The Secretive Fight Against Bioterror/ Custom-Built Pathogens Raise Bioterror Fe

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Aug 2, 2006 3:40 AM

The Secretive Fight Against Bioterror/ Custom-Built Pathogens

Raise Bioterror Fears

 

 

The Secretive Fight Against Bioterror

 

The government is building a highly classified facility to research

biological weapons, but its closed-door approach has raised concerns.

By Joby Warrick

Washington Post Staff Writer

Sunday, July 30, 2006; A01

 

On the grounds of a military base an hour's drive from the capital,

the Bush administration is building a massive biodefense laboratory

unlike any seen since biological weapons were banned 34 years ago.

 

The heart of the lab is a cluster of sealed chambers built to contain

the world's deadliest bacteria and viruses. There, scientists will

spend their days simulating the unthinkable: bioterrorism attacks in

the form of lethal anthrax spores rendered as wispy powders that can

drift for miles on a summer breeze, or common viruses turned into

deadly superbugs that ordinary drugs and vaccines cannot stop.

 

The work at this new lab, at Fort Detrick, Md., could someday save

thousands of lives -- or, some fear, create new risks and place the

United States in violation of international treaties. In either case,

much of what transpires at the National Biodefense Analysis and

Countermeasures Center (NBACC) may never be publicly known, because

the Bush administration intends to operate the facility largely in secret.

 

In an unusual arrangement, the building itself will be classified as

highly restricted space, from the reception desk to the lab benches to

the cages where animals are kept. Few federal facilities, including

nuclear labs, operate with such stealth. It is this opacity that some

arms-control experts say has become a defining characteristic of U.S.

biodefense policy as carried out by the Department of Homeland

Security, NBACC's creator.

 

Since the department's founding in the aftermath of the Sept. 11

attacks, its officials have dramatically expanded the government's

ability to conduct realistic tests of the pathogens and tactics that

might be used in a bioterrorism attack. Some of the research falls

within what many arms-control experts say is a legal gray zone,

skirting the edges of an international treaty outlawing the production

of even small amounts of biological weapons.

 

The administration dismisses these concerns, however, insisting that

the work of NBACC is purely defensive and thus fully legal. It has

rejected calls for oversight by independent observers outside the

department's network of government scientists and contractors. And it

defends the secrecy as necessary to protect Americans.

 

" Where the research exposes vulnerability, I've got to protect that,

for the public's interest, " said Bernard Courtney, NBACC's scientific

director. " We don't need to be showing perpetrators the holes in our

defense. "

 

Tara O'Toole, founder of the Center for Biosecurity at the University

of Pittsburgh Medical Center and an adviser to the Defense Department

on bioterrorism, said the secrecy fits a larger pattern and could have

consequences. " The philosophy and practice behind NBACC looks like

much of the rest of the administration's philosophy and practice: 'Our

intent is good, so we can do whatever we want,' " O'Toole said. " This

approach will only lead to trouble. "

 

Although they acknowledge the need to shield the results of some

sensitive projects from public view, critics of NBACC fear that

excessive secrecy could actually increase the risk of bioterrorism.

That would happen, they say, if the lab fosters ill-designed

experiments conducted without proper scrutiny or if its work fuels

suspicions that could lead other countries to pursue secret biological

research.

 

The few public documents that describe NBACC's research mission have

done little to quiet those fears. A computer slide show prepared by

the center's directors in 2004 offers a to-do list that suggests the

lab will be making and testing small amounts of weaponized microbes

and, perhaps, genetically engineered viruses and bacteria. It also

calls for " red team " exercises that simulate attacks by hostile groups.

 

NBACC's close ties to the U.S. intelligence community have also caused

concern among the agency's critics. The CIA has assigned advisers to

the lab, including at least one member of the " Z-Division, " an elite

group jointly operated with Lawrence Livermore National Laboratory

that specializes in analyzing and duplicating weapons systems of

potential adversaries, officials familiar with the program confirm.

 

Bioweapons experts say the nature of the research envisioned for NBACC

demands an unusually high degree of transparency to reassure Americans

and the rest of the world of the U.S. government's intentions.

