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Thursday, September 23rd, 2021

Pressing, multiplying biodefense issues plague U.S., experts say

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The Blue Ribbon Study Panel on Biodefense, a privately funded group established in 2014 to ascertain the current biodefense capabilities of the United States and issue expert recommendations to encourage change, has grown increasingly worried about microbial forensics and biological attribution.

And according to recent statements from several experts, it’s no wonder why.

“The diffusion of technical expertise coupled with the biotechnology revolution, drastically increases the threat of bioterrorism. New technologies have decreased resources and financial requirements for entry, and increased capabilities that could be misused by a determined bioterrorist. We need core microbial forensic laboratory capabilities to enable attribution,” said Dr. Gerald W. Parker, Jr., director of Texas A&M University’s Pandemic and Biosecurity Policy Program at the Scowcroft Institute for International Affairs and associate dean for Global One Health in the College of Veterinary Medicine.

Involved in biodefense since 1982, Parker recently told the panel that he feels like he has “been at the eye of the storm witnessing evolving biological threats over my career.”

“And today, I am more concerned than ever about the risk of biological threats—whether from outbreaks, accidents or attacks—and the need to underpin no-regret attribution decisions with a sound scientific foundation in microbial forensics,” Parker said during a panel meeting held earlier this month.

Attribution to determine who was responsible for an attack, whether a crime, act of terror, or warfare is essential to hold those responsible accountable for their actions, prevent future attacks and serve as a deterrent, he said.

Attribution and the supporting microbial forensic sciences also are important to exonerate and rule out suspected perpetrators, whether a nation state, terror group or criminal that is innocent, Parker said.

“The stakes could be very high, particularly when a nation state is involved or suspected, and a rush to judgment before the science and evidence are in, should be avoided,” said Parker. “Decisions to attribute, especially a nation state, will be consequential, no-regret decisions that must be guided by a strong scientific and evidentiary foundation.”

Online biocrimes
Essentially, microbial forensics and biological attribution are used to find out who, how and what disease agent was used, and where it was obtained following a biological attack.

And as biological threats and attacks increase worldwide, the risks are heightened for the United States, a fact the Blue Ribbon Study Panel on Biodefense has belabored since 2015 when it issued its national reform blueprint, which specifically includes Recommendation 9 saying the nation lacks biological attribution capabilities due to “the inherent challenges associated with microbial forensic techniques and related analyses.”

Today the panel continues advocating for the establishment of a national biological attribution decision-making process that would be overseen by the U.S. vice president; developed by the secretaries of the departments of State, Defense and Homeland Security (DHS), as well as the Attorney General and the Director of National Intelligence; and run by the Federal Bureau of Investigation (FBI), which also would be in charge of the National Bioforensics Analysis Center (NBFAC) where biological forensics and attribution work would be handled.

The panel is also concerned about U.S. President Donald Trump’s FY 2018 budget request, which would eliminate biological attribution and biodefense functions from DHS and close the National Biodefense Analysis and Countermeasures Center in Maryland, which houses the NBFAC.

“Terminating funding would leave the country without a core investigative tool for biocrimes and bioterrorism,” panel co-chairman and former Sen. Joseph Lieberman said.

Specifically, the NBFAC conducts technical analyses in support of federal law enforcement investigations and attempts to coordinate multi-agency biological forensic efforts. The NBFAC currently is administered by the DHS Science and Technology Directorate, which the panel says in its blueprint has caused NBFAC to struggle to coordinate with and serve other agencies “because its scientific goals sometimes run at cross-purposes to those of the operational communities it could serve.”

In addition to proposed budget cuts, the panel also is concerned about biothreats from virtual terrorists, who, like their offline counterparts, are tantalized by biological agents for several reasons: detection is tough, production is cheap, incubation periods allow ample get-away times, they’re simple to unleash, and common technology to produce and deliver warfare agents are readily available. Virtual terrorists now can gather online what’s needed to build deadly pathogens that may be used as weapons.

For instance, there’s the Clustered, Regularly Interspace, Short Palindromic Repeat (CRISPR) technique —a recent and significant scientific breakthrough that allows DNA code to be removed and replaced with new genes—that’s been used by virtual terrorists or even unknowing amateurs who can buy a cheap, online kit to reconstruct or edit DNA in their own makeshift synthetic biology labs.

Because CRISPR techniques now are “feasible for a greater range of users,” fears have increased that “in the wrong hands, the procedure could unleash dangerous strains of bacteria or other organisms,” explains Daniel Wagner, managing director of risk solutions at Risk Cooperative, in an Oct. 2 Huffington Post contributed piece.

“Prior to CRISPR, editing DNA required sophisticated labs, years of experience, a PhD degree, and many thousands of dollars,” Wagner writes. “Today the simple do-it-yourself CRISPR kits could enable virtual terrorists targeting the food supply chain to alter the avian influenza genome and engineer a large bird flu epidemic, similar to the 2009 H1N1 epidemic in Asia that affected not only poultry, but also other mammals, including human beings.”

