United States:  U.S. Technology Exported to Suspected Bioweapons States

By David Ruppe
Global Security Newswire

WASHINGTON — The U.S. Commerce Department in recent years licensed biotechnology exports to six countries that are not members of the 1972 Biological Weapons Convention and six suspected of having offensive biological weapons programs, according to a General Accounting Office report last month (see GSN, Oct. 2).

U.S. officials defended the approvals, saying they were made only after a thorough interagency review to ensure that the recipient governments would not divert the technology for illicit purposes, and that exports of controlled pathogens were in minute quantities intended for public health uses.

Between October 1999 and December 2001, Commerce licensed exports of dual-use pathogens or technology to Egypt, Israel, Kazakhstan, Trinidad and Tobago, Malawi and the United Arab Emirates, “none of which have ratified the BWC,” according to the GAO report.

In addition, Commerce cleared China, Cuba, India, Pakistan, Taiwan and Russia to receive exports even though they “are mentioned as possibly violating the BWC and carrying on offensive biological weapons research,” the report says.

U.S. officials have repeatedly criticized Cuba this year for exporting dual-use equipment to Iran and other so-called “rogue nations.”  Iran is a party to the convention but is suspected by the United States of producing biological weapons and supporting terrorism (see GSN, May 22).

“Cuba has provided dual-use biotechnology to other rogue states,” Undersecretary of State for Arms Control and International Security John Bolton said in a speech at the Heritage Foundation in May (see GSN, May 7).  “We are concerned that such technology could support BW programs in those states. We call on Cuba to cease all BW-applicable cooperation with rogue states and to fully comply with all of its obligations under the Biological Weapons Convention.”

Review Process Cited

A State Department official Thursday said the difference between the U.S. approvals and the Cuban exports is “very much apples and oranges.”

“The kinds of things we are going to be exporting are the kinds of things, even though they are classified as dual-use … that won’t contribute to a weapons program, that are going to contribute to legitimate purposes,” the official said.

Without speaking specifically to what was approved, the official said such things generally tend to include “gram quantities of a controlled pathogen” or “regular laboratory equipment.”

“I think the concern about people selling things to Iran is when they’re selling production technology or equipment to manufacture CW or BW.  They are the real significant things, they are not the gram quantities of a controlled substance or material,” the official said.

“So on the face of it, it might seem a little hypocritical, but it’s really not,” the official said.

The report, Arms Control:  Efforts to Strengthen the Biological Weapons Convention, was sent in late September to U.S. Representative Christopher Shays (R-Conn.), who chairs the National Security, Veterans Affairs and International Relations Subcommittee of the House Government Reform Committee, and released to the public late last month.

Reviewing the report before publication, Commerce expressed concern the report suggested it had acted “negligently.”

“The Department of Commerce is concerned that … the report could give the incorrect impression that the United States is negligently authorizing the export of pathogens that could be diverted to weapons of mass destruction (WMD) programs or other illicit uses,” wrote Deputy Assistant Secretary Matthew Borman.

He wrote it was “important to note” that such licenses to non-Biological Weapons Convention countries and certain countries of concern were authorized after “careful scrutiny” by Commerce, the State Department and the Pentagon, with intelligence community involvement.

The review, Borman wrote, was intended “to ensure the proposed end users are not involved in WMD programs and that the exports are not otherwise likely to be diverted.”

The items approved to nonsignatories were for human health purposes only, he wrote, such as “minute” quantities of aflatoxin for use to establish quality control standards to test food items for contamination.

The State Department official said if the department had a problem with any of the approvals they could have opposed them, bumping the decision up the chain to the president if need be.

“I don’t know of any case that have been escalated that high,” the official said.

“I imagine that a lot of these licenses have to do with gram quantities of a controlled pathogen or something that might be used in test kits, testing food, or water, or that kind of things,” the official said.  “So it’s very legitimate, benign uses, we see a lot of that kind of stuff, and then, regular laboratory equipment as well.”