 

" If we saw others doing this kind of research, we would view it as an

infringement of the bioweapons treaty, " said Milton Leitenberg, a

senior research scholar and weapons expert at the University of

Maryland's School of Public Policy. " You can't go around the world

yelling about Iranian and North Korean programs -- about which we know

very little -- when we've got all this going on. "

 

Creating the Weapons of Terrorism

Created without public fanfare a few months after the 2001 anthrax

attacks, NBACC is intended to be the chief U.S. biological research

institution engaged in something called " science-based threat

assessment. " It seeks to quantitatively answer one of the most

difficult questions in biodefense: What's the worst that can happen?

 

To truly answer that question, there is little choice, current and

former NBACC officials say: Researchers have to make real biological

weapons.

 

" De facto, we are going to make biowarfare pathogens at NBACC in order

to study them, " said Penrose " Parney " Albright, former Homeland

Security assistant secretary for science and technology.

 

Other government agencies, such as the Centers for Disease Control and

Prevention, study disease threats such as smallpox to discover cures.

By contrast, NBACC (pronounced EN-back) attempts to get inside the

head of a bioterrorist. It considers the wide array of potential

weapons available. It looks for the holes in society's defenses where

an attacker might achieve the maximum harm. It explores the risks

posed by emerging technologies, such as new DNA synthesizing

techniques that allow the creation of genetically altered or man-made

viruses. And it tries in some cases to test the weapon or delivery

device that terrorists might use.

 

Research at NBACC is already underway, in lab space that has been

outsourced or borrowed from the Army's sprawling biodefense campus at

Fort Detrick in Frederick. It was at this compound that the U.S.

government researched and produced offensive biological weapons from

the 1940s until President Richard M. Nixon halted research in 1969.

The Army continues to conduct research on pathogens there.

 

In June, construction began on a $128 million, 160,000-square-foot

facility inside the same heavily guarded compound. Space inside the

eight-story, glass-and-brick structure will be divided between NBACC's

two major divisions: a forensic testing center tasked with using

modern sleuthing techniques to identify the possible culprits in

future biological attacks; and the Biothreat Characterization Center,

or BTCC, which seeks to predict what such attacks will look like.

 

It is the BTCC's wing that will host the airtight, ultra-secure

containment labs where the most controversial research will be done.

Homeland Security officials won't talk about specific projects planned

or underway. But the 2004 computer slide show -- posted briefly on a

Homeland Security Web site before its discovery by agency critics

prompted an abrupt removal -- offers insight into NBACC's priorities.

 

The presentation by NBACC's then-deputy director, Lt. Col. George

Korch, listed 16 research priorities for the new lab. Among them:

 

" Characterize classical, emerging and genetically engineered pathogens

for their BTA [biological threat agent] potential.

 

" Assess the nature of nontraditional, novel and nonendemic induction

of disease from potential BTA.

 

" Expand aerosol-challenge testing capacity for non-human primates.

 

" Apply Red Team operational scenarios and capabilities. "

 

Courtney, the NBACC science director, acknowledged that his work would

include simulating real biological threats -- but not just any threats.

 

" If I hear a noise on the back porch, will I turn on the light to

decide whether there's something there, or go on my merry way? "

Courtney asked. " But I'm only going to do [research] if I have

credible information that shows it truly is a threat. It's not going

to be dreamed up out of the mind of a novelist. "

 

Administration officials note that there is a tradition for this kind

of biological risk assessment, one that extends at least to the

Clinton administration. In the late 1990s, for example, a clandestine

project run by the Defense Department re-created a genetically

modified, drug-resistant strain of the anthrax bacteria believed to

have been made by Soviet bioweaponeers. Such research helped the

government anticipate and prepare for emerging threats, according to

officials familiar with the anthrax study.

 

Some arms-control experts see the comparison as troubling. They

argued, then and now, that the work was a possible breach of a

U.S.-negotiated international law.

 

Legal and Other Pitfalls

The Bush administration argues that its biodefense research complies

with the Biological and Toxin Weapons Convention, the 1972 treaty

outlawing the manufacture of biological weapons, because U.S. motives

are pure.

