International Judicial Monitor
Published by the International Judicial Academy, Washington, D.C., with assistance from the
American Society of International Law

Winter 2014 Issue

Global Judicial Dialogue


Synthetic Biology:  A Legal Frontier

Judge Susan A. EhrlichBy: Susan A. Ehrlich, J.D., LL.M. (biotechnology & genomics); Judge (ret.), Arizona Court of Appeals

Synthetic biology seemingly is an oxymoron, making artificial what is natural, but actually it is an important new discipline with the extraordinary promise to make better every aspect of life.  But an adequate jurisdictional and regulatory context is lacking, largely because these legal constructs were written for known organisms, and thus arises a host of unaddressed legal issues. 

The phrase “synthetic biology” was first known to be used by the French biologist Stéphane Leduc in 1912 to refer to the creation of artificial life.  Nearly 100 years later, in 2005, Drew Endy described “synthetic biology” as “engineering biology” or thinking about organisms in an engineering context, biology as information.  Synthetic biology later was defined by the Royal Academy as “aim[ing] to design and engineer biologically based parts, novel devices and systems as well as redesigning existing, natural biological systems” and contemporaneously defined by the Synthetic Biology Engineering Research Center (SynBERC), of which Dr. Endy is a director, as:

… the design and construction of new biological entities such as enzymes, genetic circuits, and cells or the redesign of existing biological systems.  …  The element that distinguishes synthetic biology from traditional molecular and cellular biology is the focus on the design and construction of core components (parts of enzymes, genetic circuits, metabolic pathways, etc.) that can be modeled, understood, and tuned to meet specific performance criteria, and the assembly of these smaller parts and devices into larger integrated systems that solve specific problems.

Advances likely will include genomes and cells that use non-natural components such as non-standard nucleotides and non-genetically encoded amino acids. 

The lack of a singular definition reflects that “synthetic biology” does not refer to a specific technology as much as it refers to a diversity of enabling technologies and approaches.  Researchers include not only those engaged in what may be considered the traditional life sciences, biology and biochemistry as examples, but chemists, materials scientists, engineers and computer modelers or, in other words, individuals from multiple scientific and engineering professions.  Their purpose is to understand the nature of living organisms, the organisms’ forms and functions, and to use that understanding both to redesign natural biological systems and to design and build new biological parts, devices and systems for improved and/or novel purposes. 

The potential of synthetic biology is unlimited, but a short list of what is underway includes:

  1. Helping agriculture feed a growing world population with fewer resources by developing crops that can better withstand environmental adversity such as drought, heat, flooding and salt; improving the disease and pest resistance of plants; increasing the nutritional content of food; and advancing land-management practices for efficient, less-wasteful and sustainable use and for conservation.

  2. Bettering the environment by developing biofuels from engineered microbes that convert plentiful, renewable resources into diesel, ethanol or hydrogen; formulating alternatives to petroleum-based products; engineering organisms to detect and eliminate contaminants in air and water; treating wastewater; bioremediation, and reducing trash as well as turning trash into commodities such as plastic that itself can be recycled.

  3. Improving health, and providing greater safety and security.

    Amyris scientists created microbial strains that produce artemisinic acid, a precursor of the potent anti-malarial drug artemisinin.  The company then agreed with Sanofi-Aventis to license the technology, royalty-free, for the purpose of manufacturing artemisinin-based drugs to treat malaria. 

    Adam Arkin (University of California – Berkeley) is studying microbial inflammation in Crohn’s Disease. 

    Harvey Lodish (MIT) is researching laboratory-made red blood cells that will get rid of a virus in the course of the cells’ natural development.

    Douglas Melton (Harvard University) is working on perfecting a process of programming stem cells to replace the glucose-sensing and insulin-producing cells that are lost in those who have Type 1 diabetes. 

    Novartis scientists synthesized the genomes of a new strain of flu virus and within a week determined the best design for a vaccine.  If executed on a large scale, a process of vaccine development that now takes so long that the peak of an outbreak can pass will become timely.

    Ron Weiss (MIT) is investigating the production of organ tissues that can be used for medical and pharmaceutical research.

    Producing morphine from yeast, thereby replacing the trade in opium poppies.