The GAO report, however, contended that it is difficult to verify compliance with the treaty, because pathogens, knowledge and technology can have both commercial and military applications.

“Many pathogens that can be used to produce biological weapons also have commercial applications in the health and biotechnology spheres,” it says.

Difficult to Prove

The main focus of the report was to analyze various efforts to strengthen the Biological Weapons Convention.  The report says the absence of a strong verification mechanism is a factor making it difficult to prove suspicions of illicit programs.

The report says it is difficult to find proof by monitoring a country’s imports, because biological items that can be used for commercial research and production purposes also can be used for military purposes.

“The difference between developing a vaccine for humans and developing a biological weapon may be very small.  When developing a vaccine, a large volume of pathogen is created.  The development of the vaccine would require killing the pathogen.  But if the pathogen were to be used as a biological weapon, one would keep it alive,” it said.

The report says the BWC is weak because it lacks a strong verification mechanism.  The Bush administration last year rejected a draft protocol intended to create such a mechanism, saying it would be ineffective and could harm U.S. security interests and commercial interests. 

The GAO report says, though, “With no verification procedures, it is difficult to prove or disprove these allegations within the auspices of the BWC.”

U.S. officials have maintained that strengthening the BWC is not the solution for dealing with biological weapons proliferation and have proposed a list of other measures for international action.  They include criminalizing violations by individuals of prohibited activity and enhancing infectious disease surveillance and response.

U.S. officials are pushing for a quick resolution, without a protocol to the treaty, of the fifth annual BWC review conference scheduled to begin Monday in Geneva (see GSN, Nov. 7).

For further information, see:

BWC Text and Associated Documents (U.S. Defense Department)

BWC States Parties (U.S. State Department)

U.N. Background on BWC

Fifth Review Conference of BWC

Back to top

Smallpox:  Rumsfeld Recommends Smallpox Vaccine Plan For Military

U.S. Defense Secretary Donald Rumsfeld yesterday recommended a military smallpox immunization plan to President George W. Bush, but many of the president’s concerns were left unanswered, according to a White House official (see GSN, Oct. 15).

The plan would vaccinate up to 500,000 troops, beginning with emergency and medical personnel and moving on to U.S. forces in the Middle East that might see combat soon, the Washington Post reported.

“There’s a lot of issues on both sides,” the official said of Bush’s caution in making a decision on the vaccine.  “He’s concerned not just about whether to do it, but how you do it.  You don’t want to do it if you can’t do it right,” the official added (Allen/Graham, Washington Post, Nov. 8).

Back to top

Smallpox I:  Threat of Attack Deemed Low, U.S. Official Says

By David Ruppe
Global Security Newswire

WASHINGTON — Although a handful of states are suspected by U.S. authorities of illicitly possessing stores of smallpox virus, the probability of a smallpox attack against the United States is low, a senior U.S. official said yesterday (see GSN, Nov. 5).

“I think we’re looking at it at this point as a low risk of it being used as a weapon,” D.A. Henderson, the Health and Human Services Department’s top science adviser for public health preparedness, said.

He also said the information the United States has on suspected smallpox stores in other countries is “simply not terribly good.”

That view is relevant to the Bush administration’s pending decision on whether to vaccinate the entire U.S. population, about 290 million people, which Henderson said could cause an estimated 300 to 400 deaths and possibly 1,400 serious illnesses from the side effects of the vaccine. 

An alternative under consideration would be to vaccinate up to 500,000 medical and emergency response personnel (see GSN, Oct. 17).

Henderson’s view provides a counterpoint to a CIA assessment, reported by the Washington Post Tuesday, which concluded that Russia, France, North Korea and Iraq maintain undisclosed stocks of the virus.  The story also said al-Qaeda terrorists had sought the virus but had not successfully acquired it. 

Concerns about the perceived threat, the Post said, have strengthened the position of some in the administration pushing for vaccinating the U.S. population.  There are others, however, who support the more limited vaccination strategy, leaving President George W. Bush to make the decision, the story said.