 

" All the programs we do are defensive in nature, " said Maureen

McCarthy, Homeland Security's director of research and development,

who oversees NBACC. " Our job is to ensure that the civilian population

of the country is protected, and that we know what the threats are. "

 

Current and former administration officials say that compliance with

the treaty hinges on intent, and that making small amounts of

biowarfare pathogens for study is permitted under a broad

interpretation of the treaty. Some also argue that the need for a

strong biodefense in an age of genetic engineering trumps concerns

over what they see as legal hair-splitting.

 

" How can I go to the people of this country and say, 'I can't do this

important research because some arms-control advocate told me I

can't'? " asked Albright, the former Homeland Security assistant secretary.

 

But some experts in international law believe that certain experiments

envisioned for the lab could violate the treaty's ban on developing,

stockpiling, acquiring or retaining microbes " of types and in

quantities that have no justification " for peaceful purposes.

" The main problem with the 'defensive intent' test is that it does not

reflect what the treaty actually says, " said David Fidler, an Indiana

University School of Law professor and expert on the bioweapons

convention. The treaty, largely a U.S. creation, does not make a

distinction between defensive and offensive activities, Fidler said.

 

More practically, arms experts say, future U.S. governments may find

it harder to object if other countries test genetically engineered

pathogens and novel delivery systems, invoking the same need for

biodefense.

 

Already, they say, there is evidence abroad of what some are calling a

" global biodefense boom. " In the past five years, numerous

governments, including some in the developing world -- India, China

and Cuba among them -- have begun building high-security labs for

studying the most lethal bacteria and viruses.

 

" These labs have become a status symbol, a prestige item, " said Alan

Pearson, a biologist at the Center for Arms Control and

Non-Proliferation. " A big question is: Will these labs have transparency? "

 

Secrecy May Have a Price

When it opens in two years, the NBACC lab will house an impressive

collection of deadly germs and teams of scientists in full-body

" spacesuits " to work with them. It will also have large aerosol-test

chambers where animals will be exposed to deadly microbes. But the

lab's most controversial feature may be its secrecy.

 

Homeland Security officials disclosed plans to contractors and other

government agencies to classify the entire lab as a Sensitive

Compartmented Information Facility, or SCIF.

 

In common practice, a SCIF (pronounced " skiff " ) is a secure room where

highly sensitive information is stored and discussed. Access to SCIFs

is severely limited, and all of the activity and conversation inside

is presumed to be restricted from public disclosure. There are SCIFs

in the U.S. Capitol, where members of Congress are briefed on military

secrets. In U.S. nuclear labs, computers that store weapons data are

housed inside SCIFs.

 

Homeland Security officials plan to operate all 160,000 square feet of

NBACC as a SCIF. Because of the building's physical security features

-- intended to prevent the accidental release of dangerous pathogens

-- it was logical to operate it as a SCIF, McCarthy said.

 

" We need to protect information at a level that is appropriate, "

McCarthy added, saying she expects much of the lab's less-sensitive

work to be made public eventually.

 

But some biodefense experts, including some from past administrations,

viewed the decision as a mistake.

 

" To overlay NBACC with a default level of high secrecy seems like

overkill, " said Gerald L. Epstein, a former science adviser to the

White House's National Security Council and now a senior fellow with

the Center for Strategic and International Studies. While accepting

that some secrecy is needed, he said the NBACC plan " sends a message

that is not at all helpful. "

 

NBACC officials also have resisted calls for the kind of broad,

independent oversight that many experts say is necessary to assure

other countries and the American public about their research.

 

Homeland Security spokesmen insist that NBACC's work will be carefully

monitored, but on the department's terms.

 

" We have our own processes to scrutinize our research, and it includes

compliance to the bioweapons convention guidelines as well as

scientific oversight, " said Courtney, the NBACC scientific director.

 

In addition to the department's internal review boards, the agency

will bring in small groups of " three or four scientists " on an ad-hoc

basis to review certain kinds of potentially controversial

experiments, Courtney said. The review panels will be " independent, "

Courtney said, but he noted that only scientists with government

security clearances will be allowed to participate.

 

Some experts have called for unusual forms of oversight, including

panels of well-respected, internationally known scientists and

observers from overseas. While allowing that the results of some

experiments should be kept confidential, O'Toole, of the Center for

Biosecurity, argues that virtually everything else at NBACC should be

publicly accountable if the United States is to be a credible leader

in preventing the proliferation of bioweapons.

