Petr Jan Juračka / Photopedia Gel electrophoresis of nucleic acids.

Keeping Science in the Right Hands

Policing the New Biological Frontier

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Ongoing research and discoveries in the life sciences -- the latest and most promising involving synthetic biology -- have led to extraordinary advances that will benefit society. But criminals and terrorists could manipulate such advances to disrupt public safety and national security. Since its founding in 1923, Interpol has learned that the most effective way to keep up with a constantly changing world is by engaging law enforcement and consulting experts in its 190 member countries. Effective solutions to new global security threats require the exchange of information and intelligence. As the methods criminals employ have developed, so, too, has Interpol’s capacity for deploying new strategies and offering assistance to stop them.

To reduce the risks associated with the potential abuse of scientific developments, researchers and the policymakers in national governments and international entities responsible for the oversight of such research have to understand how criminals could use these emerging technologies. Through innovations in the field of synthetic biology, scientists can now design and engineer new biological parts, devices, and systems and redesign existing ones for other purposes. But there is always the possibility that a person with malicious intentions could co-opt those same innovations, which carry no inherent danger, and use them to cause harm. In response, Interpol has developed strategies to assist law enforcement and experts in the health and scientific communities in confronting this threat and raise awareness of the stakes of criminal exploitation.

As the world’s largest international police organization, Interpol knows from its past experience in combating cybercrime, the trafficking of illicit goods, maritime piracy, and other criminal activities that a strategy in one country is not necessarily right for another. Some countries have more advanced law enforcement methods and agencies; others have little or no synthetic biological activities to even regulate. Still, law enforcement officials around the world should learn how to gauge future threats and how to mitigate them and prepare for the consequences of a biological attack in a neighboring country or their entire region. A global policing strategy for dealing with synthetic biology should spread awareness of the potential threats but must not impede further scientific discovery.

A HISTORICAL PERSPECTIVE

The cutting-edge research field of synthetic biology combines elements of multiple scientific and engineering disciplines. It relies on chemically synthesized DNA to construct new biochemical production systems or organisms with novel or enhanced characteristics. Such innovations follow a half century of discovery that greatly expanded the knowledge of biological systems. Tremendous benefits have come from such research, such as more effective antibiotics. In 1953, James Watson and Francis Crick found that the building blocks of life are configured in a double-helix structure, a discovery that enabled scientists to gain a better grasp of biology at its most basic level. New techniques and better technologies have since been developed that allow scientists to understand how genes, or groups of DNA, function, interact, and control biological mechanisms.

Another innovation emerged in the 1970s, with genetic engineering, which made possible the manipulation and rearrangement of fragments of DNA from one or several organisms to produce new organisms with altered or new functions. In the middle of that decade, Paul Berg, a Nobel laureate, recognized and raised concerns about the potential safety of and ethical issues related to such scientific advancements. In 1975, he organized the Asilomar Conference on Recombinant DNA Molecules, which developed voluntary guidelines on implementing safety precautions for genetic engineering research, focusing primarily on the containment of research facilities.

The next big step in biotechnology took place between 1990 and 2003. At a cost of $2.7 billion, the United States funded and led the international Human Genome Project, which produced a database containing approximately three billion letters -- essentially the entire genomic sequence of one human being. Such a groundbreaking discovery has aided the treatment of many diseases; scientists have since identified more than 1,800 disease-related genes and developed more than 2,000 diagnostic tests and nearly 350 biotechnology-related products. DNA sequencing and improvements in the technology used to synthesize genes offer unprecedented scientific opportunities. Scientists have been able to artificially produce the genomes for diseases such as polio and the extinct 1918 Spanish flu, which killed an estimated 50 million people worldwide, allowing them to develop better vaccines to prevent future pandemics.

RISK REALIZATION

Increasingly rapid progress, however, can create new risks. The scientific benefits of synthetic biology and associated technological advancements have the potential for exploitation because of their “dual use” -- a term that refers to the way in which scientific material, procedures, and knowledge gained from beneficial research can be misappropriated for harmful purposes. Nuclear material, for example, can be used to generate electricity, but it can also be made into weapons of mass destruction. Synthetic biology can help produce better medicines and cleaner manufacturing proc­esses, but in criminal hands, it could also be used to intentionally modify an existing disease or create a novel, highly pathogenic biological agent.

In 2006, journalists from The Guardian ordered a small segment of the smallpox genome, which was modified to ensure its harmlessness, from a DNA synthesis company. At the time, the company did not realize what was being ordered and so did not ensure that the customer had a legitimate purpose for ordering the sequence; it shipped the material to a post office box for a little over $60, including postage. The reporting exercise revealed a gaping vulnerability. Policies and regulations simply cannot keep pace with scientific research and development, especially the risks associated with the potential dual use of synthetic biology and the resulting threats to national security. Terrorist and other criminal organizations around the world could benefit from this emerging vulnerability in order to perpetrate their malicious activities.

In addition, during the last few years, biological agents have increasingly been used in nefarious ways by individuals who did not belong to any specific terrorist or criminal organization. This worrying trend collides with the emerging concept of “do-it-yourself biology,” or DIYbio, an “open science” movement whose proponents believe that scientific innovation, technology, and research should be available to all inquiring minds, be they amateurs or professionals, inside or outside traditional research laboratories. Although DIYbio’s cross-disciplinary practitioners, including citizen scientists such as amateur bioengineers and biologists, have developed an operating principle of “no pathogens and no bioweapons,” this new context of scientific research and development could lead to an infinite variety of potential dual-use biotechnologies that could eventually be misused.