Differing Degrees of Certainty

Following a successful campaign to eradicate smallpox amid a global outbreak in the 1960s and 1970s, the World Health Organization requested that all stores of the virus around the world be destroyed or turned over to the organization for storage at only two sites, one each in Russia and the United States.  By late 1983, all but those two countries had reported no longer possessing the virus.

Henderson has previously said he believes Iran and Iraq may have obtained samples when that outbreak passed through their respective countries.

In a briefing sponsored by the Chemical and Biological Arms Control Institute Tuesday, Henderson described as “probable” the possibility Russia was working on smallpox at one undeclared site.

“The Ministry of Defense production center, the principle center, at Sergiyev Posad, is still intact, it is a secret facility.  What all may be going on in there is very difficult to find out and frankly very little is known about that, except it is still wholly intact,” he said.

He listed as “possible” illicit stores at a number of other sites.

“We’ve had rumors from Russia of several other sites where smallpox virus might be present,” he said.

He said there were “varying degrees of certainty or uncertainty” regarding suspected stocks in North Korea, Iraq and Iran.

“The information we have as to where smallpox might be present, is simply not terribly good, and it is very hard to ascertain this,” he said

The CIA report also rated the levels of confidence in the intelligence on suspected stocks from high with respect to Russia, to not as high for Iraq and France, to medium for North Korea, according to the Post.

A French Foreign Ministry spokesman yesterday said the country does not have any smallpox stocks (see GSN, Nov. 6).

With respect to France, Henderson said, “I can’t verify or endorse what was said in the Washington Post.”

He suggested French stocks of smallpox vaccine might have served as a source of confusion, just as Swiss vaccine stocks recently were misinterpreted as the smallpox virus.

“Certainly, this allegation with regard to France.  I had no idea where that came from,” he said.

Henderson said the United Kingdom and the United States once also had trouble keeping track of their own stocks.  After making their declarations to the WHO, he said, “one of our military laboratories, one of our state health department laboratories, several places in Britain, discovered after they’d thought they’d destroyed it that they hadn’t destroyed it.”

“So they went ahead and autoclaved it and told us afterwards, ‘Oops, we didn’t realize that we had it,’” he said.

Back to top

Smallpox II:  In Case of Smallpox Attack, Immunize Everyone

By David McGlinchey
Global Security Newswire

All U.S. residents should probably be vaccinated if a terrorist attack spreads smallpox in the United States, the White House biological terrorism chief said yesterday, even though the vaccine might cause adverse affects in up to one-third of those immunized (see GSN, Oct. 18).

“There’s nothing else that one can really do at that point, other than make the vaccine available,” D.A. Henderson told Global Security Newswire.

Contracting the smallpox virus is much more dangerous and lethal than complications that arise from the vaccine, Henderson said.  Nevertheless, no U.S. officials are supporting mandatory immunization because the vaccine carries serious implications as well, he said.

“If we were vaccinating a hundred million people, [there would be] a fair number of deaths and a fair number of people with serious enough complications to wind up in the hospital,” Henderson said during a seminar hosted by the Chemical and Biological Arms Control Institute.  “There is no other vaccine which comes close to this in terms of severity of impact, and this is something that has to be recognized.  This is not influenza vaccine or polio vaccine,” he added.

Significant Medical Risks

In the midst of a debate on how to protect the United States from smallpox terrorism, health officials have noted that people with a variety of medical conditions are at high risk of adverse side effects.  Eczema, atopic dermatitis, pregnancy, and depressed immune systems are the primary ailments that increase the risk of adverse affects.  Officials do not agree on how many people fall into this category — estimates range as high as 30 percent of the U.S. population — but most say that the number is far higher than it was 30 years ago, when the United States last immunized against smallpox.

“There are significantly more people at risk for adverse reactions to the smallpox vaccine than there were three decades ago when the program ended,” said analyst David Evans, of the Washington-area ANSER research firm, in a written reply to questions.  “There is an increased number of people who are immune-suppressed.  This includes people with AIDS, hepatitis B and C [and an] increased number of individuals who have had organ transplants and may be taking immune suppressing drugs.”

