participation from scientists 

committed to making science accessible to young people, over 18,000 students in Philadelphia, Baltimore, and South Bend have encountered science 

in innovative ways. In particular, this project and others similarly directed 

to under-resourced schools seek to make science available to all students, 

particularly those who might otherwise lack access to cutting-edge scientific 

resources and expertise.

In 1999, the National Bioethics Advisory Commission noted that the need for 

expanded education is “not simply...the provision of information with the aim 

of adding to the net store of knowledge by any one person or group; rather, 

education refers to the ongoing effort to inform, challenge, and engage.”93

Engaging citizens—and particularly young people—in challenging science 

curricula regarding synthetic biology and other emerging technologies as well 

as many other issues lies at the intersection of science and citizenship. In light 

of our Nation’s dependence on socially responsible scientific innovation for 

economic progress and individual well-being, the urgency of expanding effective science and ethics education cannot be exaggerated.

Fostering Grassroots Collaborations

As noted, democratic deliberation is based on ongoing interaction among 

citizens on topics of common interest. For an emerging technology such as 

synthetic biology, many of these dialogues will be among scientists or other 

interested citizens and policy makers or regulators. Such interactions are vital 

to a democracy, but they are not sufficient. Exchanges among individuals 

and groups of citizens are also important. In particular, grassroots collaborations have been established around synthetic biology. Groups such as DIYbio 

are loosely organized networks of self-described “citizen scientists” coming 

together because of a common interest in the tools, methods, and applications of synthetic biology, rather than shared professional affiliations or policy 

responsibilities. In this way, the “do-it-yourself” community embodies a “doit-together” ethos.94
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These kinds of collaborations are commendable; they strengthen notions of 

citizenship and community at the core of a democracy. They demonstrate that 

science and its oversight do not belong exclusively to experts, highly trained 

professionals, or government officials. Science is a shared resource, affecting 

and belonging to all citizens.

Through democratic deliberation, questions raised by the emerging science 

of synthetic biology can be explored and evaluated on an ongoing basis in a 

manner that welcomes the respectful exchange of opposing views. This deliberation is best positioned to succeed when it includes a diverse set of accessible 

arguments built upon a foundation of public understanding and engagement 

with science and technology. In this way, democratic deliberation advocates 

for an inclusive view of synthetic biology and its oversight. A communityoriented perspective strengthens efforts to ensure that this science develops in 

ways that will be acceptable to the majority of the population. This perspective also complements activities intended to promote justice and fairness in 

the development of synthetic biology and its applications. 
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Justice and Fairness

The principle of justice and fairness relates to the distribution of benefits and 

burdens across society. Emerging technologies like synthetic biology, for good or 

ill, affect all persons. Society as a whole has a claim toward reasonable efforts on 

the part of both individuals and institutions to avoid unjust distributions of the 

benefits, burdens, and risks that such technologies bring. This same claim extends 

internationally to all those who may be affected—positively or negatively—by synthetic biology and its applications. 

In calling attention to justice and fairness, the Commission highlights the 

importance of considering not simply what the benefits and risks of synthetic 

biology are, but to whom and to what those benefits and risks are directed. Its 

examination of synthetic biology discussed strategies intended to realize potential benefits and minimize risks by means of thorough, inclusive deliberative 

processes. These benefits and risks can be specified; they are not abstract concepts. They have the potential to directly and significantly affect individuals 

and entire populations, species, and environments. The principle of justice and 

fairness encourages a proactive sensitivity to the distribution of these outcomes. 

Justice and fairness are concepts with closely related but distinct meetings. 

Many definitions exist, but justice is generally the broader concept of the two. 

One type of justice, distributive justice, refers to concern for the equitable 

allocation of goods and evils in a society. Fairness provides one specification 

of justice, as in philosopher John Rawls’s principles of equal liberty and equal 

opportunity among members of communities as two of the primary attributes 

of “justice as fairness.”95 In its work, the Commission refers to the principles 

of justice and fairness collectively to refer broadly to concern for how benefits 

and burdens ought to be shared among communities and nations. 

Some of the most exciting potential current applications of synthetic biology 

involve products with the potential to address major challenges in global health 

and welfare. Semi-synthetic artemisinin (see p. 65), for example, could offer a 

valuable treatment for malaria around the globe. Synthetic biofuels could be 

particularly valuable in nations where energy deficits hinder development and 
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economic growth. There is great value in striving to pursue these and other 

applications and to ensure, if successful, that they reach those individuals and 

communities who would most benefit from them.

As it advances, synthetic biology may also pose a spectrum of risks to human 

health, other species, ecosystems, and national security (see Chapter 3). The 

likelihood and severity of most of these risks are difficult to predict at this 

time, but part of the work of oversight activities, broadly speaking, is to 

assess where the risks and harms of synthetic biology are most likely to be 

experienced, if at all, and act to prevent or minimize any adverse impacts. 

Research-related risks, potential environmental exposures, and social and 

economic displacement can be unavoidable hazards of science and technology, but these burdens should not fall disproportionately on any particular 

individual or group. Of great concern are those individuals and groups whose 

political, economic, or other status makes them particularly vulnerable. 

Sensitivity to the fair distribution of the risks and benefits of synthetic 

biology, like other biotechnologies, is appropriate regardless of the source of 

funding. Yet fair distribution of the benefits of synthetic biology is an especially important consideration for government-funded research. Government 

support provides both benefits and obligations. Benefits include the creation 

of a safe and secure research environment as well as direct funding for particular projects. These benefits come with a corresponding responsibility for 

beneficiaries to do their part to ensure that return on these investments is 

justly distributed across society. Concern for justice and fairness should be 

a central consideration of all aspects of the planning and implementation of 

research in synthetic biology and its applications. 