And to properly and fully prosecute whomever committed such an act of bioterrorism, the U.S. must be able to rapidly and accurately identify the pathogens used, who used them and how.

The Blue Ribbon Study Panel held an Oct. 3 meeting, entitled Biological Attribution: Challenges and Solutions, to learn about the existing capabilities of the U.S. government to correctly identify pathogens and their sources; attribute the use of biological weapons with scientific and other forms of evidence; and explore the processes used for investigative, legal, policy, and political decisions involving biological attribution.

Clearly, after hearing from three experts who framed the problem for the biodefense panel, the prognosis wasn’t good.

In fact, panel member and meeting chairman Ken Wainstein, former U.S. Homeland Security Advisor and a partner in the litigation department at the Washington, D.C.-based Davis Polk and Wardwell LLP, called the experts’ statements “very illuminating and sobering.”

The nitty gritty
Specifically, the experts discussed biological threats and their potential for large-scale consequences, and how such threats and consequences have been and would be much worse because of an inability to obtain microbial forensic evidence. (The discipline of microbial forensics is based in epidemiology and focused on the characterization, analysis and interpretation of evidence from the scene of a bio-crime or an act of bioterrorism.)

Nicolas Dunaway, chief biosecurity officer at Inspirion Biosciences, previously oversaw weapons of mass destruction (WMD) investigations for the FBI and conducted liaison and outreach with public and private entities with a nexus to chemical, radiological, biological and nuclear material.

Dunaway has unique experience in computer network intrusion and computer network exploitation operations and has developed novel approaches for large-scale data management, bioinformatic analysis, biological warfare threat identification and information technology system development. He is also a subject matter expert on biological WMD matters, specifically select agents, synthetic biology and advanced biotechnology.

In providing panel members with examples about recent events, Dunaway generalized published research he had read about a hack that was conducted on a network system for a company that produced genetic sequences. The researchers showed that by sending a sequence of a certain type, they could compromise the code of the machines and take control of those machines, Dunaway told the panel.

“So instead of the typical hacks we see today … it demonstrates one of many, many issues we’re going to see with cyber and bio. Every time I see a cyber event, I think of an analogous bio event. I think that mindset is one we all need to start taking,” he said.

Edward H. You, a supervisory special agent in the biological countermeasures unit of the FBI Weapons of Mass Destruction Directorate, told the panel that attribution is also a major component needed in the nation’s overall biodefense strategy, regardless of whether bioterrorism events are accidental or intentional.

The FBI WMD Directorate was created in July 2006, consolidating WMD investigation and prevention efforts to create a unique combination of law enforcement authorities, intelligence analysis capabilities, and technical subject matter expertise focused on chemical, biological, radiological, nuclear and explosive matters, according to You.

In his position, You is responsible for creating programs and activities to coordinate and improve FBI and interagency efforts to identify, assess and respond to biological threats or incidents, and the efforts include expanding FBI outreach to the Life Sciences community to address biosecurity.

In a world of open-source DNA sequences, You told the panel that the potential for great discoveries in biology is nearly limitless, but so is the potential for exploitation, particularly as their associated costs decrease.

You noted that biological threat issues have historically been focused on the potential acquisition, development and use of materials such as viruses, bacteria and toxins. But new biotechnologies and the convergence of biology with the cyber/digital realm are challenging the nation’s current policies and practices to address biological threats.

“Public health, military labs, other nations … all of the stakeholders focused on this need to be connected in one way and we have to integrate these components. It will take leadership to do that,” You said. “We’re living in a perfect storm.”

Dunaway said he has “no idea” what to predict about challenges coming over the next year, except to say that the nation must remain involved and engaged.

“I expect genetic engineering will become more targeted, more capable. Tech will become more effective and more expansive. Should we ban/allow certain types of research? In my opinion, these types of advances are inevitable. Bans will serve only to take the U.S. out of leadership in this space and we’ll have national economic ramifications in security. And if you’re not in the field, you’re not having an effect on the game,” he said.

Facing reality
Members of the Blue Ribbon Study Panel on Biodefense tried to remain positive.

“We face some major challenges in microbial forensics and biological attribution, but we can overcome many of them,” said panel co-chairman and former U.S. Senate Majority Leader Tom Daschle. “We need to do what we can to eliminate them now, before we find ourselves under attack again.”

Wainstein said that he also hopes attribution is a national budget priority, particularly to maintain operations at national research labs and at NBFAC. “There are bioterrorism cases happening all the time. These aren’t just labs with the lights on and nothing’s happening. That’s a misconception that they’re just waiting for the next attack to come,” he said.

Lieberman said it’s critical for the United States to address the fact that the extraordinary expansion and advances in biotech can be used for adverse purposes.

“We’re dealing with a recurring human problem but inevitably governments and law have to try and intervene to protect people’s security,” Lieberman said. “This is an example of a problem our government has today due to partisan, ideological gridlock and rigidity and the inability to deal with budgeting in a rational way.

“It’s hard to get ahead of problems because [Congress] tends to only react when there’s a crisis. So what we’re working on here in this particular area … is to try to get ahead of this potential real threat before we have a crisis or a catastrophe,” he said.