Shanghai American School Pudong Model United Nations 2015
Forum:
Economic and Social Council
Issue:
Implementing standards and regulations for synthetic biology
Student Officer: Ruby Zhou
Position:
President of the Economic and Social Council
Introduction
The past few years have seen an enormous leap in the emerging field of innovative sciences,
particularly synthetic biology. A highly innovative and novel field, synthetic biology involves the
application of engineering techniques to the biological components of an organism. Biotechnology, when
explored and employed ethically, could be revolutionary to the basic understanding of life on Earth. In
addition, it holds enormous medical potential in finding cures for diseases and genetic disorders, as well
as environmental challenges such as oil spills and the use of finite fossil fuels. Despite synthetic
biology’s potential benefits, synthetic biology also raises a myriad of concerns regarding the safety of
genetically engineered organisms, as well as controversies regarding the ethics of artificial life.
Synthetic biology is a highly volatile field as it is so advanced that current technology struggles to
estimate the potential risks. If left unregulated, synthetic biology could have serious adverse affects on
biodiversity and existing ecosystems. This topic requires delegates to have an adequate grasp of the
fundamentals of basic biology, as well as a thorough understanding of closely related topics such as
bioethics and biosafety. It is imperative that strict regulations and solid infrastructure are created and
implemented to reap the benefits of synthetic biology, while ensuring the safety of the public and
preserving the morality of human innovation.
Definition of Key Terms
Synthetic biology
Synthetic biology is a field that combines many disciplines including but not limited to:
biotechnology, molecular biology, evolutionary biology, biophysics, and computer engineering. A
rapidly developing and evolving field, the definition of synthetic biology continues to be debated
among scientists. However, it can be understood as the physical application of engineering
principles to fundamental biology. The traits of all living organisms are coded within their DNA,
also known as the genetic code, or genome of an organism. Although the alteration of DNA has
been in practice for many years, such as in the processes of selective breeding and genetic
modification, biotechnologists have only recently started progressing towards creating completely
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artificial DNA. Today, there are two major approaches related to the experimentation of synthetic
biology, which are “in vivo” and “in vitro.” The “in vivo” approach involves reducing the genome of
an organism to the basics of life, then adding synthesized DNA, while the “in vitro” approach
involves assembling a completely artificial organism from scratch. Synthetic biology is employed
in a variety of projects and experiments such as the creation of artificial life, information storage,
designed organic molecules, and the production of biosensors. In addition to technological and
scientific challenges, synthetic biology raises a myriad of ethical and security concerns. Certain
security concerns include the incorrect usage of new technologies towards creating harmful
pathogens and biological warfare, while ethical concerns include moral issues regarding the
creation and conscious design of new life forms.
Bioethics
Bioethics is the study and discussion of possible ethical and moral issues that may arise
accompanying new advancements in biology, medicine, and other sciences. It is a broad field
that deals with controversial issues such as the limits of life (abortion, euthanasia), organ
donation and transfer, and the creation of new life. With the rapid development of biotechnology,
bioethics has expanded to include issues such as cloning, genetic design of human fetuses, and
the unnatural prolongation of life. Bioethics and synthetic biology are two complexly
interconnected fields.
Biotechnology
Biotechnology is the usage of biological knowledge to develop technology that could result in the
creation of useful products, which includes the field of synthetic biology. Biotechnology covers the
expanse of everything from genetically modified crops and sustainable energy to vaccines and
foods that require a fermentation process. Scientific discoveries regarding biotechnology employ
natural biological processes to solve the problems of modern society. For example, biological
processes that harness catalysts such as enzymes, yeast, and other microorganisms are helping
to reduce environmental footprint in ways including but not limited to: streamlining the
manufacturing process of chemicals, reducing the reliance on petroleum products, and using of
biofuels to reduce green house gases and counter the effects of global warming.
Genetically Modified Organisms (GMOs)
A genetically modified organism is an organism with genetic material that has been altered
through genetic engineering to increase is efficiency, functionality, or benefits. It involves the
deliberate mutation, insertion, or deletion of genes from the genetic sequence of an organism.
The most widespread usage of GMOs is the modification of crops such as corn and soybeans to
increase yield production and nutritional value. There are numerous arguments both for and
against GM crops. While genetically modified crops are often resistant to pest damage, diseases,
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environmental conditions, and chemicals, they could also be potentially dangerous. Some
potential dangers include cross contamination between GM and non-GM crops, hidden allergens,
as well as the effect that large-scale GM crop production could have on small scale, sustainable
farming. Though GM crops have been widely adopted, controversies remain unresolved.
Synthetically Modified Organisms (SMOs)
A synthetically modified organism (SMO) is vastly different from a Genetically Modified Organism
(GMO), although the two are commonly confused. While GMOs cover the expanse of organisms
whose naturally occurring genomes have been altered, but not artificially created, SMOs contain
DNA that is 100% synthesized, meaning that its genetic sequence cannot be found in nature.
