In March 2007, the Homeland Security Today cover report, Viral Visions, explored emerging concerns over disturbing new developments in synthetic genomics and biological research that provide the potential for new and lethal designer pathogens. Deadly pathogens that can be created virtually from scratch.

In late November, the Department of Health and Human Services took the first step toward imposing controls on the synthetic genomic industry in the form of guidelines for companies to follow to screen for suspicious orders for customized DNA sequencing placed by companies and individuals.

Because of post-9/11 concerns over bioterrorism, the National Science Advisory Board for Biosecurity (NSABB) was charged with identifying the potential biosecurity issues raised by the ability to synthesize “Select [controlled biological] Agents” and providing advice on whether current government policies and regulations adequately cover the de novo synthesis of these Select Agents. The panel’s report, Addressing Biosecurity Concerns Related to the Synthesis of Select Agents, was formally transmitted to the government in March 2007.

The NSABB determined that the technology “employed in the field of synthetic genomics to create sophisticated live vaccines and to discover new therapeutics for infectious diseases ... can be misused to generate dangerous pathogens de novo that are subject to oversight, thus circumventing the extant regulatory framework for controlling the possession and use of such organisms.”

“This dichotomy illustrates the dual use nature of synthetic genomics and underscores the need to develop strategies to address the possibility that knowledge and technologies emanating from vitally important biological research will be misused to threaten public health or national security,” the report determined.

“In this regard,” the NSABB report concluded, “rapid advances in DNA synthesis technology and the open availability of pathogen genome sequence data have raised concerns in the scientific community and general public regarding the possible use of this technology and information to generate biological agents that could threaten public health, agriculture, plants, animals, the environment, or material. Special concern has been voiced about the use of this technology to generate Select Agents de novo.

Continuing, the report stated that “while traditional recombinant DNA technology has raised similar or related concerns, approaches based on de novo synthesis avoid any need for access to the naturally occurring agents or naturally occurring nucleic acids from these agents, and greatly expand the potential availability of these agents. The National Science Advisory Board for Biosecurity has been charged with identifying the potential biosecurity concerns raised by the ability to synthesize Select Agents and providing advice on whether current United States Government policies and regulations adequately cover the de novo synthesis of Select Agents or whether additional biosecurity measures are necessary.”

The NSABB Working Group on Synthetic Genomics’ assessed the adequacy of the current regulatory framework to safeguard against the misuse of this science and made recommendations to address their concerns. The recommendations were approved by the NSABB on October 25, 2006.

“Toward this end,” on November 27, the Office of the Assistant Secretary of Preparedness and Response (ASPR) within the Department of Health and Human Services issued the Notice of proposed rulemaking, “Screening Framework Guidance for Synthetic Double-Stranded DNA Providers.” ASPR is the lead agency in a broad interagency process to draft the guidance stemming from the NSABB’s recommendations.

The Notice stated that “technologies that permit the directed synthesis of polynucleotides, which underlie synthetic biology and more specifically synthetic genomics, could enable individuals not authorized to possess [physical biological] Select Agents to gain access to them through their de novo synthesis. Such synthesis obviates the need for access to the naturally occurring agents or naturally occurring genetic material from these agents, thereby greatly expanding the potential availability of these agents.”

The draft voluntary guidelines for the gene and genome synthesis industry explained that “synthetic biology, the developing interdisciplinary field that focuses on both the design and fabrication of novel biological components and systems as well as the re-design and fabrication of existing biological systems … is not constrained by the requirement of using existing genetic material. Thus, technologies that permit the directed synthesis of polynucleotides have great potential to be used to generate organisms, both currently existing and novel, including pathogens that could threaten public health, agriculture, plants, animals, the environment, or material.”

In order “to reduce the risk that individuals with ill intent may exploit the commercial application of nucleic acid synthesis technology to access genetic material derived from or encoding Select Agents or Toxins, the US Government has developed recommendations for a framework for synthetic nucleic acid screening” to identify suspicious intent on the part of purchasers of synthetic genomic products from commercial suppliers, the Notice stated.

The proposed rulemaking “is intended to provide guidance to producers of synthetic genomic products regarding the screening of orders so that these orders are filled in compliance with current US regulations and to encourage best practices in addressing potential biosecurity concerns.”

The Notice declared that “the US Government acknowledges that there are synthetic nucleic acid sequences from non-Select Agents or Toxins that may pose a biosecurity concern,” and therefore “the primary goal in developing guidance for synthetic nucleic acid providers is to minimize the risk that unauthorized individuals or individuals with malicious intent will gain access to toxins and organisms of concern through the use of nucleic acid synthesis technologies.”