 

" We're going to have to lean over backward, " O'Toole said. " We have no

leverage among other nation-states if we say, 'We can do whatever we

want, but you can't. We want to see your biodefense program, but you

can't see ours.' "

 

In recent weeks, NBACC's first officially completed project has drawn

criticism, not because of its methods or procedures, but because heavy

classification has limited its usefulness.

 

The project was an ambitious attempt to assess and rank the threats

posed by dozens of different pathogens and delivery systems, drawing

on hundreds of studies and extensive computer modeling. When delivered

to the White House in January, it was the most extensive survey of its

kind, and one that could guide the federal government in making

decisions about biodefense spending.

 

Six months later, no one outside a small group of officials and

advisers with top security clearances has seen the results.

 

" Something this important shouldn't be secret, " said Thomas V.

Inglesby, an expert at the Center for Biosecurity who serves on a

government advisory board that was briefed on the results. " How can we

make policy decisions about matters of this scale if we're operating

in the dark? "

 

Tomorrow: A new era of engineered microbes.

& #65533; 2006 The Washington Post Company

http://www.washingtonpost.com/wp-dyn/content/article/2006/07/29/AR2006072900592_\

pf.html

 

 

 

Custom-Built Pathogens Raise Bioterror Fears

 

By Joby Warrick

Washington Post Staff Writer

Monday, July 31, 2006; A01

STONY BROOK, N.Y.

 

Eckard Wimmer knows of a shortcut terrorists could someday use to get

their hands on the lethal viruses that cause Ebola and smallpox. He

knows it exceptionally well, because he discovered it himself.

 

In 2002, the German-born molecular geneticist startled the scientific

world by creating the first live, fully artificial virus in the lab.

It was a variation of the bug that causes polio, yet different from

any virus known to nature. And Wimmer built it from scratch.

The virus was made wholly from nonliving parts, using equipment and

chemicals on hand in Wimmer's small laboratory at the State University

of New York here on Long Island. The most crucial part, the genetic

code, was picked up for free on the Internet. Hundreds of tiny bits of

viral DNA were purchased online, with final assembly in the lab.

 

Wimmer intended to sound a warning, to show that science had crossed a

threshold into an era in which genetically altered and

made-from-scratch germ weapons were feasible. But in the four years

since, other scientists have made advances faster than Wimmer imagined

possible. Government officials, and scientists such as Wimmer, are

only beginning to grasp the implications.

 

" The future, " he said, " has already come. "

 

Five years ago, deadly anthrax attacks forced Americans to confront

the suddenly real prospect of bioterrorism. Since then the Bush

administration has poured billions of dollars into building a

defensive wall of drugs, vaccines and special sensors that can detect

dangerous pathogens. But already, technology is hurtling past it.

While government scientists press their search for new drugs for old

foes such as classic anthrax, a revolution in biology has ushered in

an age of engineered microbes and novel ways to make them.

 

The new technology opens the door to new tools for defeating disease

and saving lives. But today, in hundreds of labs worldwide, it is also

possible to transform common intestinal microbes into killers. Or to

make deadly strains even more lethal. Or to resurrect bygone killers,

such the 1918 influenza. Or to manipulate a person's hormones by

switching genes on or off. Or to craft cheap, efficient delivery

systems that can infect large numbers of people.

 

" The biological weapons threat is multiplying and will do so

regardless of the countermeasures we try to take, " said Steven M.

Block, a Stanford University biophysicist and former president of the

Biophysical Society. " You can't stop it, any more than you can stop

the progress of mankind. You just have to hope that your collective

brainpower can muster more resources than your adversaries'. "

 

The Bush administration has acknowledged the evolving threat, and last

year it appointed a panel of scientists to begin a years-long study of

the problem. It also is building a large and controversial lab in

Frederick, where new bioterrorism threats can be studied and tested.

But overall, specific responses have been few and slow.

 

The U.S. Centers for Disease Control and Prevention has declined so

far to police the booming gene-synthesis industry, which churns out

made-to-order DNA to sell to scientists. Oversight of controversial

experiments remains voluntary and sporadic in many universities and

private labs in the United States, and occurs even more rarely overseas.