Eczema is also a much more common ailment for people who live in the United States, and medical experts are not sure why, Henderson said.

Those with suppressed immune systems — particularly those infected with HIV — might be in the most danger.  Officials do not completely understand the effect of the vaccine on an HIV-positive person because HIV itself was not understood during the last wave of immunizations.  If the vaccine was found to result in certain death for those with HIV, health officials would need to find another solution to protect that population, Furmanski said.

Some analysts noted that the smallpox virus might also wreak havoc in other parts of the world.  There is no guarantee that a smallpox attack in the United States would respect international borders.  The factors that the United States faces in dealing with an immune-suppressed population become “significantly worse” if the virus surfaces in Africa, Evans said.

“An outbreak of wild smallpox would devastate an unprotected HIV-positive population.  One is appalled to think of what would happen in sub-Saharan Africa,” said independent researcher Martin Furmanski.

Weighing Consequences

Experts have generally agreed that in the face of a direct threat in the United States, the at-risk population would be better off taking their chances with the smallpox vaccine than with the virus.  Many of the vaccine’s side effects do not require hospitalization, Evans said.

“In the event of a confirmed smallpox outbreak … everyone who was actually exposed to smallpox should be vaccinated, without any exclusions because the extreme threat of wild smallpox presents a much greater danger than that of the vaccinia virus,” said Furmanski.

It is unclear, however, when it would become imperative to immunize everyone.

“Suppose we got an outbreak in Washington, D.C.?  What are you going to do in Minneapolis?  Are you going to recommend that everybody be vaccinated?” Henderson asked.

“At this stage, we probably would say no, unless we felt that there was some greater risk,” he said.

Planning for Contingencies

The U.S. Centers for Disease Control in Atlanta is trying to ensure that warnings to those at risk would spread quickly and effectively if the need were to arise, but several experts noted that it is difficult to form a single plan when there are many reasons a person might be at risk from the vaccine.

“It is a fairly random group in some sense,” Evans said.

The primary focus of the strategy is informing people who have not been immunized of what steps to take, according to Lisa Rotz, a medical epidemiologist in the CDC’s bioterrorism preparedness and response program.

“Right now we don’t have any other proven alternatives [to the vaccine],” Rotz said.

In the case of an outbreak or a heightened threat, health officials would probably try to reach at-risk people through local public health officials and media outlets, Rotz said.

“There are certain things you might not want to do, getting on public transportation and sitting next to someone you don’t know,” she said.  If a smallpox outbreak occurred, the disease would be spread by people who are unaware, she added, “someone who is coming down with symptoms but has had tickets to a sporting event for a while, and is going to go, no matter what.”

Scientists at the National Institute of Health are also developing a safer vaccine, continuing work that began years ago and was discontinued.

“Work was underway towards the end of the last inoculation.  It just so happened that they got rid of smallpox,” Rotz said.

Back to top

BWC:  Review Conference Could End Quickly

The chairman of the Fifth Review Conference of the Biological Weapons Convention — scheduled to begin next week in Geneva — plans to end the conference quickly without attempting to discuss a protocol to strengthen the treaty, a U.N. source said today (see GSN, Sept. 6).

Hungarian Ambassador Tibor Toth plans to introduce his proposal to end the conference quickly after it begins Monday, the U.N. source said.  Toth’s proposal also calls for a new review conference timetable, with shorter meetings to be held every year instead of every five years (Agence France-Presse, Nov.7).

The BWC Fifth Review Conference was originally scheduled to run from Nov. 11 to Nov. 22 (Xinhua.net, Nov. 11).

For further information, see:

BWC Text and Associated Documents (U.S. Defense Department)

BWC States Parties (U.S. State Department)

Fifth Review Conference of BWC

Back to top

Smallpox:  France Denies Smallpox Charge; Top U.S. Official Also Surprised

By David McGlinchey
Global Security Newswire

WASHINGTON — France officially denied today a newspaper report that it maintains stockpiles of smallpox virus, the Associated Press reported, and this morning a French strategic analyst and a top U.S. health official also said the allegations were surprising and questionable (see GSN, Nov. 5).