    Deriving only the beneficial ingredients from marijuana, eliminating the   psychoactive components.

    Engineering bio-responsive nano-materials for use in diagnostics and in the        delivery of drugs.

    Detecting and defending against biological and chemical threats. 

The lists suggest that the growth of synthetic biology seemingly is unequaled except by the computer industry.  Not surprisingly, the business is estimated by SynBERC to approach $16 billion by 2016.

Concomitant with the extraordinary advances and promised benefits are the dangers posed by synthetic biology because of its dual-use potential, that is its capability for use for malevolent as well as benevolent purposes.[1]  Those with criminal or terrorist intent can employ the advances of synthetic biology to threaten public health, safety and security.  Existing pathogens or toxins can be modified to create novel, highly dangerous tools of terror, and the menace is as likely, if not more likely, to come from a single individual or a group of individuals as from a nation-state.  Indeed, the increasing ease and decreasing cost of 3-D printing could make it possible for a malefactor to design a genetic sequence on a computer, send the plan to a 3-D “bio-printer” loaded with nucleotides, and generate a lethal virus.  The code can be hidden in an innocuous transmission, the computer can be at a far-distant location, and the printer can be at yet a third, remote site.  

How well does the current regulatory system for biological products address the introduction of products manufactured by synthetic biology?  How satisfactory are our legal systems in providing rules and oversight?

The United States regulatory posture is a pieced quilt of laws, guidelines and policies, each with a different focus and span.  The U.S. approach largely is regulation by element and/or product and not by process, so there is neither a particularly clear nor a cohesive approach, and such authorities and procedures as exist are divided among a plethora of government agencies, some of which have overlapping jurisdiction.   

The European Union’s approach is premised more on process than product, and the E.U. takes a precautionary attitude as stated in “Communication from the [European] Commission on the precautionary principle,” Communication 2000/0001 (final), a detailed document from which the following quotations are only snippets:

The Commission considers that the Community, like other [World Trade Organization] members, has the right to establish the level of protection ― particularly of the environment, human, animal and plant health ― that it deems appropriate.  Applying the precautionary principle is a key tenet of its policy … .



*  *  *

Recourse to the precautionary principle presupposes that potentially dangerous effects deriving from a phenomenon, product or process have been identified, and that scientific evaluation does not allow the risk to be determined with sufficient certainty.

*  *  *

The Community has consistently endeavoured to achieve a high level of protection, among others in environment and human, animal or plant health. In most cases, measures making it possible to achieve this high level of protection can be determined on a satisfactory scientific basis.  However, when there are reasonable grounds for concern that potential hazards may affect the environment or human, animal or plant health, and when at the same time the available data preclude a detailed risk evaluation, the precautionary principle has been politically accepted as a risk management strategy in several fields.

Additionally, while not directed at products of synthetic biology, E.U. Regulation 428/2009 puts stringent limits on the export, trade or transfer of a host of materials, excepting “basic scientific research” and information already “in the public domain.”  This regulation applies to technical knowledge also. 

The Biological and Toxin Weapons Convention is pertinent howsoever a benign organism is converted into a dangerous one.  From Article 1:

Each State Party to this Convention undertakes never in any circumstances to develop, produce, stockpile or otherwise acquire or retain:

(1) Microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes … .

Further, the International Association Synthetic Biology and the International Gene Synthesis Consortium together wrote codes of conduct based on customer screening, order screening, detailed record-keeping and the maintenance of close associations with law-enforcement agencies.  The U.S. Department of Health and Human Services also has guidelines for customer- and sequence-screening for sales of synthetic genes.  In part, these actions were responses to The Guardian journalists who in 2006 successfully ordered a segment of the smallpox genome from a DNA-synthesis company.  Earlier, researchers at the State University of New York at Stony Brook had made a living polio virus, and other researchers had re-created the deadly Spanish flu virus. 

The various approaches, even if not directly applied to synthetic biology, give rise to the question whether there are organisms that should not be synthesized.  Governments already have decided that certain pathogens and toxins require a high level of security and/or should not be shared, but in the context of synthetic biology, are there those that should not be created?  In that same context, can such organisms even be defined?  If so, as decided by whom or by what institution? 