Just Distribution of Risks, Burdens, and Potential Benefits

With any technological advance come burdens and risks. These burdens can 

arise both in the research and development process and from the eventual 

introduction of new technologies and products into the marketplace. Frequently, the risks are unknown or of uncertain magnitude at the early stages 
Analysis and Recommendations V

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of development of a field. Ongoing and recurring risk assessment is often 

required to fully understand and respond appropriately. 

Chapter 3 discusses the potential benefits and risks of synthetic biology as it is 

understood today. One set of risks relates to the conduct of synthetic biology 

research. These include risks to laboratory workers and personnel, risks to 

research subjects, and risks related to the unintentional or deliberate release 

of experimental agents into the environment. In the United States, numerous 

oversight systems are in place to guard against potential harms that may result 

from these types of risks (see Chapter 4). These include provisions designed 

to prevent physical harm to workers, study subjects, and the public generally. 

For study subjects, specific mechanisms are in place to ensure that volunteers 

are fully informed about, and agree to accept, the possible risks or harms they 

may face before they begin. Oversight bodies assess research risks in light of 

potential benefits to individuals, and in some cases, communities, prior to 

approval. Many believe also that research should be responsive to the needs 

of the entire population being studied or affected by the research activities.96

Evaluation of research proposals and ongoing review should include consideration of possible environmental exposures or social disruption. These 

considerations are particularly relevant for synthetic biology. Clinical and 

observational research in this field is relatively limited at present, but harmful 

environmental effects or unintended consequences on human health loom 

as major sources of concern and public anxiety. These concerns need not be 

addressed by institutional review boards, which are commonly understood to 

be prohibited by federal regulation from considering such effects beyond their 

relevance to the protection of human subjects directly participating in the 

research.97 To address the uncertain or potentially unique risks that may arise 

from synthetic biology in light of its extraordinary potential to manipulate 

and manage living systems, special consideration and safety reviews may be 

needed. In addition to concerns about possible environmental exposures or 

social disruption, consideration must also be given to potential hazards to the 

public posed by synthetic biology consumer products, including medicines. 
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Recommendation 17: Risks in Research

Risks in research should not be unfairly or unnecessarily borne by certain 

individuals, subgroups, or populations. As part of the coordinated approach 

urged in Recommendation 4, the Executive Office of the President should 

lead an interagency evaluation of current requirements and alternative 

models to identify mechanisms that ensure that the risks of research in synthetic biology, including for human subjects and other affected parties, are 

not unfairly or unnecessarily distributed. Relevant scientific, academic, and 

research communities, including those in the private sector, should be consulted. This review should be completed within 18 months and the results 

made public.

Attention to these concerns is particularly relevant when those participating 

directly in research or likely to be affected by research activities do not share 

the nationality, culture, economic status, or political power of those conducting the research. 

The introduction of new technologies may also lead to increased risk of 

harmful environmental exposures in specific locations, and the principles of 

justice and fairness require vigilant attention to these environmental risks. 

The arrival of new products or applications of synthetic biology should not 

compel any particular population to “shoulder a disproportionate burden of 

the negative human health and environmental impacts of pollution or other 

environmental hazards.”98 All citizens ought to “enjoy the same degree of 

protection from environmental and health hazards.”99 Accordingly, the Commission makes the following recommendation as a means to expand attention 

to the relative burden that some communities or individuals may bear regarding the potentially adverse effects and risks of new technologies.

Recommendation 18: Risks and Benefits in Commercial Production and 

Distribution

Risks to communities and the environment should not be unfairly distributed. Manufacturers and others seeking to use synthetic biology for 

commercial activities should ensure that risks and potential benefits to communities and the environment are assessed and managed so that the most 
Analysis and Recommendations V

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serious risks, including long-term impacts, are not unfairly or unnecessarily 

borne by certain individuals, subgroups, or populations. These efforts should 

also aim to ensure that the important advances that may result from this 

research reach those individuals and populations who could most benefit 

from them. As part of the coordinated approach urged in Recommendation 4, 

the Executive Office of the President should evaluate current statutory mandates or regulatory requirements for distribution of risks and benefits and 

consider developing guidance materials and voluntary recommendations to 

assist manufacturers as appropriate.

There is considerable enthusiasm among advocates of synthetic biology for the 

varied benefits that this emerging field may yield for individuals and communities. Some critics have expressed concern, however, that synthetic biology 

will only exacerbate existing disparities with regard to health, welfare, and 

socioeconomic status.100 Similar concerns are often voiced in response to other 

new technologies. 

Much of the optimism surrounding synthetic biology stems directly from 

its potential to address some of the longstanding, significant problems associated with these disparities. Synthetic biology offers potential applications 

that may be particularly beneficial to less advantaged populations, including 

improved quality and access to vaccines against infectious diseases, medications, and fuel sources. A just society recognizes the value of establishing 

incentives to create new knowledge and to translate it into vibrant markets in 

ways intended to distribute benefits widely. As new tools arrive and mature, it 

will be important to identify strategies to responsibly ensure that communities and nations who may most immediately benefit are empowered to do so. 

Doing so will require ongoing review of how intellectual property and licensing arrangements can best be structured to promote both scientific innovation 

and the public good (see pp. 119-122). 

