Threat Assessment:  Experts Debate Restrictions for DNA Industry

The announcement last week that scientists had built a specimen of polio virus from scratch has led to concerns that the DNA synthesis industry should be better regulated to prevent proliferation of biological weapons, the Washington Post reported today (see GSN, July 12).

There are concerns that someone could discreetly purchase individual strands of made-to-order DNA, which are themselves harmless, and connect them to create a biological weapons agent, the Post reported.

“The customer gets to design the sequence they want manufactured and there is a limited ability for us to know what people are going to do with it,” said Roman Terrill, vice president of legal and regulatory affairs at Integrated DNA Technologies in Coralville, Iowa.

A scientist would need very little — about $10,000 and a few months — to develop the genetic components of a biological weapons agent, Terrill said. 

“You could buy your own used DNA synthesizer and make whatever you want in the comfort and privacy of your own garage,” he said.

There are about six U.S. companies that produce and sell small strands of DNA, called oligonucleotides or “oligos,” the Post reported.  While some scientists have said they are not in favor of new restrictions on oligo producers, which have become critical to the biotechnology industry, others have said that now might be the time to begin a public discussion on the issue.

U.S. restrictions prohibit shipment of pathogens classified as “select agents,” but those restrictions do not apply to shipments of DNA components within the United States, according to the Post.  The U.S. Commerce Department does require a license to ship DNA considered to be a potential threat oversees.  The department’s requirements, however, are vague and can easily be circumvented, scientists said.

Commerce’s restrictions on DNA shipments apply to strands “associated with pathogenicity,” which means the strands can lead to the ability to cause disease, Terrill said.

“The problem is the bureau has not released those sequences, so ... we would have to decide for ourselves whether a sequence is associated with pathogenicity,” he said.  “But how pathogenic?  And what does ‘associated’ mean?  The phrase is difficult to get a grasp on.  It’s not really a scientific term.  It’s a lawyer’s term.”

Any restrictions that are based on the pathogenicity of DNA strands, however, have little meaning now that scientists can take individual strands that are harmless and use them to create a biological agent, scientists said.

“I don’t know how you could overcome that problem,” said a Commerce official.  “You could get one part (of the sequence) from one company and another part from another company and completely circumvent the law.”

Some experts have suggested that there should be better oversight of the DNA synthesis industry, according to the Post. 

“We propose that ... those companies that produce the oligos should be asked to routinely check the sequences against those of known pathogens,” said Eckard Wimmer, who led the project to build the polio virus.

Other experts have suggested institutional review processes for scientists who plan to use DNA strands to develop viruses or other pathogens.

“I would argue there needs to be more oversight in terms of getting approval,” said Arthur Caplan, a University of Pennsylvania ethicist.  “Are we going to be seeing this kind of thing done in a science fair soon?  I’m in favor of tighter controls” (Rick Weiss, Washington Post, July 17).

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Smallpox:  Israel Should Produce Vaccine, Health Officials Say

The Israeli Health Ministry should immediately begin mass-producing the smallpox vaccine and consider acquiring the vaccine from commercial sources as well, several Israeli health officials wrote in this month’s Israel Medical Association Journal (see GSN, July 8).

It is “likely” that terrorists have already obtained smallpox and are prepared to use it in aerosol form against population centers, said the authors, Paul Slater of the Health Ministry’s Epidemiology Department, Emilia Anis of the Infectious Diseases Department and Alex Leventhal of Public Health Services (see GSN, Nov. 30, 2001).

Israel, which would need 9 million vaccine doses to inoculate the Israeli population and the Arab residents of the Palestinian territories, would probably not receive the vaccine from other countries in the near future and so should prepare itself now, they wrote (see GSN, April 25).  The Health Ministry’s Central Laboratories have produced the vaccine in the past.

“Vaccine production capability already exists, but it needs to be reactivated and expanded,” the authors wrote.

Israel would also need 65,000 milliliters of vaccinia immune globulin, which is used to treat complications caused by the vaccine, to cover the estimated number of Israelis and Palestinians who would probably develop complications, according to the authors.  Authorities should recruit 2,500 volunteers who were inoculated before the vaccination program ended in 1980 and revaccinate them to produce 65,000 milliliters of vaccinia immune globulin from their antibodies, the authors wrote.  To start revaccinating volunteers, officials should acquire a small amount of the globulin from the U.S. Centers for Disease Control and Prevention, the authors wrote.

Priorities:  Who Gets the Vaccine?

If a smallpox case occurs, Israel would need to establish priorities, the authors wrote.  Medical, laboratory, emergency, first-responder and burial personnel should receive the vaccine first.  The second priority would be anyone who had to face-to-face contact with a smallpox victim, followed by household members of those contacts.  Active duty soldiers would receive the vaccine next, followed by residents in the area where the case occurred and finally the entire population.

Personnel who would be involved in caring for smallpox patients, administering the vaccine and conducting interviews with the patients and contacts would have to receive the vaccine before beginning those tasks, the authors wrote.

“We must assume that in the event of a smallpox outbreak, no matter how small, vaccination of the entire Israeli population will need to be carried out,” the authors wrote.

Israeli authorities should also seriously consider resuming routine smallpox vaccination of the population “as improved vaccine becomes available,” according to the authors.

Isolating Patients

While initial smallpox cases would inevitably be taken to a hospital, “suspect smallpox cases must not intentionally be admitted to any open general medical facility” since they might infect other patients, the authors wrote.