Precautionary Approach
Principle 15 of the Rio Declaration on Environment and Development states that: “In order to
protect the environment, the precautionary approach shall be widely applied by States according
to their capabilities. Where there are threats of serious or irreversible damage, lack of full
scientific certainty shall not be used as a reason for postponing cost-effective measures to
prevent environmental degradation.” The precautionary approach, which is sometimes referred to
as the precautionary principle, simply means that when an action has a suspected risk of being
harmful, the burden of proof falls upon those taking the action in the absence of scientific
consensus that indicates otherwise. Such an approach has been prevalent in many UN
documents including the Rio Declaration, the Kyoto Protocol, and the Cartagena Protocol on
Biosafety. It is a conservative measure to ensure that volatile and novel scientific findings do not
adversely affect the public.
History
From understanding to creating genes
The first usage of the term “synthetic biology” can be traced back to 1912, when Stephane
Leduc, a French biologist, published a book titled La Biologie Synthétique. In his book, Leduc expressed
and advocated his opinion that in order to gain a thorough understanding of natural scientific
phenomena, one must be able to reproduce such phenomena in a controlled setting. Although numerous
scientists in Leduc’s time strove to apply his concept to the field of biology, they were ultimately
unsuccessful due to their limited knowledge regarding the basics of genetics.
The discovery of DNA
Following the discovery of DNA’s double helix structure by Watson and Crick in 1953, and
the subsequent revolution in the field of genetics that followed, scientists were able to finally
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apply Leduc’s concept to the field of evolutionary and molecular biology. In 1973, three scientists
(Stanley Cohen, Rudolf Jaenisch, and Beatrice Mintz), employed restrictive enzymes to introduce
artificial DNA into a bacterium, creating the first organism containing synthesized DNA. This was
followed by the historically significant moment in which scientists at the University of Edinburgh
successfully cloned the first mammal- Dolly the sheep. Following these developments, many
discoveries were made, vastly expanding the scientific community’s knowledge of genetics.
Developments in the 21st century
In recent years, with the increasing availability of DNA synthesizing technology, research and
experimentation in synthetic biology have become much more accessible. Gene sequencing, which once
took decades and billions of dollars, can now be done for only thousands, and in a much shorter time. In
addition, scientists have been able to gain a more thorough knowledge of the natural biological
organization of organisms through advancements in the exploration of genetics. Although great progress
has been made, scientists, the public, and governments of nations have slowly come to realize the
uncertainties that have arisen from rapid advancements in the field of synthetic biology.
Synthetic biology and healthcare
Synthetic biology has shown incredible potential to be beneficial to healthcare. Scientists
in recent years have perfected the production of synthetic insulin, which is crucial in the treatment
of diabetes. This eliminates the need to use animal pancreases in order to obtain insulin.
Scientists are also experimenting with synthesized human cells that could potentially battle
cancer internally and manipulate human cells to intercept fatal allergic reactions.
Key Issues
Confusion surrounding synthetic biology
Due to the novelty and complexity of synthetic biology, much of the public remains unaware and
uninformed about the field. The multitude of concerns that this generates allows for the irresponsible
abuse of newly developed technologies, as well evasion of existing regulations. Terms that exist
intertwined within the field of synthetic biology are often misunderstood or incorrectly defined, such as
the matter of Genetically Modified Organisms (GMOs), Living Modified Organisms (LMOs), and
Synthetically Modified Organisms (SMOs). In order to effectively understand this issue, clear definitions
of relevant technical terms must be produced and internationally accepted to standardize the processes
of the industry.
Possible risks
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Synthetic biology seeks to apply the basic practices of engineering to the fundamentals of life
sciences. Unlike altering the genetic material of organisms, synthetic biology seeks to create living
organisms with completely synthesized DNA. While this could prove to be monumental in medical and
environmental advancements, it is also an area of great uncertainty, posing many ethical controversies
and safety concerns.
Ethical concerns
Synthetic biology raises many concrete and philosophical ethical issues. Firstly, there
remains doubt regarding the innate value of synthetic biology and its potential. Further research
must be conducted to determine if the potential benefits of biotechnology outweigh the potential
adverse effects it could have on public health and well being, as well as whether the
advancements of synthetic biology justify its economic cost. Secondly, the creation of artificial life,
with 100% synthesized genetic material, poses questions about the fundamentals of life forms
and evolution. Finally, if synthetic biology is to be developed and utilized, steps must be taken to
ensure that the products resulting from new technology are not exploited for profit or to harm the
public. Developments in synthetic biology also raise questions regarding intellectual property and
its infringement. In the process of creating organisms from completely synthesized DNA,
standards must be proposed regarding the process that allows one to patent products from
synthetic biology.