Stakeholders should work collaboratively, aiming to ensure that advances 

made possible by synthetic biology reach those who could benefit from them, 

particularly less advantaged populations. Attention to the just distribution 

of potential benefits is most effective when continually examined in concert 

with research and development activities. It encourages an awareness of the 
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full “life cycle” of a new application of synthetic biology, from initial research 

through potential global implementation. This holistic perspective recognizes 

that decisions made even in early stages of development may have consequences—technological, economic, or practical—that can affect the eventual 

implementation of potential research products positively or negatively. The 

ongoing development of semi-synthetic artemisinin is an example of a research 

program that reflects an appreciation for the challenges and importance of 

ensuring wide access to possible products.101 Research and development activities throughout synthetic biology would be well served by similar appreciation 

of the relationships among current activities, potential future implementation 

concerns, and the concepts of justice and fairness.
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1 Although current levels of public and private investment in synthetic biology are not 

available, according to the Woodrow Wilson Center, the U.S. Government has spent 

approximately $430 million on research related to synthetic biology since 2005. By 

comparison, the European Union and three individual European countries—The 

Netherlands, U.K., and Germany—spent approximately $160 million during that same 

period. See: Woodrow Wilson International Center for Scholars. (2010). Trends in Synthetic 

Biology Research Funding in the United States and Europe, June 2010, Research Brief 1.

Available at: http://www.synbioproject.org/library/publications/archive/researchfunding/. 

A few companies’ combined spending already far exceeds those public investments. (See, 

e.g., Dimond, P. (2010). Analysis & Insight: Synthetic biology—the devil is in the financial 

details. Genetic Engineering and Biotechnology News (July 13, 2010). Available at: http://

www.genengnews.com/analysis-and-insight/synthetic-biology-the-devil-is-in-the-financialdetails/77899331/.) 

2 Roll Back Malaria. (2010). Key malaria facts. Available at: http://www.rbm.who.int/keyfacts.html.

3 Rejeski, D., Director, Science and Technology Innovation Program, Woodrow Wilson 

International Center for Scholars. (2010). Synthetic Biology, the Public, and the Media. 

Presentation to the Presidential Commission for the Study of Bioethical Issues, July 9, 2010. 

http://bioethics.gov/transcripts/synthetic-biology/070910/ethics-of-synthetic-biology.html; 

Snow, A. Professor, Department of Evolution, Ecology & Organismal Biology, Ohio State 

University. (2010). Risks of Environmental Releases of Synthetic GEOs. Presentation to the 

Presidential Commission for the Study of Bioethical Issues, July 9, 2010. http://bioethics.gov/

transcripts/synthetic-biology/070810/benefits-and-risks-of-synthetic-biology.html.

4 See, e.g., Cho, M., et al. (1999). Ethical considerations in synthesizing a minimal genome. 

Science 286(5447):2087-2090; The Alfred P. Sloan Foundation. Basic Research: Synthetic 

Biology. Available at: http://www.sloan.org/program/38.

5 NIH. (2010). The NIH Common Fund—High Risk Research. Available at: http://

nihroadmap.nih.gov/highrisk/. 

6 The National Institutes of Health Reform Act of 2006. Pub. L. 109-482, 120 Stat. 3677 

(2007).

7 The Bill and Melinda Gates Foundation. Grand Challenges in Global Health. Available at: 

http://www.grandchallenges.org/explorations/Pages/introduction.aspx.

8 Kohanski, M., Dwyer, D., and J. Collins. (2010). How antibiotics kill bacteria: From targets 

to networks. Nature Reviews Microbiology 8 (June 2010):423-435; Pollack, A. (2010). 

Antibiotics Research Subsidies Weighed by U.S. New York Times. November 5, 2010.

9 Erickson, B., on behalf of the Biotechnology Industry Organization. (2010). Comments 

submitted to the Presidential Commission for the Study of Bioethical Issues, October 1, 

2010.

10 Eisenberg, R.S. (2010). Patents and data-sharing in public science. Industrial and Corporate 

Change 15(6):1013-1031. 

11 See Secretary’s Advisory Committee on Genetics, Health, and Society. (2010). Revised 

Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to 

Genetic Tests. Available at: http:// oba.od.nih.gov/oba/SACGHS/SACGHS%20Patents%20

Report%20Approved%202-5-20010.pdf; see also, National Research Council (2006). 

Reaping the Benefits of Genomic and Proteomic Research. Washington, D.C.: National 

Academies Press.
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12 Ass’n for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., 702 F. Supp. 

2d 181 (S.D.N.Y. 2010), amended by 2010 U.S. Dist. LEXIS 35418 (S.D.N.Y. 2010), appeal 

filed, No. 2010-1406 (Fed. Cir. filed June 16, 2010).

13 Henkel, J., and S.M. Maurer. (2009). Parts, property and sharing. Nature Biotechnology

27(12):1095-1098; See also, Rai, A.K., Elvin R. Latty Professor of Law, Duke University 

School of Law, Center for Public Genomics, Institute for Genome Sciences and Policy, 

Duke University. (2010). Knowledge Sharing, Innovation and Translating Research for 

the Public Good. Presentation to the President’s Commission for the Study of Bioethical 

Issues, September 13, 2010. Available at: http://www.bioethics.gov/transcripts/syntheticbiology/091310/knowledge-sharing-innovation-and-translating-research-for-the-public-good.

html.

14 SACGHS, op cit. See also Brief for the United States as Amicus Curiae in Support of Neither 

Party, Ass’n for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., 702 F. 

Supp. 2d 181 (S.D.N.Y. 2010).

15 Balmer, A., and P. Martin. (2008). Synthetic Biology: Social and Ethical Challenges (An 

independent review commissioned by the Biotechnology and Biological Sciences Research 

Council (BBSRC)). Available at: http://www.bbsrc.ac.uk/organisation/policies/reviews/

scientific-areas/0806-synthetic-biology.aspx 

16 ETC Group. (2007). Backgrounder: J. Craig Venter Institute’s patent application on world’s 

first human-made species. Available at: http://www.etcgroup.org/en/materials/publications.

html?pub_id=631.