A classified CIA report labels France, North Korea, Iraq and Russia as countries that probably hold undisclosed stocks of smallpox, the Washington Post reported yesterday.

“France scrupulously respects its international engagements,” said French Foreign Ministry spokesman Bernard Valero.  “Therefore, France does not possess any stocks of smallpox in its laboratories, either civilian or military,” he said.

French researchers use only “authorized animal samples, which are not dangerous to man,” Valero said, refuting a U.S. official’s charge that France kept small amounts of the smallpox virus to research and defend against an outbreak.

In Washington, Jean-Francois Daguzan, a senior research fellow at the Foundation for Strategic Research in Paris said France has cooperated closely with the United States on defense issues, and claims of undisclosed smallpox stocks are “absolutely untrue.”

“I don’t know what happened with this paper, maybe there was confusion,” Daguzan said.  France “is a small country.  It is very controlled.  It is very strict,” he added.

France “abides strictly” to the Biological Weapons Convention and had, in fact, supported treaty verification protocols that the United States rejected, Daguzan said (see GSN, Oct. 1).

“This agency should concentrate on real threats and not this kind of allegation,” Daguzan said.

Leading Bush administration biological terrorism expert D.A. Henderson said that before yesterday he had not been aware of the allegations in the report, which supposedly had been circulated to top U.S. policy-makers.

It is not clear how the CIA reached its conclusion, Henderson said during a seminar hosted by the Chemical and Biological Arms Control Institute.  France declared in the 1970s that it had no smallpox, he said.

“This allegation regarding the French, I have no idea where that came from,” Henderson said of the report.  “I have no idea what the basis for this is.”

While Henderson said he is surprised by the claims, he added that it is unrealistic to absolutely ensure that every country has eliminated all stocks of smallpox.

“We saw no way in the world that we were going to verify — by going through all the deep freezers in the world — whether there was smallpox virus there,” he said.  “The only way one could determine this, was simply it had to be good faith.”

Back to top

Smallpox I:  United States Fingers Four Countries With Covert Stockpiles

U.S. intelligence officials believe that Russia, France, North Korea and Iraq maintain undisclosed stocks of smallpox virus, the Washington Post reported today.

Intelligence officials also have said that documents captured in the war on terrorism indicate that al-Qaeda terrorist leader Osama bin Laden has pursued smallpox and other biological weapons.  While U.S. intelligence has reportedly identified a “top five” list of agents that al-Qaeda has been seeking — including anthrax, ricin and botulinum toxin — an official said there is “no reason” to believe that bin Laden actually has acquired smallpox.

The CIA’s Weapons Intelligence, Nonproliferation and Arms Control Center revealed the smallpox assessments in briefings circulated among senior U.S. officials responsible for preventive measures.  According to reports circulated last spring, the CIA’s confidence level varies for the assessment for each country — Russia is the most certain to possess covert stocks — but one U.S. official said that the reports included only those countries for which “we have good evidence.”

Russia maintains one of the world’s two legal and acknowledged smallpox sites in Siberia, while the U.S. Centers for Disease Control and Prevention keeps the other legal stock in Atlanta (see GSN, Oct. 25).

The probability that Iraq and France maintain stockpiles of smallpox is “high,” officials said.  France’s stockpile is believed to be for defensive purposes, according to the Post.

There is a “medium” chance that North Korea has smallpox, according to the officials.

“The assessment is, they have it,” a U.S. official said of his own intelligence agency’s opinion of North Korea.  “We don’t say 70 percent certainty.  We assess that they have it.”

Others said, however, that in secretive countries it is difficult to know for sure.

“I have concluded on a very personal basis that there is a small chance that we will have definitive evidence, smoking gun evidence, for countries like North Korea, very closed societies,” an official said.

Some White House officials said that the recently revealed assessments alter the debate on whether, and how extensively, to inoculate the U.S. population.  An advisory panel to the U.S. Centers for Disease Control and Prevention recently recommended immunizing 500,000 first responders across the country (see GSN, Oct. 17).