The threat of deliberate misuse
As with any new form of technology, the development of synthetic biology will eventually
allow for the deliberate creation of organisms that could prove to be harmful. Advancing
technology has now allowed for the biological components of organisms to be designed to
perform certain tasks. As synthetic biology progresses, there will no doubt be a possibility that
harmful bacteria, viruses, and pathogens could be produced, which puts basic human welfare at
risk. Regulatory legislation must be put into effect to counter the risks of biological weapons and
biological warfare.
Environmental and biological concerns
In addition to ethical and security concerns, synthetic biology also raises a number of
environmental concerns. In the absence of scientific evidence, it is difficult to determine whether
the products of synthetic biology will have a detrimental effect on natural ecosystems and existing
biological diversity. It is impossible to estimate the risks associated with introducing artificially
created life into natural ecosystems, and the effect it will have on the existing structure of living
organisms.
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Major Countries and Organizations Involved
The United States of America (US)
The United States of America is a global leader in the field of synthetic biology. Along with an
annual federal investment of $140 million towards synthetic biology research, the US government has
shown its dedication in addressing the ethical controversies and security concerns of the field. In 2010,
after the creation of the first complete, living cell with 100% synthetic DNA, President Obama directed
the Presidential Commission for the Study of Bioethical Issues to review the field and to outline ethical
guidelines aimed at minimizing the safety risks of synthetic biology. Upon completion, the Committee
came up with a list of five basic ethical principles to serve as guidelines for future regulation: public
beneficence, responsible stewardship, intellectual freedom and responsibility, democratic deliberation,
and justice and fairness. However, although there have been many recommendations and outlines
towards regulation, there remains a lack of solid, enforced infrastructure in the rapidly developing field.
Experts have also noted that due to the unique structure of the US legislative branch, and lack of public
interest, there is little motivation for tangible legislation regulating synthetic biology to be introduced.
Germany
Home to numerous biotechnology companies, as well as many research institutions and
programs dedicated to synthetic biology, there is no doubt that Germany is a forerunner in synthetic
biology. Germany’s robust engineering industry, combined with its historical strength in biology and
chemistry, only contribute to its strength in the development of biotechnology. Synthetic biology could
prove to be of enormous economic advantage to the nation, as indicated by the German Research
Foundation (DFG), Germany’s national academy of science, the Leopoldina, as well as the German
Academy of Science and Engineering. However, Germany has also expressed its hesitations regarding
the potential risks that inevitably accompany advancements in biotechnology. This is an especially
controversial and sensitive topic, given the country’s history with abuse of bioscience in the 19th century,
combined with Germany’s existing ban on genetically modified crops and strict limitations on embryonic
stem cell research.
China
China, a rapidly developing country with flourishing economy, is actively seeking to be a global
leader in the field of synthetic biology. According to Xian-en Zhang, Director General of the Basic
Research Department of China’s Ministry of Science and Technology, this effort is motivated by the
nation’s desire to address public health issues, as well as a continued desire to promote the
advancement of science and technology. Recently, several organizations within the country have
expressed their support for research within the field, including the Chinese Academy of Science, the
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Chinese Academy of Engineering, as well as numerous regional and federal organizations. There has
also been an increase in budget allocations towards synthetic biology, with annual funding now
accounting for 2% of China’s national GDP. As biotechnology ushers in a new era of advancements for
the country, it is imperative that China addresses the legal, ethical, and security issues before it.
The International Association Synthetic Biology (IA-SB)
The International Association Synthetic Biology (IA-SB) is a coalition of biotech companies based
in Germany with the main goal of advancing and developing the field of synthetic biology. Established in
2007 by six German companies, it has since then expanded to 10 member companies from numerous
countries such as Germany, the United Kingdom, the United States, and Australia. Despite its largely
corporate nature, the IA-SB has expressed its concern regarding the ethical and security issues that
synthetic biology raises, and is in favor of the creation and implementation of regulatory infrastructure.
They have initiated many projects towards the safe practice and development of synthetic biology
includes, including enormous progress towards self-regulation. The “Code of Conduct for Best Practice
in Gene Synthesis,” which was finalized in November of 2009, provides an extensive framework of
regulations regarding important aspects of the industry such as DNA sequence screening, customer
screening, and ethical gene synthesis. It has since then been adopted by the members of the IA-SB, as
well as several other companies from around the world.
Timeline of Events
Date
1912
1973
October 1, 1990
Description of event
First recoded usage of the term “synthetic biology” in Leduc’s book La Biologie
Synthétique.
First recombinant DNA organisms appear. The following year, Jaenisch and
Mintz (1974) create the first transgenic mouse.
