Synthetic Biology

Synthetic biology is a field of science that involves redesigning organisms for useful purposes by
engineering them to have new abilities. Synthetic biology researchers and companies around the
world are harnessing the power of nature to solve problems in medicine, manufacturing and
agriculture.

What can synthetic biology do?

Redesigning organisms so that they produce a substance, such as a medicine or fuel, or gain a new
ability, such as sensing something in the environment, are common goals of synthetic biology
projects. Some examples of what scientists are producing with synthetic biology are:
• Microorganisms harnessed for bioremediation to clean pollutants from our water, soil and
air.
• Rice modified to produce beta-carotene, a nutrient usually associated with carrots, that
prevents vitamin A deficiency. Vitamin A deficiency causes blindness in 250,000 - 500,000
children every year and greatly increases a child's risk of death from infectious diseases.
• Yeast engineered to produce rose oil as an eco-friendly and sustainable substitute for real
roses that perfumers use to make luxury scents.

What is the difference between synthetic biology and genome

editing?
In some ways, synthetic biology is similar to another approach called "genome editing" because
both involve changing an organism's genetic code; however, some people draw a distinction
between these two approaches based on how that change is made. In synthetic biology, scientists
typically stitch together long stretches of DNA and insert them into an organism's genome. These
synthesized pieces of DNA could be genes that are found in other organisms or they could be
entirely novel. In genome editing, scientists typically use tools to make smaller changes to the
organism's own DNA. Genome editing tools can also be used to delete or add small stretches of
DNA in the genome.
Can you synthesize an organism's entire genome?
Can researchers synthesize an organism's entire genome? The answer to this question is yes, and it
has already been done. In 2002, scientists in the United States synthesized a viral genome for the
first time. Viral genomes are much smaller compared to the genomes of most bacteria and
microorganisms. Scientists showed that it was possible to create the polio virus from scratch and
brought attention to the risk that synthetic biology could be used to develop biological weapons.
While this group of researchers did not intend to cause harm with their research, their work
understandably raised concerns that bad actors might use synthetic biology for malicious purposes.
Please see the "What are the ethical and social implications?" section of this resource to learn about
the federal regulations in place to regulate so-called "dual use research of concern", or research that
could be directly misapplied to pose a significant threat to public health and safety, agricultural
crops and other plants, animals, the environment, or national security.
The first synthetic bacterial genome was completed in 2008 with the synthesis of the genome
of Mycoplasm genitalium, a bacterium that can cause urinary and genital tract infections in humans.
In 2017, another group of scientists partially synthesized the genome of Saccharomyces cerevisiae,
the yeast that is used to make bread and brew wine and beer.
Today, researchers are continuing to push the limits of existing DNA-synthesis technology to help
understand how genomes work. One group of researchers, called the "Genome Project-Write" (GP-
Write)", is seeking to synthesize, or "write" whole genomes from human cell lines and the genomes
of other plants and animals important to agriculture and public health. The name of their project is a
play on the Human Genome Project (HGP). In 2003, scientists working on the HGP sequenced, or
"read", the more than 3 billion DNA letters, or base pairs, that make up the human genome. One of
the leading motivations for GP-Write is to stimulate innovation in DNA synthesis technologies
through the proposed research. Importantly, the research in GP-Write involving human genomes
will occur only in cells and no human embryos will be used in this research.
What are the ethical and social implications?
Projects that propose to synthesize entire genomes raise important ethical questions about potential
harms and benefits to society. Many of the ethical questions relevant to synthetic biology are similar
to ethical discussions related to genome editing. Are humans crossing moral boundaries by
redesigning organisms with synthetic biology techniques? If synthetic biology yields new
treatments and cures for diseases, who in our society will have access to them? What are the
environmental impacts of introducing modified organisms into the ecosystem? Such ethical
questions have been the subject of research since the beginning of the HGP and will continue to be
researched as technology evolves and changes. Most scientists, ethicists and policymakers agree
that entire societies must discuss and weigh the potential harms and benefits of synthetic biology in
order to answer these questions. Leading voices in bioethics, including the Presidential Commission
for the Study of Bioethical Issues and the National Academies of Sciences, Engineering and
Medicine, have expressed the importance of public engagement and dialogue in the governance of
emerging synthetic biology and genome editing technologies.
As the synthesis of the polio virus demonstrates, there are also biosecurity concerns related to
synthetic biology. The US government's Federal Select Agents Program regulates the possession of
high-risk infectious agents like polio for research and other purposes. Additionally, federally-funded
research, such as research supported by the National Institutes of Health (NIH) that involves high-
risk infectious agents, is subject to additional oversight and risk management as laid out by the Dual
Use Research of Concern (DURC)policy. For more information about the biosecurity policies that
NIH has in place, please visit this website. More broadly, the federal government has a policy in
place, called the Coordinated Framework for Regulation of Biotechnology, to oversee the
introduction of synthetic biology products into the market.
For additional resources about the ethics, governance and societal implications of synthetic biology,
please refer to the following websites and publications:

Resources Related to the Ethical and Social Implications of Synthetic Biology:

• Biodefense in the Age of Synthetic Biology (National Academies of Sciences, Engineering,
and Medicine)
• Human Genome Editing: Science, Ethics, and Governance (National Academies of Sciences,
Engineering, and Medicine)
• New Directions: The Ethics of Synthetic Biology and Emerging Technologies (Presidential
Commission for the Study of Bioethical Issues)