“They give the scientific assessment of the what the risks of vaccination are,” a Bush administration official said of the CDC panel.  “They do not have the same amount of information” about the risk of a bioterrorist attack, the official said.

Reports of Iraq’s smallpox capability have alarmed its neighbors, according to the Post.  Kuwait’s U.S. ambassador Salem Abdullah Jaber Sabah said his country had requested smallpox vaccine last summer “in readiness for any eventuality.”

In light of the needs of the domestic population and political repercussions, the vaccine would probably not be provided to Iraq’s neighbors, according to U.S. officials.  Officials said that U.S. President George W. Bush could only promise assistance if an outbreak were to occur (Barton Gellman, Washington Post, Nov. 5).

Back to top

Smallpox II:  Children’s Tests Raise Ethical Concerns

Health officials and medical experts are debating the merits and risks of a proposed safety study on administering smallpox vaccine to children, the New York Times reported today (see GSN, Nov. 1).

“Everyone agrees that the risk of smallpox through a bioterrorism event is not zero,” said Karen Midthun, head of vaccine research for the U.S. Food and Drug Administration.  “But how small or large is that risk?  Given that it is so difficult to quantitate, it makes it difficult to know whether there is potentially any benefit to these children” (see related GSN story, today).

Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, proposed studying the risks, and the FDA is accepting public comment.

“If we had an attack and we had to use the vaccine in children, you would see a lot of eyebrow-raising if we didn’t know the effects,” Fauci said.

The vaccine itself can be fatal in very rare cases.  When it was last used in the 1970s, roughly 15 people of every million who were immunized suffered potentially life-threatening complications.  A 1968 study tracked 5.6 million immunized people, including 3.3 million children under the age of 4.  Of the children, 10 developed encephalitis — which causes brain inflammation — and three died.

Some experts do not even believe the health risk to children involved in the study is worth the potential benefit of completing the study.

“Smallpox doesn’t exist in this world, so the benefits are solely theoretical,” said Paul Offit, head of infectious diseases at the Philadelphia Children’s Hospital.  “That, in combination with the fact that the vaccine has known and, albeit rarely, severe side effects leads one to question whether you can ethically do that study.”

Neal Halsey, director of the Institute for Vaccine Safety at Johns Hopkins University, said he declined to take part in the tests even though he decided they were ethical if “done very carefully and done in a very limited number of children.”

“I do not care to be involved in exposing children to the known risks of the vaccine in the absence of a clear benefit,” Halsey said (Sheryl Gay Stolberg, New York Times, Nov. 5).

Back to top

Smallpox III:  Delays Expected for Acambis Vaccine

The British pharmaceutical company Acambis might miss a Dec. 31 deadline to provide 209 million doses of the smallpox vaccine to the United States, the Washington Post reported today (see related GSN story, today).

Both Acambis and the Bush administration have declined to confirm whether Acambis will be able to meet the end-of-year deadline that U.S. Health and Human Services Secretary Tommy Thompson set last year providing all the doses.  Information provided in a company presentation made in Toronto in June and in U.S. briefing documents several weeks ago suggests that company will only be able to finish part of the order on schedule, the Post reported (see GSN, Sept. 19).

The information also indicated, however, that the delays are not serious, according to the Post.  According to the information, Acambis was to have delivered 16 million vaccine doses by the end of last month, with 60 million due by the end of the year and 160 million due by the end of April.  The schedule for the remaining deliveries was unclear from the information, and Health and Human Services spokesman William Pierce said it is still in development.

“I think the fact they have come up with a vaccine as fast as they have — most of us look on this as some sort of a miracle,” said D.A. Henderson, White House bioterrorism adviser.  “There have been glitches in the whole thing, all sorts of them.  But they’re really pretty close on the mark of where they said they would be.”