The Human Genome Project is launched by the National Human Genome
Research Institute (NHGRI)
The Cartagena Protocol on Biosafety comes into effect. The aim of the Protocol
May 15, 2000
is to protect biodiversity from potential dangers that may arise from the creation
of genetically modified organisms through synthetic biology.
Letters containing anthrax are circulated in the United States postal system,
October, 2001
causing several fatalities. This event highlighted the potential threat of biological
warfare.
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June 12, 2002
The United States Congress signs the Public Health Security and Bioterrorism
Preparedness Act into effect.
April, 2003
The Human Genome Project is completed.
2005
The Alfred P. Sloan Foundation launches the Synthetic Biology Initiative to “to
identify the risks associated with research in, and applications of, synthetic
biology and to assess the ethical, regulatory, and public policy implications of
these risks.”
April, 2007
The International Association Synthetic Biology (IA-SB) is formed from six
German gene-synthesis companies.
June, 2007
The European Union (EU) launches the NEST Pathfinder Initiative to conduct
cross-disciplinary research on key principles relating to the field of synthetic
biology.
December, 2010
The Presidential Commission for the Study of Bioethical Issues releases “New
Directions: The Ethics of Synthetic Biology and Emerging Technologies,” a
report that provides recommendations for regulating synthetic biology.
May, 2014
Scientists (Denis A. Melyshev et al.) create the first living organism with two
entirely synthetic strands of DNA.
Relevant UN Treaties and Events

The Cartagena Protocol on Biosafety, September 11, 2003

A/RES/56/599, International convention against the reproductive cloning of human beings, 26
November 2001

S/RES/1540, Convention against the proliferation of weapons of mass destruction, 28 April 2004
Previous Attempts to Solve the Issue
Due to the fact that many of the controversies surrounding the safety of synthetic biology mirror
those that surround the previously debated issue of genetically modified organisms (GMOs), much has
already been done in attempting to solve the issue. On the issue of genetic engineering, extensive and
varying infrastructures have been implemented in the international community to regulate the process of
altering an organism’s DNA. The Cartagena Protocol on Biosafety, an international agreement to protect
biodiversity from potential synthetic biology threats, has been signed by 167 United Nations member
States, Niue, the State of Palestine, as well as the European Union. The Protocol employs a
“precautionary approach” to ensure that the results of developing biotechnology will not have detrimental
effects on existing biological diversity, human, and public health.
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Numerous parties and member States have undertaken extensive research projects to better
understand the complex field of synthetic biology. In the US, The Presidential Committee for the Study of
Bioethical Issues was established in 2009 within the US Department of Health and Human Services. In
December of 2010, the Committee published its extensive report with detailed recommendations and
outlines for the regulation of synthetic biology. The US is not alone is this effort, and SYNBIOSAFE and
COSY, which are both European funded projects, are two such examples. SYNBIOSAFE has released
numerous reports on managing the risks of synthetic biology. Alternatively, COSY focuses specifically on
familiarizing the public with the concept of synthetic biology.
Despite the amount of extensive research that has occurred on the topic, there remains much to
be done regarding the implementation of solid, regulatory infrastructure regarding synthetic biology.
Possible Solutions
In order for new advancements in synthetic biology to be beneficial, regulations must be crafted
and implemented on a national and international level. The safety of biotechnology must be ensured and
the moral and ethical concerns surrounding the field must be addressed. When formulating plausible
solutions to the issue at hand, delegates must keep in mind the ultimate goal of mitigating the safety and
ethical concerns that may arise, while harnessing the novel technology of synthetic biology for beneficial
and practical applications.
Much of the volatile experimentation involving synthetic biology evades regulatory action due to
the vagueness of definitions surrounding the topic. To address this, it is of the utmost importance that a
universally accepted definition of what constitutes “synthetic biology” is established, as well as any
products and commodities that may stem from biotechnology.
One major challenge to the regulation of synthetic biology is the confusion between Genetically
Modified Organisms (GMOs) and completely synthesized organisms (SMOs). In order to prevent evasion
from regulation, the difference between the two must be clearly distinguished.
To address the threat of synthesized viruses and bacteria that may be potentially harmful to the
public, delegates must take care to employ a precautionary approach. Regulations and infrastructure of
the utmost rigidity must be implemented to prevent the abuse and exploitation of biotechnology and to
prevent the occurrence of biological warfare. Nations must take care to provide protocols in the case of
biological warfare, and implement precautionary measures to ensure the well being of citizens.
Finally, to address the ethical side of the issue, delegates must collaborate between member
States an agreement to adhere to the same moral standards in continued experimentation involving
synthetic biology. Delegates must discuss and advocate for, on behalf of their member states,
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controversies such as the usage of synthetically engineered commodities, as well as the future of
synthetic biology such as the alteration of the human genome.
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