The CIA began worrying in earnest about designer pathogens soon after the October 2001 anthrax attacks provided evidence indicating the anthrax had been weaponized. An expert panel was convened to study the problem and to make an assessment of the seriousness of a synthetic viral threat.

Following an outcry from some of the scientists it empanelled to study the issue, the CIA Intelligence Directorate’s Office of Transnational Issues quietly released a short, unclassified synopsis of the academician’s November 2003 report, The Darker Bioweapons Future. The report concluded that the “growing understanding of the complex biochemical pathways that underlie life processes has the potential to enable a class of new, more virulent biological agents engineered to attack distinct biochemical pathways and elicit specific effects.”

Although the two-page abstract provided no details concerning the expertise, equipment and facilities required to develop engineered pathogens, nor a time estimate for how long the development process might take, more than five years later the CIA—and other IC components —continue watching developments very carefully.

Indeed. Synthetic bio- threats are carefully being monitored by American intelligence authorities and bio-weapons experts. And apparently there’s reason for them to be more concerned than they were more than two years ago when the Viral Visions report noted that the ability of individuals to create frightening new viruses in their basements was rapidly growing.

Last May the Wall Street Journal tackled the problem in the story, In Attics and Closets, 'Biohackers' Discover Their Inner Frankenstein.

Under the subhead, Using Mail-Order DNA and Iguana Heaters, Hobbyists Brew New Life Forms, the report highlighted that “do-it-yourselfers tinker with the building blocks of life in the comfort of their own homes.” The report asked whether these “biohackers [pose] a threat to national security?”

The report quoted “a senior official in the FBI's Weapons of Mass Destruction Directorate saying the bureau is working with academia and industry to raise awareness about biosecurity, ‘particularly in light of the expansion of affordable molecular biology equipment’ and genetic databases.”

A variety of federal officials who had expressed these same concerns to Homeland Security Today more than two years ago recently reiterated their worries to HSToday.us, pointing to the very sorts of home basement virology labs that were described in the Wall Street Journal report.

“The ability to create nasty pathogens like your hybrid rabies virus in your bathroom is becoming easier and easier,” one of the authorities said [see the HSToday.us Kimery Report, Zombies, Rabies and Synthetic Genomics]. The official was referring to the description of a synthetic virus in the Viral Visions report – a highly contagious “designer” rabies virus that not only makes the victim mad, but mad enough to want to run around biting people.

In the world of synthetic hybrid pathogens, zombies are “possible,” a virologist who helps the Intelligence Community keep track of the work being done in the field of synthetic genomics had earlier told Homeland Security Today.

“The emergence of this field is driven by recent advances in the underlying technology of commercial DNA synthesis that allow biologists to produce and assemble segments of DNA quickly and cheaply with almost perfect accuracy,” wrote John Dileo in a MITRE publication report.

“While the synthesis of small segments of DNA has been possible for two decades, the use of these early techniques to produce a genome (the complete blueprint, in the form of DNA, for the construction of an organism) would have required years of work and been prohibitively expensive,” Dileo continued. But today “DNA production and assembly techniques have advanced to the point that a medium-sized virus can now be constructed in weeks. In addition, these improvements have led to a rapid increase in the number of companies that offer whole gene synthesis. The resulting competition has lowered prices to within the budgets of most researchers.”

Several years earlier, in the paper, A Practical Perspective on DNA Synthesis and Biological Security, published in Nature Biotechnology, the authors stated that “few developments have leapfrogged over predecessor technology as quickly and extensively as synthetic biology. Based on cutting-edge DNA synthesis technology, synthetic biology has already fueled an expansion of opportunities in biological engineering, with advanced capabilities that surpass those provided by traditional recombinant DNA technology.”

But while “synthetic biology promises vast improvements to our well-being and our understanding of the living world,” the paper’s authors cautioned, they also pointed out that “like any powerful technology, DNA synthesis has the potential to be misused. In the wrong hands, the new capabilities enabled by synthetic biology could give rise to both known and unforeseeable threats to our biological safety and security.”

And “current government oversight of the DNA synthesis industry falls short of addressing this unfortunate reality,” the authors warned.

The group of academics who authored the paper called “for the immediate and systematic implementation of a tiered DNA synthesis screening process.”

“In order to establish accountability at the user level,” they wrote, “individuals who place orders for DNA synthesis would be required to identify themselves, their home organization, and all relevant biosafety level information.”

It's just that sort of information the federal government wants the synthetic genomics industry to collect and scrutinize when fulfilling orders for customized DNA sequencing.

Seeing the scores of companies that pop up under the Google search, “customized DNA sequencing,” and it’s easy to understand the concern and reasoning behind the proposed rulemaking.