17 The BioBricks Foundation. Available at: http://biobricks.org/.

18 Principles and Guidelines for Recipients of NIH Research Grants and Contracts on 

Obtaining and Disseminating Biomedical Research Resources: Final Notice, 64 Fed. Reg. 

72090-72096 (Dec. 23, 1999); NIH. (2003). NIH Data Sharing Policy and Implementation 

Guidance. Available at: http://grants.nih.gov/grants/policy/data_sharing/data_sharing_

guidance.htm; Consolidated Appropriations Act of 2008, Pub. L. No 110-161, §218, 121 

Stat. 1844 (2007).

19 The Howard Hughes Medical Institute. Research Policies: Confidential Disclosure Agreements

(SC-370). Available at: http://www.hhmi.org/about/research/sc370.pdf; the Wellcome Trust. 

Wellcome Trust Policy on Conflicts of Interest and Related Standards of Conduct. Available at: 

http://www.wellcome.ac.uk/stellent/groups/corporatesite/@legal/documents/web_document/

wtd002770.pdf.

20 International Committee of Medical Journal Editors (ICMJE) website. Toward More 

Uniform Conflict Disclosures: The Updated ICMJE Conflict of Interest Reporting Form 

Disclosure Policy. Available at: http://www.icmje.org/updated_coi.pdf; Food and Drug 

Administration Amendments Act of 2007, Pub. L. No 110-85,121 Stat. 823 (2007); 42 

U.S.C. § 282(i).

21 Rai, A.K., op cit.; Stevens, A.J., Special Assistant to the Vice President of Research, Boston 

University. (2010). Knowledge Sharing, Innovation and Translating Research for the Public 

Good. Presentation to the Presidential Commission for the Study of Bioethical Issues, 

September 13, 2010. Available at: http://bioethics.gov/transcripts/synthetic-biology/091310/

knowledge-sharing-innovation-and-translating-research-for-the-public-good.html.
Analysis and Recommendations V

169

22 Ass’n for Molecular Pathology, op cit.

23 For a more extensive discussion, see: Epstein, L.S. (1980). Decision-making and the temporal 

resolution of uncertainty. International Economic Review 21(2):269–283; Arrow, K.J. and 

A.C. Fisher. (1974). Environmental preservation, uncertainty and irreversibility. Quarterly 

Journal of Economics 88(2):312–319; Gollier, C., Bruno, J., and N. Treich. (2000). Scientific 

progress and irreversibility: An economic interpretation of the ‘precautionary principle.’ 

Journal of Public Economics 75(2):229–253. See also the Wingspread Consensus Statement 

at: http://www.sehn.org/wing.html.

24 Commission of the European Communities. (2000). Communication for the Commission 

on the Precautionary Principle. Brussels 02.02.2000 COM(2000) 1. Available at: http://

ec.europa.eu/dgs/health_consumer/library/pub/pub07_en.pdf.

25 Parens, E., Johnston, J., and J. Moses. (2009). Ethical Issues in Synthetic Biology: An 

Overview of the Debates. Washington, D.C.: Woodrow Wilson International Center for 

Scholars. Available at: http://www.synbioproject.org/process/assets/files/6334/synbio3.pdf.

26 Ibid.

27 Ibid.

28 NSABB. (2010). Addressing Biosecurity Concerns Related to Synthetic Biology. Available 

at: http://oba.od.nih.gov/biosecurity/pdf/NSABB%20SynBio%20DRAFT%20ReportFINAL%20(2)_6-7-10.pdf. Page 6.

29 Patterson, A., Acting Associate Director for Science Policy, National Institutes of Health. 

(2010). Federal Oversight of Synthetic Biology Research. Presentation to the President’s 

Commission for the Study of Bioethical Issues, July 9, 2010. Available at: http://www.

bioethics.gov/transcripts/synthetic-biology/070910/federal-oversight-of-synthetic-biology.

html.

30 It is noteworthy that the Recombinant DNA Advisory Committee has found that, in most 

cases, “research with synthetic nucleic acids presents biosafety risks that are comparable to 

recombinant DNA research and that certain work with synthetic nucleic acids in a nonreplicating form may not require oversight under the NIH Guidelines (although other 

biosafety standards would apply).” See NSABB, op cit., p.9.

31 DHHS, Screening Framework Guidance for Synthetic Double-Stranded DNA Providers. 

Federal Register 74(227):62319-62327. November 27, 2009.

32 APHIS/CDC. Applicability of the Select Agent Regulations to Issues of Synthetic Genomics. 

Available at: http://www.selectagents.gov/syntheticgenomics.html.

33 Patterson, A., op cit.

34 Swiss Confederation. The Swiss Federal Ethics Committee on Non-Human Biotechnology. 

(May 2010). Synthetic Biolog—Ethical Considerations. Available at: http://www.ekah.admin.

ch/fileadmin/ekah-dateien/dokumentation/publikationen/e-Synthetische_Bio_Broschuere.

pdf; International Risk Governance Council. (2009). Concept Note: Risk Governance of 

Synthetic Biology. Geneva: International Risk Governance Council. Available at: http://www.

irgc.org/IMG/pdf/IRGC_Concept_Note_Synthetic_Biology_191009_FINAL.pdf.
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

170

35 See Tucker, J.B. (2010). Double-edged DNA: Preventing the misuse of gene synthesis. Issues 

in Science and Technology (Spring 2010). 

36 Keasling, J. (2010). Testimony to Committee on Energy and Commerce, U.S. House 

of Representatives, May 27, 2010. Available at: http://energycommerce.house.gov/

documents/20100527/Keasling.Testimony.05.27.2010.pdf.

37 Synth-Ethics. Ethical and regulatory challenges raised by synthetic biology. Available at: http://

synthethics.eu/.