 

Bioterrorism experts say traditional biodefense approaches, such as

stockpiling antibiotics or locking up well-known strains such as the

smallpox virus, remain important. But they are not enough.

 

" There's a name for fixed defenses that can easily be outflanked: They

are called Maginot lines, " said Roger Brent, a California molecular

biologist and former biodefense adviser to the Defense Department,

referring to the elaborate but short-sighted network of border

fortifications built by France after World War I to prevent future

invasions by Germany.

 

" By themselves, " Brent said, " stockpiled defenses against specific

threats will be no more effective to the defense of the United States

than the Maginot line was to the defense of France in 1940. "

 

How to Make a Virus

Wimmer's artificial virus looks and behaves like its natural cousin --

but with a far reduced ability to maim or kill -- and could be used to

make a safer polio vaccine. But it was Wimmer's techniques, not his

aims, that sparked controversy when news of his achievement hit the

scientific journals.

 

As the creator of the world's first " de novo " virus -- a human virus,

at that -- Wimmer came under attack from other scientists who said his

experiment was a dangerous stunt. He was accused of giving ideas to

terrorists, or, even worse, of inviting a backlash that could result

in new laws restricting scientific freedom.

 

Wimmer counters that he didn't invent the technology that made his

experiment possible. He only drew attention to it.

 

" To most scientists and lay people, the reality that viruses could be

synthesized was surprising, if not shocking, " he said. " We consider it

imperative to inform society of this new reality, which bears

far-reaching consequences. "

 

One of the world's foremost experts on poliovirus, Wimmer has made de

novo poliovirus six times since his groundbreaking experiment four

years ago. Each time, the work is a little easier and faster.

 

New techniques developed by other scientists allow the creation of

synthetic viruses in mere days, not weeks or months. Hardware unveiled

last year by a Harvard genetics professor can churn out synthetic

genes by the thousands, for a few pennies each.

 

But Wimmer continues to use methods available to any modestly funded

university biology lab. He reckons that tens of thousands of

scientists worldwide already are capable of doing what he does.

 

" Our paper was the starting point of the revolution, " Wimmer said.

" But eventually the process will become so automated even technicians

can do it. "

 

Wimmer's method starts with the virus's genetic blueprint, a code of

instructions 7,441 characters long. Obtaining it is the easiest part:

The entire code for poliovirus, and those for scores of other

pathogens, is available for free on the Internet.

 

Armed with a printout of the code, Wimmer places an order with a U.S.

company that manufactures custom-made snippets of DNA, called

oglionucleotides. The DNA fragments arrive by mail in hundreds of tiny

vials, enough to cover a lab table in one of Wimmer's three small

research suites.

 

Using a kind of chemical epoxy, the scientist and his crew of graduate

assistants begin the tedious task of fusing small snippets of DNA into

larger fragments. Then they splice together the larger strands until

the entire sequence is complete.

 

The final step is almost magical. The finished but lifeless DNA,

placed in a broth of organic " juice " from mushed-up cells, begins

making proteins. Spontaneously, it assembles the trappings of a

working virus around itself.

 

While simple on paper, it is not a feat for amateurs, Wimmer said.

There are additional steps to making effective bioweapons besides

acquiring microbes. Like many scientists and a sizable number of

biodefense experts, Wimmer believes traditional terrorist groups such

as al-Qaeda will stick with easier methods, at least for now.

 

Yet al-Qaeda is known to have sought bioweapons and has recruited

experts, including microbiologists. And for any skilled microbiologist

trained in modern techniques, Wimmer acknowledged, synthetic viruses

are well within reach and getting easier.

 

" This, " he said, " is a wake-up call. "

 

From Parlor Trick to Bio-Bricks

The global biotech revolution underway is more than mere genetic

engineering. It is genetic engineering on hyperdrive. New scientific

disciplines such as synthetic biology, practiced not only in the

United States but also in new white-coat enclaves in China and Cuba,

seek not to tweak biological systems but to reinvent them.

 

The holy grail of synthetic biologists is the reduction of all life

processes into building blocks -- interchangeable bio-bricks that can

be reassembled into new forms. The technology envisions new species of

microbes built from the bottom up: " living machines from off-the-shelf

chemicals " to suit the needs of science, said Jonathan Tucker, a

bioweapons expert with the Washington-based Center for

Non-Proliferation Studies.

