[Federal Register Volume 75, Number 166 (Friday, August 27, 2010)]
[Notices]
[Pages 52752-52753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21359]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES


Request for Comments on Synthetic Biology

AGENCY: Department of Health and Human Services, Office of Public 
Health and Science, The Presidential Commission for the Study of 
Bioethical Issues.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Presidential Commission for the Study of Bioethical Issues 
is requesting public comment on the emerging science of synthetic 
biology, including its potential applications and risks, as well as 
appropriate ethical boundaries to assure that America reaps the 
benefits of this new technology.

DATES: To assure consideration, comments must be received by October 1, 
2010.

ADDRESSES: Individuals, groups, and organizations interested in 
commenting on this topic may submit comments by e-mail to 
[email protected] or by mail to the following address: Public 
Commentary, The Presidential Commission for the Study of Bioethical 
Issues, 1425 New York Ave., NW., Suite C-100, Washington, DC 20005.

FOR FURTHER INFORMATION CONTACT: Ms. Diane M. Gianelli, Director of 
Communications, The Presidential Commission for the Study of Bioethical 
Issues, 1425 New York Avenue, NW.,

[[Page 52753]]

Suite C-100, Washington, DC 20005. Telephone: 202/233-3960. E-mail: 
[email protected]. Additional information may be obtained by viewing 
the Web site: http://www.bioethics.gov.

SUPPLEMENTARY INFORMATION: On November 24, 2009, the President 
established the Presidential Commission for the Study of Bioethical 
Issues to advise him on bioethical issues generated by novel and 
emerging research in biomedicine and related areas of science and 
technology. The Commission is charged to identify and promote policies 
and practices that assure ethically responsible conduct of scientific 
research, healthcare delivery, and technological innovation. In 
undertaking these duties, the Commission will identify and examine 
specific bioethical, legal, and social issues related to potential 
scientific and technological advances; examine diverse perspectives and 
possibilities for dynamic international collaboration on these issues, 
and recommend legal, regulatory, or policy actions as appropriate.
    As its first order of business, the Commission has begun an inquiry 
into the emerging science of synthetic biology. The President asked the 
Commission to address this topic on May 20, 2010, following the 
announcement that the J. Craig Venter Institute had successfully 
engineered a synthetic cell--the insertion into a bacterium of a 
complete, functional genome synthesized entirely from a digitized 
sequence that replaced the native genome of the host over a series of 
replications. Daniel G. Gibson et al., Creation of a Bacterial Cell 
Controlled by a Chemically Synthesized Genome, Science Express (May 20, 
2010). The President charged the Commission to consider any potential 
medical, environmental, security, and other benefits, as well as any 
related risks. Additionally, the President asked the Commission to 
develop ``recommendations about 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.'' The Commission will 
report back its finding and recommendations later this year.
    To begin its work, the Commission convened a public meeting in 
Washington, DC on July 8-9, 2010. At that meeting, representatives with 
expertise in science, ethics, and public policy, as well as advocates 
with diverse perspectives on this new field provided information and 
insight to help guide the Commission in its thinking. Leading 
scientists in the field created context for the discussion by 
explaining the state of the science and discussing possible 
applications. Among the anticipated benefits discussed were employing 
bacterial cells as microscopic factories in the production of 
pharmaceuticals and biofuels.
    Additionally, with regard to potential risks, the Commission heard 
discussion about possible biosafety, biosecurity and environmental 
concerns, including risks that may arise as synthetic biology relies on 
organisms that can evolve and self-replicate, and existing practices to 
protect against these risks. The Commission also heard discussion about 
ethical boundaries and the views of faith communities.
    As the approaches to, and applications of, synthetic biology 
proliferate, the Commission wishes to develop a multifaceted 
understanding of its scientific and technological implications, and 
learn more about the views of the public on the existing or potential 
ethical and social ramifications. To this end, the Commission is 
inviting interested parties to provide input and advice through written 
comments. Among other issues, the Commission is interested in receiving 
comments on the potential benefits that the emerging field of synthetic 
biology is likely to yield, now or in the future, the risks that may 
arise, the ethical boundaries that should be considered, and policies 
and strategies to assure that the public will benefit from these new 
tools and products.
    Please address comments by e-mail to [email protected], or by mail 
to the following address: Public Commentary, The Presidential 
Commission for the Study of Bioethical Issues, 1425 New York Ave., NW., 
Suite C-100, Washington, DC 20005. Comments will be publicly available, 
including any personally identifiable or confidential business 
information that they contain. Trade secrets should not be submitted.

    Dated: August 17, 2010.
Valerie H. Bonham,
Executive Director, The Presidential Commission for the Study of 
Bioethical Issues.
[FR Doc. 2010-21359 Filed 8-26-10; 8:45 am]
BILLING CODE 4154-06-P