38 Maurer, S., and L. Zoloth. (2007). Synthesizing biosecurity. Bulletin of the Atomic Scientists

63(6):16-18; Garfinkel, M.S., et al. (2008). Synthetic Genomics: Options for Governance. 

Rockville, Maryland: The J. Craig Venter Institute. Available at: http://www.jcvi.org/cms/

fileadmin/site/research/projects/synthetic-genomics-report/synthetic-genomics-report.pdf.

39 Terrill, D., Senior Vice President and General Counsel for International and Legal Affairs, 

Integrated DNA Technologies, and Chief Operating Officer, International Consortium for 

Polynucleotide Synthesis. (2010). Biosecurity and Biosafety. Presentation to the Presidential 

Commission for the Study of Bioethical Issues, September 14, 2010; Wagner, R., Chief 

Executive Officer and Chief Scientific Officer, Geneart AG, and Professor and Chief, 

Molecular Microbiology and Gene Therapy, University of Regensburg Institute of Medical 

Microbiology and Hygiene. (2010). Biosecurity and Biosafety. Presentation to the Presidential 

Commission for the Study of Bioethical Issues, September 14, 2010. Available at: http://

www.bioethics.gov/transcripts/synthetic-biology/091410/biosecurity-and-biosafety.html.

40 Ibid. 

41 Church, G.M. (2009) Safeguarding biology. Seed (February 2009):85-86. Available at: http://

arep.med.harvard.edu/pdf/Church_Seed09.pdf .

42 Callura, J.M., et al. (2010). Tracking, tuning, and terminating microbial physiology using 

synthetic riboregulators. Proceedings of the National Academy of Sciences. Published online 

before print. Available at: http://www.pnas.org/content/early/2010/08/09/1009747107.full.

pdf+html.

43 Snow, A.A. (2003). Genetic engineering: Unnatural selection. Nature 424(7 Aug 2003):619; 

Snow, A.A., et al. (2005). ESA Report: Genetically engineered organisms and the 

environment: Current status and recommendations. Ecological Applications, 15(2):377–404. 

44 Rodemeyer, M. (2009). New Life, Old Bottles: Regulating First-Generation Products of 

Synthetic Biology. Report for the Woodrow Wilson International Center for Scholars 

Synthetic Biology Project/Syn Bio 2. Available at: www.synbioproject.org/library/

publications/archive/synbio2/; Rodemeyer, M., Lecturer, Department of Science, Technology 

and Society, School of Engineering and Applied Science, University of Virginia. (2010). 

Federal Oversight of Synthetic Biology. Presentation to the Presidential Commission for the 

Study of Bioethical Issues, July 9, 2010. Available at: http://www.bioethics.gov/transcripts/

synthetic-biology/070910/federal-oversight-of-synthetic-biology.html.

45 See, e.g., Committee on Laboratory Security and Personnel Reliability Assurance Systems 

for Laboratories Conducting Research on Biological Select Agents and Toxins; National 

Research Council. (2009). Responsible Research with Biological Select Agents and Toxins. 

Washington, D.C.: National Academies Press.
Analysis and Recommendations V

171

46 NIH. (2000). Notice OD-00-039: Required Education in the Protection of Human 

Research Participants. Available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD00-039.html

47 7 C.F.R § 331.15; 9 C.F.R § 121.15; 42 C.F.R § 73.15.

48 DHHS/NIH. (2009). NIH Guidelines for Recombinant DNA Molecules. Sec. III. Available 

at: http://oba.od.nih.gov/rdna/nih_guidelines_oba.html.

49 America COMPETES Act, Pub. L. No. 110-69, § 7009, 121 Stat. 572-718 (2007). 

50 NSABB, op cit.

51 See, e.g., Kaebnick, G. (2009). Should moral objections to synthetic biology affect public 

policy? Nature Biotechnology 27(12):1106-1108.

52 Kaebnick, G. Research Scholar, The Hastings Center. (2010). Ethics of Synthetic Biology. 

Presentation to the Presidential Commission for the Study of Bioethical Issues, July 8, 

2010. Available at: http://www.bioethics.gov/transcripts/synthetic-biology/070810/ethics-ofsynthetic-biology.html.

53 Ibid.

54 Caplan, A.L., Emmanuel and Robert Hart Director, Center for Bioethics, and Sidney D. 

Caplan Professor of Bioethics, School of Medicine, University of Pennsylvania. (2010). 

Philosophical and Theological Perspectives. Presentation to the Presidential Commission for 

the Study of Bioethical Issues, September 13, 2010. Available at: http://www.bioethics.gov/

transcripts/synthetic-biology/091310/philosophical-and-theological-perspectives.html.

55 Boldt, J., and O. Muller. (2008). Newtons of the leaves of grass. Nature Biotechnology

26(4):387-389.

56 Ibid.

57 Douglas, T., and J. Savulescu. (2010). Synthetic biology and the ethics of knowledge. Journal 

of Medical Ethics 36(11):687-693.

58 Ibid.

59 ETC Group. (2010). The New Biomassters: Synthetic Biology and the Next Assault on 

Biodiversity and Livelihoods. Available at: http://www.etcgroup.org/upload/publication/

pdf_file/biomassters.pdf.

60 Buchanan, A., James B. Duke Professor of Philosophy, Duke University; Investigator, 

Institute for Genome Sciences and Policy, Duke University; Distinguished Research 

Associate, Uehiro Centre for Practical Ethics, University of Oxford. (2010). Ethics of 

Synthetic Biology. Presentation to the Presidential Commission for the Study of Bioethical 

Issues, July 8, 2010. Available at: http://www.bioethics.gov/transcripts/syntheticbiology/070810/ethics-of-synthetic-biology.html.