Acambis is producing the vaccine in bulk in Austria, then purifying and packaging it at a company plant in Canton, Mass., the Post reported.  Chesapeake Biological Laboratories in Baltimore is providing final packaging for the vaccine doses and BioReliance Corp. in Rockville, Md., is providing final testing services.

Even though Acambis might not be able to provide its full order by Dec. 31, the urgency in building up the U.S. smallpox vaccine supply has eased somewhat since last year, according to the Post.  Studies have shown that an existing supply of 15 million doses could be diluted to provide up to 70 million doses, according to the Post (see GSN, March 29).  At a Philadelphia facility, the French pharmaceutical company Aventis SA has an additional 85 million doses that could also be diluted (see GSN, Oct. 10).

Acambis expects to be able to dilute its vaccine as well, which might mean that by the time the company fulfils its order, the United States would have as many as 1.5 billion doses available — enough for the entire United States and a large portion of the world, the Post reported (Justin Gillis, Washington Post, Nov. 5).

Back to top

U.S. Response:  U.S. Company Pays Fines for Illegal Exports

U.S. company Sigma-Aldrich Corp. has agreed to pay a $1.76 million fine to settle charges of illegally exporting biological toxins, the U.S. Commerce Department announced yesterday (see GSN, Nov. 4).  The fine is the largest ever imposed by the department in a case involving biological toxins.

Commerce had alleged that a company which Sigma-Aldrich acquired in 1997 had repeatedly exported controlled biological toxins illegally to Europe and Asia prior to the acquisition, and that it continued to do so for more than a year after the acquisition, according to a department press release.  Commerce does not believe that any of the exports were intended for use in biological weapons, according to the charges (U.S. Commerce Department release, Nov. 4).  The subsidiary has since obtained licenses for all subsequent exports of similar biological toxins, according to a Sigma-Aldrich release.

Prior to the settlement, Sigma-Aldrich faced 1,019 charges, with a maximum penalty of a fine of $10.78 million (Sigma-Aldrich release, July 23).  Commerce and Sigma-Aldrich agreed to a settlement based on 318 charges, including 268 of unlicensed exports of biological toxins, according to the Commerce press release.

The settlement followed a ruling by an administrative law judge that companies can be held responsible for export control violations committed by acquired firms.

“This settlement, and the administrative law judge ruling upon which it is based, make two things quite clear,” Undersecretary of Commerce for Industry and Security Kenneth Juster said in the press release.  “First, this Commerce Department will vigorously enforce our export control laws to prevent the spread of biological toxins and other substances that can be used for weapons purposes.  Second, corporations will be held accountable for violations of U.S. export control laws committed by companies that they acquire” (U.S. Commerce Department release).

Back to top

Smallpox:  U.S. Licenses Stockpiled Smallpox Vaccine

The U.S. Food and Drug Administration licensed a diluted version of the 30-year-old U.S. smallpox vaccine late last month, paving the way for broad immunizations.

“The license will allow the vaccine to be distributed and administered in a more efficient manner,” said John Modlin, a Dartmouth University professor who chairs the government advisory panel on immunizations.  

Administering an unlicensed vaccine is difficult process that requires monitoring, education and consent, according to Modlin.  “The only legal way to administer an unlicensed vaccine would be under Investigational New Drug regulations,” he said.

Defense personnel will probably receive the first 1.7 million doses of the vaccine, according to Jerome Hauer, biological defense chief at the Health and Human Services Department.  Emergency responders are in line to receive some of the remaining 13.7 million doses, which could also be used to respond to an attack (see GSN, Oct. 17).

The vaccine was licensed when it was produced in the 1970s but bifurcated needles and a liquid additive called a diluent required supplemental approval.  Food and Drug Administration officials made the licensing decision Oct. 25 but waited until Friday to announce it (Ceci Connolly, Washington Post, Nov. 2).

Back to top

Anthrax:  FBI Attempts to Recreate Spores Used in Attacks

U.S. investigators and scientists have been working for months to recreate the anthrax spores used in last year’s attacks, FBI Director Robert Mueller said Friday (see GSN, Oct. 29).