Some smallpox victims could be cared for in military-style field hospitals or in a single hospital or isolated hospital wing, according to the authors.  An alternative for moderately ill patients would be to establish hospices, which should be prepared far in advance of an actual outbreak.  Eventually, if the number of patients surpassed the health system’s capacity for smallpox cases, the patients would have to be isolated at home.

Forcing a “large-scale quarantine” would be “undesirable” and probably unenforceable, the authors wrote.  When a smallpox case is first discovered, authorities should quickly set up vaccination centers in the area of the case to lessen public panic and encourage people in the area to remain at home to receive the vaccine.

Israel has the resources to overcome a smallpox attack, the authors wrote.

“A new smallpox outbreak in Israel must not be regarded as a doomsday event,” they wrote.  “If we make the necessary commitment now to vaccine production and stockpiling, laboratory preparation, planning, professional training and public education, the losses, although substantial, can be minimized” (Israel Medical Association Journal, July).

For further information, see:

CDC Smallpox Information

Journal of the American Medical Association Background on Smallpox

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U.S. Response I:  Washington to Serve as Biological Defense Model

Washington is scheduled to participate in a $420 million program designed to transform four U.S. cities into models for biological weapons defense, the Washington Post reported Sunday.

“There are lots of downsides to being the national capital,” said Margaret Kellems, deputy mayor for public safety and justice, who is in charge of biological weapons defense for Washington.  “The upside is that when you’re in the spotlight, you get the best treatment.  We think the District [of Columbia] is a bull’s eye.”

Under the new program, Washington will probably receive $85 million administered by the proposed homeland security department, according to the Post.  In the Bush administration’s fiscal 2003 budget proposal, officials included the program, called the National Bioweapons Defense Analysis Center, among Defense Department activities.  The program called for $120 million to build a bioterrorism research center and $300 million to create models in four major U.S. cities for future biological weapons defense systems, the Post reported.

Washington was chosen for the program because it is an obvious target for future biological weapons attacks and because it has already received many funds to improve public health preparedness, said Anna Johnson-Winegar, deputy assistant to the defense secretary for chemical and biological defense.  The second city chosen for the program is Albuquerque because it has a well-developed radiological accident response system, the Post reported.  The other two cities have yet to be chosen.

The purpose of the Pentagon program is to build a “system of systems,” Johnson-Winegar said.

“It would include biodetection, using information from medical surveillance systems and environmental sensors and integrating the data into one comprehensive system,” she said.

Under the program Washington will receive the best available “off-the-shelf” equipment, Johnson-Winegar said.  The other three cities will use more “experimental” technologies, she added.  Even though the Pentagon will probably not control the program, its goals will not change under a new administrator, Homeland Security Office spokesman Gordon Johndroe said.

Washington is also scheduled to receive funds to improve public health preparedness under a $1.1 billion Health and Human Services Department program, according to the Post (see GSN, June 7).  The city received $292 million in congressional funds to improve emergency preparedness in January.  In all, Washington could receive $400 million this year and in 2003 to improve defenses against a biological weapons, according to the Post.

Research Funding

Meanwhile, the proposed homeland security department is expected to take over $2 billion worth of biological weapons defense research projects from the National Institutes of Health, the Post reported.  The exact details of the program will probably remain vague until the Congress passes the White House’s fiscal 2003 budget and until the proposed homeland security department is created, according to the Post.

“We will provide the money and inform the scientists of the threat we want to examine,” Johndroe said.  “They do the research and disburse the money with their oversight.”

The Bush administration’s proposal to separate biological weapons defense research from the NIH might disrupt research efforts rather than improve them, several experts have said (see GSN, July 8).  Research efforts could further be damaged because the White House has not given control over Pentagon biological weapons defense research to the proposed department, according to experts.

“You really have to be careful not to disconnect some of these programs from where the expertise is,” said Peggy Hamburg, a vice president at the Nuclear Threat Initiative, a nonprofit organization that studies weapons of mass destruction.  “You can’t just carve out pieces of a department, label them ‘bioterrorism’ and expect to get the same results” (Guy Gugliotta, Washington Post, July 14).

[EDITOR’S NOTE: The Nuclear Threat Initiative is the sole sponsor of Global Security Newswire, which is published independently by National Journal Group, Inc.]

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U.S. Response II:  Homeland Security Should Not Include CDC, Ridge Says

U.S. Homeland Security Director Tom Ridge has said the Centers for Disease Control and Prevention should not join the proposed homeland security department, Bio-Terrorism.Info reported today (see related GSN story, today).

The CDC is expected to work with the proposed department to prevent future terrorist attacks using biological weapons, but the two should remain separate, Ridge said during testimony before two congressional committees last month.

“There is a dual infrastructure here,” Ridge said last month before the Senate Governmental Affairs Committee.  “That infrastructure should remain part of HHS [Health and Human Services Department].  The notion we would work through multiple agencies to establish protocol in advance of an incident is consistent with putting several agencies together, having a strategic focus.”

Senator Max Cleland (D-Ga.) tried to obtain assurances from Ridge that the CDC would be have jurisdiction over any future bioterrorism attacks, according to Bio-Terrorism.Info.  The CDC and the FBI came into conflict during last fall’s anthrax attacks because of conflicting rules, according to Cleland (see GSN, July 12).

“There may be a point at which someone concludes that a threat to public safety is occurring and therefore automatically, by a stroke of a pen, CDC becomes the lead agency,” he said.  “We don’t need competition.  We need coordination, cooperation and communication” (Bio-Terrorism.Info, July 15).

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