The Bush administration is ramping up bioterrorism research that will press beyond traditional defenses against natural biowarfare germs to explore genetically engineered superbugs, as well as the means to mass-produce and disseminate them.
After spending almost $10 billion on biodefense research, defense scientists say broader studies of bioterror threats are needed to weigh the chances of certain attacks, tell U.S. intelligence what to look for and shore up defenses.
A classified presidential directive and other documents offer a roadmap for the new research as part of the first effort at coordinating all federal biodefense research since the October 2001 anthrax attacks by mail.
"Mother Nature has created a number of nasty pathogens," said Gerald Parker, head of science-based threat analysis and response for the U.S. Department of Homeland Security. "But we have to be worried about the future, too, and worry about comprehensive threats."
"As a country, that's a set of areas that could stand to have more investment," agreed Pat Fitch, chief of the chemical and biological national security program at Lawrence Livermore Laboratory.
The rapid spread and dropping costs of basic biotechnology raise the specter that terrorists eventually will tinker with naturally deadly germs to make them more virulent, impervious to drugs or tough to detect. But is it a real threat? Is it likely enough that the United States needs to develop special vaccines, antidotes and detectors to thwart it?
"You don't want to spend most of your money on a threat that no one can (deliver on) unless they have a weapons program that is just massive," said Livermore's Fitch.
"It's just such a hard nut to crack," he said.
So is slowing the spread of bioweapons worldwide, and arms-control advocates worry the secrecy of the Bush administration's plans could hamstring the 1972 global ban in bioweapons development. They say biologists in China, Russia and rogue nations will gain a new argument for secretly studying new germs and delivery methods under the rubric of biodefense.
"If any other country set forth a program like this, U.S. intelligence undoubtedly would call it an offensive program," said Edward Hammond, head of the Sunshine Project, a group in Austin, Texas, that tracks bioweapons and biodefense issues.
"Our enemy now is not the Russians or Saddam. It's biotech itself. It's imagining what we can do to fight the technology," he said. "If you generate that mentality, it's sort of no-holds barred."
Three experts in biological arms control recently published an essay questioning the Department of Homeland Security's plans for biothreat-assessment research, to be based at the Army's Fort Detrick in Frederick, Md., but likely to use scientists and labs nationwide, Lawrence Livermore among them.
Milton Leitenberg, a veteran arms control advocate and senior scholar at the University of Maryland's Center for International and Security Studies, wrote the essay, and it was signed by retired Ambassador James Leonard, chief negotiator of the Biological Weapons Convention for the Nixon administration, and by Richard Spertzel, a former Army bioweapons scientist and chief U.N. bioweapons inspector in Iraq after the first Gulf War.
The critique was triggered by a February presentation to military officers about the Homeland Security Department's new National Biodefense Analysis and Countermeasures Center. Among research thrusts, it tasked scientists to study how to "acquire, grow, modify, store, stabilize, package (and) disperse" bioweapons and to run computer simulations of large-scale production.
It called for "red teaming" operations, in which scientists would figure out how to execute terrorist attacks.
The Department of Homeland Security's Parker said scientists need answers to biothreat questions even about the six Class A threat agents. The toxin produced by Clostridium botulinum is the most poisonous substance known, lethal in microgram quantities in food, water or the air.
But scientists aren't sure how much terrorists would have to produce from germ's seven different serotypes to create mass casualties in a U.S. city. That probably means lab studies on animals to gauge effects on humans, Parker said.
"That piece of information may be necessary to help bound the problem, to understand whether a terrorist would need to develop a cupful or several hundred kilograms," he said.
Leitenberg said gene-splicing germs or testing animals with clouds of pathogens alone don't necessarily worry him.
"All of these taken together, that's something to worry about," he said.
From 1969, when the United States ended its offensive bioweapons program, until at least the mid-1980s, the Defense Department considered those activities outlawed by the Biological Weapons Convention.
The 1972 treaty forbids development, manufacture and stockpiling of germs "for hostile purposes." At the insistence of the United States and the former Soviet Union, the treaty does not mention "research" and allows biological work that is "prophylactic, protective or for peaceful purposes." That created a gray area for biodefense because it employs many of the same scientific techniques and equipment used to develop bioweapons.
Lacking unambiguous proof, nations judge intentions by inference: Does a suspect nation have large fermenters, dryers or milling machines? Are its scientists splicing new genes into pathogens? Do they have aerosol chambers for releasing clouds of germs and exposing vaccinated animals to highly virulent pathogens? Are they studying delivery methods?
The United States has accused eight nations of running bioweapons programs, based largely on evidence of genetic engineering of pathogens and possession of equipment for studying production and delivery methods. Looking at the administration's new biodefense strategy, other nations may make the same judgment of the United States, bolstering arguments by their own defense scientists for more aggressive biological research.
If we found these things elsewhere in countries we were suspicious of, we would not say they had a necessary biodefense program, said Leitenberg.
During the Clinton administration, the CIA, the Defense Threat Reduction Agency and the Defense Intelligence Agency launched several classified, code-name projects that pushed into the gray zone: the making of a Soviet-era biological bomblet and studies of gene shuffling to produce deadlier germs (Clear Vision); building a small anthrax factory out of commercial off-the-shelf parts (Project Bacchus); the development of a vaccine-resistant superstrain of anthrax (Project Jefferson.)
Some of the projects, first reported by the New York Times in September 2001, were never cleared by the Clinton White House.
The answer, say critics of the administration's biodefense plans, is transparency and oversight. By opening biodefense facilities and their research to public scrutiny, dangerous or unnecessary work is less likely to occur, and the defensive nature of the work will be clear to other nations.
Livermore's Fitch said his scientists already publish as much of their research as possible, and Parker said the new research effort will go further, with internal and external review panels approving both open and classified work.