“We’re replicating the way or ways it might be manufactured, but it is not an easy task,” Mueller said.  “We are going into new territory in some areas.”

Personnel from several U.S. agencies are conducting the experiments at the Dugway Proving Ground in Utah, sources said (see GSN, May 21).  FBI officials refused to say whether investigators are using live anthrax bacteria in the research project and whether scientists are producing spores from scratch.

The FBI might be trying to determine how difficult it would have been to produce the spores used in last year’s attacks, according to some experts.

“They’d probably want to look at several methods of doing it — try to make it several different ways to reproduce the end result,” said David Franz, head of the Chemical and Biological Defense Division of the Southern Research Institute and former commander of the U.S. Army Medical Research Institute for Infectious Diseases at Fort Detrick, Md.  “It doesn’t seem like an unreasonable idea” (Eggen/Gugliotta, Washington Post, Nov. 2).

Simple Spores

Two scientists with knowledge of the FBI’s “Amerithrax” investigation believe it would have been relatively easy to manufacture the anthrax spores used in last fall’s attacks with only tabletop equipment costing a few thousand dollars, the Baltimore Sun reported yesterday (see GSN, Oct. 28).

While experts initially believed that the spores were treated with an additive such as silica to help them disperse more easily, many now believe that no additive was used and that the spores were made through a relatively simple process, the scientists said.

“There’s really nothing all that special about it,” one of the scientists said.  “There are many ways to do it.”

The confusion over the possible addition of silica could have occurred because X-ray studies of the spores used in the attacks detected evidence of the chemical element silicon, a component of silica, said Matthew Meselson, a Harvard University biologist.  Other studies have shown, however, that silicon exists naturally in anthrax, Meselson said.

The powder in the tainted letters was almost pure anthrax, with about 1 trillion spores per gram.  Such a high level of purity was believed to be another indication of the anthrax’s sophistication, according to the Baltimore Sun.

The purity level can be reached, however, through relatively simple production methods such as repeatedly processing the mixture in a centrifuge and removing nonspore materials, said one of the two scientists with knowledge of the FBI’s investigation.

While the anthrax produced in the former U.S. biological weapons program had a much lower purity level, that was because the methods used were meant for large-scale production, the scientist said.  The program could have produced a mixture with a higher purity level on a smaller scale, the scientist said (Scott Shane, Baltimore Sun, Nov. 3).

FBI Director Unsatisfied With Progress

Mueller also said Friday that he is not satisfied with the current status of the FBI’s inquiry into last year’s anthrax attacks, but investigators are making progress.

“Am I satisfied?  No, because we don’t have the person or persons responsible identified, and charges being brought against them,” Mueller said.  “Are we making progress?  Yes.  And we continue to make progress.  We continue to have a number of individuals that we are looking at” (Reuters/Los Angeles Times, Nov. 2).

For further information, see:

FBI Amerithrax Investigation

GSN Anthrax Attack Chronology (Dec. 12, 2001)

Back to top

U.S. Response:  States Need Better Plans for Biological Attack

Most U.S. states are not prepared to handle government medicine and vaccines stockpiled for potential biological weapons attacks, the Associated Press reported today (see GSN, Oct. 30).

The deadline for states to report their preparations for biological attack passed yesterday, but most do not have sufficient hospital beds, medical isolation areas or comprehensive plans to deal with vaccine stockpiles (see GSN, April 19).

“Our biggest concern is we will get to a location and a state or a city will not be ready,” said Jerome Hauer, assistant secretary for public health preparedness at the Department of Health and Humans Services.

States must have detailed plans for vaccinating their entire populations by Dec. 1, but that may prove difficult.  To date, only 20 of the 62 states, cities and territories receiving U.S. funding to prepare for a biological attack have submitted plans (see GSN, Sept. 23; Laura Meckler, Associated Press/Philadelphia Inquirer, Nov. 2).

Back to top

About Newswire  |  Contact National Journal  |  Re-Use Guidelines

HOME  |  CONTACT US  |  GET INVOLVED  |  SITE MAP