61 Preston, C. (2008). Synthetic biology: Drawing a line in Darwin’s sand. Environmental 

Values 17:23-39.

62 ETC Group (2010), op cit. 

63 Ibid. 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

172

64 BBC Monitoring Europe. Vatican Dismisses Synthetic Cell’s Life-Giving Dimension, Lauds 

Science Research. May 25, 2010. Translation of Gian Guido Vecchi. Cautela in Vaticano 

‘È un ottimo motore ma non è la vita.’ Available at: http://archiviostorico.corriere.it/2010/

maggio/22/Cautela_Vaticano_ottimo_motore_non_co_9_100522032.shtml.

65 Wheeler, S.E., Martha Ashby Carr Professor of Christian Ethics, Wesley Theological 

Seminary. (2010). Contributions of Christian Thought to Assessments of Synthetic Biology. 

Presentation to the Presidential Commission for the Study of Bioethical Issues, September 

13, 2010. Available at: http://www.bioethics.gov/transcripts/synthetic-biology/091310/

philosophical-and-theological-perspectives.html.

66 Ibid.

67 Buchanan, A., op cit.; See also Lustig, B.A., Brody, B.A., and G.P. McKenny (eds.). (2008). 

Altering Nature. Vol. I: Concepts of ‘Nature’ and ‘The Natural’ in Biotechnology Debates. 

New York: Springer Publishing. 

68 American Association of University Professors. (1940). Statement of Principles on Academic 

Freedom and Tenure. Available at: http://www.aaup.org/AAUP/pubsres/policydocs/

contents/1940statement.htm. Consider also the discussion by Supreme Court Chief 

Justice Warren, in Sweezey v. New Hampshire, 354 U.S. 234 (1957), defending the 

academic freedom of a faculty member and recognizing the importance of new knowledge 

to civilization: “No field of education is so thoroughly comprehended by man that new 

discoveries cannot yet be made...Scholarship cannot flourish in an atmosphere of suspicion 

and distrust. Teachers and students must always remain free to inquire, to study and to 

evaluate, to gain new maturity and understanding; otherwise our civilization will stagnate 

and die.” Sweezey v. New Hampshire, 354 U.S. 234, 250 (1957).

69 See You, E.H., Supervisory Special Agent, Federal Bureau of Investigation. (2010). FBI 

Perspective: Addressing Synthetic Biology and Biosecurity. Federal Oversight of Synthetic 

Biology. Presentation to the Presidential Commission for the Study of Bioethical Issues, July 

9, 2010. Available at: http://www.bioethics.gov/transcripts/synthetic-biology/070910/federaloversight-of-synthetic-biology.html.

70 Berg, P., et al. (1975). Summary statement of the Asilomar conference on Recombinant DNA 

molecules. Proceedings of the National Academy of Sciences. 72(6);1981-1984 at p. 1981.

71 See, e.g., DHHS. (2009). Biosafety in Microbiological and Biomedical Laboratories, 5th 

Edition. Available at: www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf.

72 See You, E.H., op cit.

73 NSABB, op cit.; Patterson, A., op cit.

74 DHHS/NIH. (2009). NIH Guidelines for Research Involving Recombinant DNA Molecules. 

Available at: http://oba.od.nih.gov/rdna/nih_guidelines_oba.html.

75 NSABB, op cit., p.13.

76 Hart Research Associates, Synthetic Biology Project, Woodrow Wilson International Center 

for Scholars. (2010). Awareness & Impressions of Synthetic Biology: A Report of Findings 

Based on a National Survey among Adults. Available at: http://www.synbioproject.org/

process/assets/files/6451/_draft/hart_revised_.pdf. 
Analysis and Recommendations V

173

77 Framingham Heart Study. Ethics Advisory Board. Available at: http://www.

framinghamheartstudy.org/about/ethics.html.

78 NIH. Genome-Wide Association Studies (GWAS). Available at: http://grants.nih.gov/grants/

gwas/.

79 See, e.g., Office of Human Research Protections. (2010) Emergency Research Informed 

Consent Requirements. Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/

hsdc97-01.htm.

80 NSABB, op cit..

81 You, E.H., op cit.

82 The charter of the President’s Council on Bioethics instructed it “to provide a forum for a 

national discussion of bioethical issues.” See Kass, L. (2005). Reflections on public bioethics: 

A view from the trenches. Kennedy Institute of Ethics Journal 15(3):221-250; The National 

Bioethics Advisory Commission frequently recommended ongoing review and assessment 

of the topics it studied, with its reports contributing to such a process. See, e.g., National 

Bioethics Advisory Commission. (1999). Ethical Issues in Stem Cell Research. Available at: 

http://bioethics.georgetown.edu/nbac/pubs.html.

83 For additional information, see Research Councils of the United Kingdom. RCUK Public 

Engagement with Research Team. Available at: http://www.rcuk.ac.uk/per/default.htm.

84 Gutmann, A., and D. Thompson. (2002). Just deliberation about health care. In Ethical 

Dimensions of Health Policy. M. Danis, C. Clancy, and L. Churchill (eds). Oxford: Oxford 

University Press.

85 See, e.g., Sample, I. (2010). Craig Venter Creates Synthetic Life Form. Guardian. 20 May 

2010. Available at: http://www.guardian.co.uk/science/2010/may/20/craig-venter-syntheticlife-form.

86 Brenner, S., Senior Distinguished Fellow of the Crick-Jacobs Center, The Salk Institute. 

(2010). Reflections for the Future. Presentation to the Presidential Commission for the Study 

of Bioethical Issues, September 14, 2010. Available at: http://www.bioethics.gov/transcripts/

synthetic-biology/091410/reflections-for-the-future.html.