 

" It is possible to engineer living organisms the way people now

engineer electronic circuits, " Tucker said. In the future, he said,

these microbes could produce cheap drugs, detect toxic chemicals,

break down pollutants, repair defective genes, destroy cancer cells

and generate hydrogen for fuel.

 

In less than five years, synthetic biology has gone from a kind of

scientific parlor trick, useful for such things as creating

glow-in-the-dark fish, to a cutting-edge bioscience with enormous

commercial potential, said Choffnes, an expert on microbial

threats with the National Academies' Institute of Medicine. " Now the

technology can be even done at the lab bench in high school, " she said.

 

Along with synthetic biologists, a separate but equally ardent group

is pursuing DNA shuffling, a kind of directed evolution that imbues

microbes with new traits. Another faction seeks novel ways to deliver

chemicals and medicines, using ultra-fine aerosols that penetrate

deeply into the lungs or new forms of microencapsulated packaging that

control how drugs are released in the body.

 

Still another group is discovering ways to manipulate the essential

biological circuitry of humans, using chemicals or engineered microbes

to shut down defective genes or regulate the production of hormones

controlling such functions as metabolism and mood.

 

Some analysts have compared the flowering of biotechnology to the

start of the nuclear age in the past century, but there are important

differences. This time, the United States holds no monopoly over the

emerging science, as it did in the early years of nuclear power.

Racing to exploit each new discovery are dozens of countries, many of

them in the developing world.

 

There's no binding treaty or international watchdog to safeguard

against abuse. And the secrets of biology are available on the

Internet for free, said Robert L. Erwin at a recent Washington

symposium pondering the new technology. He is a geneticist and founder

of the California biotech firm Large Scale Biology Corp.

 

" It's too cheap, it's too fast, there are too many people who know too

much, " Erwin said, " and it's too late to stop it. "

 

A Darker Side

In May, when 300 synthetic biologists gathered in California for the

second national conference in the history of their new field, they

found protesters waiting.

 

" Scientists creating new life forms cannot be allowed to act as judge

and jury, " Sue Mayer, a veterinary cell biologist and director of

GeneWatch UK, said in a statement signed by 38 organizations.

 

Activists are not the only ones concerned about where new technology

could lead. Numerous studies by normally staid panels of scientists

and security experts have also warned about the consequences of abuse.

An unclassified CIA study in 2003 titled " The Darker Bioweapons

Future " warned of a potential for a " class of new, more virulent

biological agents engineered to attack " specific targets. " The effects

of some of these engineered biological agents could be worse than any

disease known to man, " the study said.

 

It is not just the potential for exotic diseases that is causing

concern. Harmless bacteria can be modified to carry genetic

instructions that, once inside the body, can alter basic functions,

such as immunity or hormone production, three biodefense experts with

the Defense Intelligence Agency said in an influential report titled

" Biotechnology: Impact on Biological Warfare and Biodefense. "

 

As far as is publicly known, no such weapons have ever been used,

although Soviet bioweapons scientists experimented with genetically

altered strains in the final years of the Cold War. Some experts doubt

terrorists would go to such trouble when ordinary germs can achieve

the same goals.

 

" The capability of terrorists to embark on this path in the near- to

mid-term is judged to be low, " Charles E. Allen, chief intelligence

officer for the Department of Homeland Security, said in testimony May

4 before a panel of the House Committee on Homeland Security. " Just

because the technology is available doesn't mean terrorists can or

will use it. "

 

A far more likely source, Allen said, is a " lone wolf " : a scientist or

biological hacker working alone or in a small group, driven by

ideology or perhaps personal demons. Many experts believe the anthrax

attacks of 2001 were the work of just such a loner.

" All it would take for advanced bioweapons development, " Allen said,

" is one skilled scientist and modest equipment -- an activity we are

unlikely to detect in advance. "

 

Genes for Sale

Throughout the Western world and even in developing countries such as

India and Iran, dozens of companies have entered the booming business

of commercial gene synthesis. Last fall, a British scientific journal,

New Scientist, decided to contact some of these DNA-by-mail companies

to show how easy it would be to obtain a potentially dangerous genetic

sequence -- for example, DNA for a bacterial gene that produces deadly

toxins.