In reality, regulation is a response to risk assessment, the identification of potential hazards or harmful outcomes, a determination of the probability of the occurrence of the hazard and a management plan.  Among the regulatory tools are funding controls, the issuance of permits and licenses, transfer and trade restrictions, labeling requirements, and legal guidelines and laws. 

The National Institutes of Health, the largest funder of scientific research in the United States, and an entity within the Department of Health and Human Services, changed its NIH Guidelines for Research Involving Recombinant DNA Molecules to NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. It divided agents into categories of “risk groups” based on a calculation of the likelihood of an agent’s “ability to cause disease in humans and the available treatments for such disease.”  Often, compliance with the NIH Guidelines is the prerequisite for federal funding, but the application of these Guidelines is limited as its title suggests.  Most of the other U.S. Government agencies such as the Department of Agriculture, the Food and Drug Administration and the Environmental Protection Agency also have regulations that arguably are applicable to categories of synthesized organisms, but, again, each focus is particular and each scope is narrow. 

It is a common suggestion that synthesized organisms be required to be “bar-coded” as some already are, meaning that the organism is tagged with a unique DNA sequence.  This would facilitate the tracing of an accidental or negligent release, although the practice still would not be employed by a criminal or terrorist. 

To require that the organism must be synthesized such that it cannot replicate outside a defined environment or that it be unable to exchange functional genes with another organism would serve to protect the environment should there be an unfortunate release.  Monitoring compliance is the difficulty – as is true of a bar-code requirement. 

The lurking menace of regulation is the degree to which it is not commensurate with the risk so that compliance will unnecessarily burden investigators and stifle scientific research.  In the context of synthetic biology, however, the additional jeopardy is that of confusion because the regulatory construct by and large addresses known organisms, and the jurisdictional and regulatory environment is ambiguous.

One of the most problematic issues is that of intellectual property, that is how to implement an approach that is fair and yet reasonable in cost. 

The Registry of Standard Biological Parts is a collection of thousands of standardized “parts” called BioBricks, which are DNA sequences with specific functions that that can be combined to build synthetic biology devices and systems.  The BioBricks Foundation sets the standards to make these parts widely available.  Elsewhere, I have suggested a tiered system with such parts as the free library at the base.  Above that, in a closed but not limited system, the holder of the patent or license that accompanies such “products” would establish the terms of use, starting with a nominal fee for academic research and scaling up for a company according to the size of and use by the company.  Always the terms of use would include regulatory compliance, and there would be an administrative overseer to monitor compliance and arbitrate disputes.  The fee would be less than what amount could be obtained in the open market, but the benefits would be having the products disseminated more readily because of the shared terms and therefore more widely, and from the use of other such products for a reduced fee. 

Then there is the matter of our values.  There is the organic farmer whose profits have disappeared because of the proximity of his or her crop to synthetically modified plants, but this has to be balanced against blanket applications of insecticide or the use of less water and fertilizer as examples.  There is the laborer whose job has vanished because a synthetic medicinal agent, spice, herb, flavoring or fragrance has replaced what he or she harvested, but what if the continual harvesting of that item devastated a forest or what if the synthesized product will save or improve lives or provide more jobs?  Artemisinin provides a case on point; the synthetic version has deprived growers of sweet wormwood of their livelihood, but because of the quantity that can be synthesized, tens of thousands of children will be saved from the horrors of malaria. 

Synthetic biology has established itself as a vital new discipline, offering solutions to some of the world’s most intractable problems.  Ultimately, though, it is our collective responsibility to educate ourselves so as to ensure that these technologies are developed in a manner consistent with our values and with our priorities as reflected in our laws. 

[1] In 2012, the United States Government issued its “Policy for Oversight of Life Sciences Dual Use Research of Concern.”  “Life sciences” was defined to include synthetic biology.  In its Policy, the U.S. Government denominated a subset of dual-use research as dual-use research of concern (DURC), which it defined as “research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.” 


ASIl & International Judicial AcademyInternational Judicial Monitor
© 2014 – The International Judicial Academy
with assistance from the American Society of International Law.

Editor: James G. Apple.
IJM welcomes comments, suggestions, and submissions.
Please contact the IJM editor at