87 Caplan, A., op cit.; Kaebnick,, G., (2009) op cit.; Wheeler, S.E., op cit.; Mattson, I., Director, 

Macdonald Center for the Study of Islam and Christian-Muslim Relations, Director, Islamic 

Chaplaincy Program, and Professor of Islamic Studies and Christian-Muslim Relations, 

Hartford Seminary; and President, Islamic Society of North America. (2010). Philosophical 

and Theological Perspectives. Presentation to the Presidential Commission for the Study of 

Bioethical Issues, September 14, 2010. Available at: http://www.bioethics.gov/transcripts/

synthetic-biology/091310/philosophical-and-theological-perspectives.html; Wolpe, P., Asa 

Griggs Candler Professor of Bioethics and Director, Center for Ethics, Emory University. 

Ethics of Synthetic Biology. Presentation to the Presidential Commission for the Study of 

Bioethical Issues, July 9, 2010. Available at: http://www.bioethics.gov/transcripts/syntheticbiology/070910/ethics-of-synthetic-biology.html; Van den Belt, H. (2009). Playing God in 

Frankenstein’s footsteps: Synthetic biology and the meaning of life. Nanoethics. 3(3):257–

268; Dabrock, P. (2009). Playing God? Synthetic biology as a theological and ethical 

challenge. Systems and Synthetic Biology 3(1-4):47-54. 

88 FactCheck.org. Available at: http://factcheck.org/. 
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

174

89 The National Science Education Standards provides the following definition: “Scientific 

literacy means that a person can ask, find, or determine answers to questions derived from 

curiosity about everyday experiences. It means that a person has the ability to describe, 

explain, and predict natural phenomena. Scientific literacy entails being able to read with 

understanding articles about science in the popular press and to engage in social conversation 

about the validity of the conclusions. Scientific literacy implies that a person can identify 

scientific issues underlying national and local decisions and express positions that are 

scientifically and technologically informed. A literate citizen should be able to evaluate the 

quality of scientific information on the basis of its source and the methods used to generate 

it.” National Committee on Science Education Standards and Assessment, National Research 

Council. (1996). National Science Education Standards. Washington, DC: National 

Academies Press, p.22.

90 Ibid.

91 For additional information about these programs, see Synthetic Biology Engineering 

Research Center. Education. Available at: http://www.synberc.org/content/articles/education; 

see also The Synthetic Biology Project of the Woodrow Wilson International Center for 

Scholars. Available at: http://www.synbioproject.org/. 

92 For additional information, see BioEYES. What is BioEYES? Available at: http://www.

bioeyes.org/.

93 National Bioethics Advisory Commission. (1999). Research Involving Human Biological 

Materials: Ethical Issues and Policy Guidance. Rockville, Maryland. Page 74. Available at: 

http://bioethics.georgetown.edu/nbac/pubs.html.

94 See Endy, D., Terman Fellow and Assistant Professor of Bioengineering, Stanford University. 

(2010). Overview and Context of the Science and Technology of Synthetic Biology. 

Presentation to the Presidential Commission for the Study of Bioethical Issues, July 8, 2010. 

Available at: www.bioethics.gov/transcripts/synthetic-biology/070810/overview-and-contextof-the-science-and-technology.html.

95 Rawls, J. (1971). A Theory of Justice. Cambridge, Mass.: Harvard University Press.

96 Harmon, A. (2010). “Indian Tribe Wins Right to Limit Research of its DNA.” New York 

Times, April 21, 2010; and Couzin-Frankel, J. (2010). DNA returned to tribe, raising 

questions about consent. Science 328(5978):558.

97 45 C.F.R. § 46.111(a)(2).

98 Subcommittee on Environmental Justice, Environmental Health Policy Committee, DHHS. 

(1995). Special report: strategic elements for environmental justice. Environmental Health 

Perspectives 103(9):796-801.

99 Ibid.

100 Swiss Confederation, op cit. 

101 Grove, N.E., et al. (2010). The artemisinin enterprise: New sources of artemisinin to reduce 

economic barriers to ACT Access. Available at: http://www.oneworldhealth.org/img/

pdfdownloads/Artemisinin%20Enterprise.pdf. 
175

appendix

Guest Speakers
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

176

Bonnie L. Bassler, Ph.D.

Howard Hughes Medical Institute

Investigator; Squibb Professor, 

Department of Molecular Biology,

Princeton University; 

President, American Society 

for Microbiology

Jason Bobe, M.S.I.S.

Director of Community, Personal 

Genome Project, Harvard Medical 

School; Co-Founder, DIYbio.org

Sydney Brenner, M.D., D.Phil. 

Senior Distinguished 

Fellow of the Crick-Jacobs Center, 

The Salk Institute

Allen Buchanan, Ph.D.

James B. Duke Professor of Philosophy; 

Investigator, Institute for Genome 

Sciences and Policy, Duke University; 

Distinguished Research Associate, 

Uehiro Centre for Practical Ethics, 

University of Oxford

Arthur L. Caplan, Ph.D. 

Emmanuel and Robert Hart 

Director, Center for Bioethics;

Sydney D. Caplan Professor 

of Bioethics, School of Medicine,

University of Pennsylvania

Alexander M. Capron, LL.B. 

University Professor; Scott H. Bice 

Chair in Healthcare Law, Policy 

and Ethics; Professor of Law, 

Keck School of Medicine; 

Co-Director, Pacific Center for 

Health Policy and Ethics, 

University of Southern California

Robert Carlson, Ph.D.

Principal, Biodesic

George Church, Ph.D.

Professor of Genetics, 

Harvard Medical School

James J. Collins, Ph.D. 