 

Only five of the 12 firms that responded said they screened customers'

orders for DNA sequences that might pose a terrorism threat. Four

companies acknowledged doing no screening at all. Under current laws,

the companies are not required to screen.

In the United States, the federal " Select Agent " rule restricts access

to a few types of deadly bacteria, viruses and toxins. But, under the

CDC's interpretation of the rule, there are few such controls on

transfers of synthetic genes that can be turned into killers. Changes

are being contemplated, but for now the gap is one example of

technology's rapid advance leaving law and policy behind.

 

" It would be possible -- fully legal -- for a person to produce

full-length 1918 influenza virus or Ebola virus genomes, along with

kits containing detailed procedures and all other materials for

reconstitution, " said Richard H. Ebright, a biochemist and professor

at Rutgers University. " It is also possible to advertise and to sell

the product, in the United States or overseas. "

 

While scientists tend to be deeply skeptical of government intrusion

into their laboratories, many favor closer scrutiny over which kinds

of genetic coding are being sold and to whom. Even DNA companies

themselves are lobbying for better oversight.

Blue Heron Biotechnology, a major U.S. gene-synthesis company based in

suburban Seattle, formally petitioned the federal government three

years ago to expand the Select Agent rule to require companies to

screen DNA purchases. The company began voluntarily screening after

receiving suspicious requests from overseas, including one from a

Saudi customer asking for genes belonging to a virus that causes a

disease akin to smallpox.

 

" The request turned out to be legitimate, from a real scientist, but

it made us ask ourselves: How can we make sure that some crazy person

doesn't order something from us? " said John Mulligan, Blue Heron's

founder and chief executive. " I used to think that such a thing was

improbable, but then September 11 happened. "

 

Some scientists also favor greater scrutiny -- or at least peer review

-- of research that could lead to the accidental or deliberate release

of genetically modified organisms.

In theory, such oversight is provided by volunteer boards known as

institutional biosafety committees. Guidelines set by the National

Institutes of Health call on federally funded schools and private labs

to each appoint such a board. A 2004 National Academy of Sciences

report recommended that the committees take on a larger role in

policing research that could lead to more powerful biological weapons.

In reality, many of these boards appear to exist only on paper. In

2004, the nonprofit Sunshine Project surveyed 390 such committees,

asking for copies of minutes or notes from any meetings convened to

evaluate research projects. Only 15 institutions earned high marks for

showing full compliance with NIH guidelines, said Edward Hammond, who

directed the survey. Nearly 200 others who responded had poor or

missing records or none at all, he said. Some committees had never met.

 

Stockpiles Aren't Enough

New techniques that unlock the secrets of microbial life may someday

lead to the defeat of bioterrorism threats and cures for natural

diseases, too. But today, the search for new drugs of all kinds

remains agonizingly slow.

 

Five years after the Sept. 11 attacks, the federal government budgets

nearly $8 billion annually -- an 18-fold increase since 2001 -- for

the defense of civilians against biological attack. Billions have been

spent to develop and stockpile new drugs, most of them each tied to a

single, well-known bioterrorism threat, such as anthrax.

 

Despite efforts to streamline the system, developing one new drug

could still take up to a decade and cost hundreds of millions of

dollars. If successful, the drug is a solution for just one disease

threat out of a list that is rapidly expanding to include man-made

varieties.

 

In a biological attack, waiting even a few weeks for new drugs may be

disastrous, said Tara O'Toole, a physician and director of the Center

for Biosecurity at the University of Pittsburgh Medical Center.

 

" We haven't yet absorbed the magnitude of this threat to national

security, " said O'Toole, who worries that the national commitment to

biodefense is waning over time and the rise of natural threats such as

pandemic flu. " It is true that pandemic flu is important, and we're

not doing nearly enough, but I don't think pandemic flu could take

down the United States of America. A campaign of moderate biological

attacks could. "

& #65533; 2006 The Washington Post Company

http://www.washingtonpost.com/wp-dyn/content/article/2006/07/30/AR2006073000580_\

pf.html

 

 

" The care of the Earth is our most ancient and most worthy, and after

all our most pleasing responsibility. To cherish what remains of it

and to foster its renewal is our only hope. " Wendell Berry