Fortunately, scientists at the forefront of the advances in synthetic biology are also helping lead the movement for its regulation. In 2009, the International Association Synthetic Biology and the International Gene Synthesis Consortium organized the first international scientific effort to address the potential risks. They created independent codes of conduct based on customer screening, gene-sequence screening, careful record keeping, and points of contact with law enforcement. The codes of conduct call for members to assess the risks posed by each new gene sequence manufactured, including by examining new sequencing data in the context of existing genetic databases and evaluating the national laws governing genes’ manufacture and distribution. Vendors must also vet potential buyers of gene sequences and the nature of the orders themselves. Suspicious orders are referred to as “hits.” This initiative encourages the industry to regulate itself and engage with other stakeholders in order to sustain the synthetic biology industry. It also highlights the need for law enforcement and the scientific community to work together to develop reporting mechanisms and mitigation strategies to prevent the misuse of biological material, technology, and expertise without restricting scientific progress.

The U.S. Department of Health and Human Services adopted these codes of conduct itself, implementing them on a national level in October 2010, at which time it issued customer- and sequence-screening guidelines for the sale of synthetic genes. If vendors become suspicious of an unusual order, they can contact the relevant law enforcement entity, such as the FBI’s local weapons of mass destruction coordinator. The moment a vendor contacts the FBI, someone can speak directly with a specialist who understands the science and the risks involved. So far, this alerting system has proved effective.

AN INTEGRATED RESPONSE

Interpol, meanwhile, is not new to the world of biological threats. Back in March 2005, it recognized that “there is no criminal threat with greater potential danger to all countries, regions and people in the world than the threat of bio-terrorism. And there is no crime area where the police generally have as little training as they do as in preventing or responding to bio-terrorist attacks.” This crucial lack of preparedness prompted Interpol’s creation of a capacity-building initiative, the Bioterrorism Prevention Program. This program has assisted almost all of Interpol’s member countries by raising awareness of biological threats and improving response capabilities and methodologies. Hundreds of law enforcement officials all over the world have participated in regional workshops, training courses, and exercises organized by the program to implement these efforts.

In 2010, Interpol established the CBRNE Terrorism Prevention Program (“CBRNE” stands for “chemical, biological, radiological, nuclear, and explosives”). To combat relevant threats, the program’s BioTerrorism Prevention Unit (BTPU) has developed a comprehensive strategy that consists of three main pillars. First, it analyzes intelligence and evaluates risks and threats in collaboration with law enforcement agencies and experts. Daily assessments of data gathered from open sources in the media, from member countries, and from such activities as conferences and publications contribute to the monthly INTERPOL CBRNE Intelligence Report. The BTPU supplies commentary and analysis based on available data and conducts further research with other key national bodies and international organizations. It produces a bulletin that provides Interpol’s member countries with a concise summary of the current global biological risks and threats.

Second, the BTPU focuses on the illegal acquisition, possession, development, and use of biological materials. It develops training programs and guidance documents for law enforcement officers, scientists, policymakers, regulators, and members of the private sector, including its Laboratory Security Manual and its Incident Response Guide. Through the unit, Interpol provides support, holds meetings, and organ­izes training to bolster regional and national biosecurity efforts. The BTPU also supports international agreements, such as the Biological Weapons Convention and UN Security Council Resolution 1540 -- which requires countries to secure their nuclear, chemical, and biological weapons -- that are designed to prevent the illegitimate and nefarious use of biological material, technology, and expertise.

Finally, the BTPU supports ongoing international investigations and other operations to detect, deter, and disrupt the illegitimate use of pathogens and toxins. It also provides operational support to Interpol’s international partners by helping establish procedures for dealing with new technologies, disease surveillance, amateur biology, and criminal or epidemiological investigations. In 2014, the BTPU will start focusing its efforts on a new initiative called Operation S3OMMET (Safe, Secure Surveillance of Microbiological Material and Emerging Technologies), a collaboration among Interpol, the International Federation of Biosafety Associations, and Connecting Organizations for Regional Disease Surveillance.

The key to reducing the risks associated with synthetic biology, Interpol believes, is to encourage governments, academia, health professionals, and law enforcement agencies to work together and understand the implications of the misuse of such advances in science and how to prevent it. To achieve that goal, six multidisciplinary workshops coordinated by Interpol in 2014, in Africa, the Middle East, the Asia-Pacific region, eastern Europe, South America, and East Asia, will bring together law enforcement officials, academics, biosecurity professionals, scientists, and health professionals. The workshops will address such current issues as laboratory safety and security but also teach participants how to tackle future threats, for example through the development of national disease surveillance strategies, and how to take further steps to reduce the risks associated with synthetic biology.

A GLOBAL RESPONSIBILITY

The misuse of synthetic biology and similar pioneering scientific technologies represents a multidimensional global threat that is becoming tomorrow’s reality. Therefore, it requires a coordinated international response. Interpol is playing a vital role in meeting this threat through its commitment to supporting law enforcement authorities around the world. But law enforcement is far from the only factor in this equation. The development of partnerships among all the relevant disciplines, especially between the scientific and research community and public health entities, is essential for a more efficient prevention-and-response strategy.

But science still must proceed unhindered. If biological research and the development of new scientific techniques are not allowed to progress, the very fabric of human existence could be affected. Diseases will continue to mutate, and without robust scientific research to produce better vaccines, human health could be endangered. Therefore, all nations should safeguard their sciences and ensure that future scientific developments generate significant advances for the good of all.

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