University Professor; 

William F. Warren Distinguished 

Professor; Professor of Biomedical 

Engineering; Co-Director, 

Center for BioDynamics, 

Boston University; Investigator, 

Howard Hughes Medical Institute

Drew Endy, Ph.D.

Terman Fellow & Assistant Professor 

of Bioengineering, Stanford University; 

Director, BIOFAB: International Open 

Facility Advancing Biotechnology; 

President, The BioBricks Foundation

Ruth R. Faden, Ph.D. 

Director, Johns Hopkins Berman 

Institute of Bioethics; Philip Franklin 

Wagley Professor of Biomedical Ethics; 

Professor, Department of Health Policy 

and Management, Bloomberg School of 

Public Health; Professor, Department of 

Medicine, Johns Hopkins University 

Gregory Kaebnick, Ph.D.

Research Scholar, The Hastings Center; 

Editor, The Hastings Center Report

Nancy M.P. King, J.D.

Professor, Department of Social Sciences 

and Health Policy, Wake Forest University 

School of Medicine; Co-Director, 

Wake Forest University Center for 

Bioethics, Health, and Society
177

appendix: guest speakers

Ingrid Mattson, Ph.D. 

Director, Macdonald Center for 

the Study of Islam and 

Christian-Muslim Relations; 

Director, Islamic Chaplaincy Program;

Professor of Islamic Studies and 

Christian-Muslim Relations, Hartford 

Seminary; President, Islamic Society 

of North America 

Jonathan D. Moreno, Ph.D. 

David and Lyn Silfen University 

Professor; Professor, History and 

Sociology of Science; Professor, 

Philosophy; Professor of Medical Ethics, 

School of Medicine, 

University of Pennsylvania

Thomas H. Murray, Ph.D.

President, The Hastings Center

Bryan G. Norton, Ph.D. 

Distinguished Professor of Philosophy, 

School of Public Policy, 

Georgia Institute of Technology

Amy Patterson, M.D.

Acting Director, Office of Science 

Policy; Director, Office of Biotechnology 

Activities, National Institutes of Health

Kristala L.J. Prather, Ph.D.

Assistant Professor, Department 

of Chemical Engineering, 

Massachusetts Institute of Technology

Arti K. Rai, J.D. 

Elvin R. Latty Professor of Law,

Duke University School of Law; 

Member, Institute for Genome Science 

and Policy, Duke University

David Rejeski

Director, Science and Technology 

Innovation Program, Woodrow Wilson 

International Center for Scholars

David A. Relman, M.D. 

Thomas M. and Joan C. Merigan 

Professor of Medicine; Chief, Division 

of Infectious Diseases, Department 

of Medicine; Professor, Department 

of Microbiology and Immunology, 

Stanford University School of Medicine; 

Chief of Infectious Diseases, Veterans 

Administration Palo Alto Health Care 

System; Chair, Working Group on 

Synthetic Biology, National Science 

Advisory Board for Biosecurity

Randy D. Rettberg, M.S.

Director, iGEM and MIT Registry 

of Standard Biological Parts; 

Principal Research Engineer, 

Department of Biological Engineering, 

and Computer Science and Artificial 

Intelligence Laboratory, 

Massachusetts Institute of Technology

Michael Rodemeyer, J.D.

Lecturer, Department of Science, 

Technology & Society, 

School of Engineering and Applied 

Science, University of Virginia

Markus Schmidt, Ph.D. 

Co-founder, Organisation for

International Dialogue and Conflict 

Management, Vienna, Austria
NEW DIRECTIONS The Ethics of Synthetic Biology and Emerging Technologies

178

Allison Snow, Ph.D.

Professor, Department of Evolution, 

Ecology and Organismal Biology,

Ohio State University 

Ashley J. Stevens, D.Phil. 

Special Assistant to the Vice President 

of Research, Office of 

Technology Development;

Senior Research Associate, Institute 

for Technology Entrepreneurship and 

Commercialization, Boston University; 

President, Association of University 

Technology Managers

Damon A. Terrill, J.D., M.A.

Senior Vice President and General 

Counsel for International Legal and 

Regulatory Affairs, Integrated DNA 

Technologies; Member, International 

Gene Synthesis Consortium

Jim Thomas

Programme Manager, ETC Group

J. Craig Venter, Ph.D.

Founder and President, 

J. Craig Venter Institute

Ralf Wagner, Ph.D.

Chief Executive Officer and Chief Science 

Officer, Geneart AG; Professor and 

Chief, Molecular Microbiology 

and Gene Therapy, Institute of 

Medical Microbiology & Hygiene 

University of Regensburg; Member, 

International Gene Synthesis Consortium

David B. Weiner, Ph.D.

Professor, Department of Pathology and 

Laboratory Medicine; Chair, Therapy and 

Vaccines Program, CAMB, University of 

Pennsylvania; Chair, Scientific Advisory 

Board, Inovio Pharmaceuticals

Ron Weiss, Ph.D.

Associate Professor, Department 

of Biological Engineering and 

Department of Electrical Engineering 

and Computer Science, 

Massachusetts Institute of Technology 

Sondra E. Wheeler, Ph.D. 

Martha Ashby Carr Professor of Christian 

Ethics, Wesley Theological Seminary

Hugh Whittall

Director, Nuffield Council on Bioethics

Paul Root Wolpe, Ph.D.

Asa Griggs Candler Professor of Bioethics; 

Director, Center for Ethics, 

Emory University

Edward H. You

Supervisory Special Agent, 

Federal Bureau of Investigation, 

Weapons of Mass Destruction 

Directorate, Countermeasures Unit I, 

Bioterrorism Prevention Program

Presidential Commission for the Study of Bioethical Issues

1425 NewYork Avenue, Suite C-100

Washington, D.C. 20005

(202) 233-3960

www.bioethics.gov