Global Security Newswire: By National Journal

    Issue for Monday, November 1, 2004

    Week in Review

    Search and View Past Issues

  terrorism  
U.S. Nuclear Plants Meet Deadline for Security Improvements, Industry Group Announces Full Story
Democratic Lawmakers Query Homeland Security Secretary on Chlorine Trains in Washington Full Story
U.S. Lawmakers Fail to Reach Compromise on Intelligence Reform Bill by November Elections Full Story
Recent Stories

  nuclear  
Iran Says EU Talks to Continue; Parliament Passes Uranium Enrichment Bill Full Story
Experts Say Brazil’s Resistance to Nuclear Inspections Raises Suspicions Full Story
IAEA to Conduct Inspections in South Korea This Week Full Story
Pentagon Says U.S. Troops Removed Materials From Iraqi Site; Not Clear If Missing Explosives Were Included Full Story
ElBaradei to Press Ahead for Third Term Full Story
Sweden Denies Asylum to Israeli Whistleblower Full Story
Recent Stories

  biological  
Biodefense Vaccine Regulations Should be Further Relaxed, Official Says Full Story
Recent Stories

  chemical  
Iraqi Insurgents Threaten Chemical Attacks Against U.S. Forces Full Story
Russia Set to Destroy 20 Percent of Chemical Arsenal by 2007, Official Says Full Story
Recent Stories

 

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Their stated reason, the idea that the IAEA can’t be trusted, is incredibly insulting and downright loopy.
Henry Sokolski executive director of the Nonproliferation Policy Education Center, on Brazil’s resistance to completely transparent inspections at its Resende uranium enrichment facility.


Iranian students demonstrated today in support of Iran’s plans to resume uranium enrichment (AFP photo/Atta Kenare).
Iranian students demonstrated today in support of Iran’s plans to resume uranium enrichment (AFP photo/Atta Kenare).
Iran Says EU Talks to Continue; Parliament Passes Uranium Enrichment Bill

Iranian Foreign Minister Kamal Kharazi yesterday welcomed passage of legislation in his country’s parliament to resume uranium enrichment, Agence France-Presse reported (see GSN, Oct. 29)...Full Story

U.S. Nuclear Plants Meet Deadline for Security Improvements, Industry Group Announces

By Mike Nartker, Global Security Newswire

WASHINGTON — The main trade organization for the U.S. nuclear industry announced Friday that all 103 U.S. nuclear power plants have implemented increased security measures in response to changes made by the Nuclear Regulatory Commission as to the type of terrorist threat plants must be able to defend against (see GSN, Sept. 15)...Full Story

Democratic Lawmakers Query Homeland Security Secretary on Chlorine Trains in Washington

By Joe Fiorill, Global Security Newswire

WASHINGTON — Rail operator CSX has for seven months been voluntarily rerouting shipments of chlorine and other toxic materials to avoid the U.S. capital, but the Homeland Security Department appears never to have considered requiring the company to make the measure permanent, House of Representatives Democrats said today (see GSN, Oct. 26)...Full Story

Current Issue Monday, November 1, 2004
terrorism

U.S. Nuclear Plants Meet Deadline for Security Improvements, Industry Group Announces

By Mike Nartker, Global Security Newswire

WASHINGTON — The main trade organization for the U.S. nuclear industry announced Friday that all 103 U.S. nuclear power plants have implemented increased security measures in response to changes made by the Nuclear Regulatory Commission as to the type of terrorist threat plants must be able to defend against (see GSN, Sept. 15).

There are concerns, though, regarding the commission’s ability to review the new security plans in place at U.S. nuclear plants and regarding plans by the nuclear industry to use private contractors to conduct mock attacks to evaluate security efforts.

In April 2003, the NRC ordered that all U.S. nuclear plants have in place by Oct. 29, 2004 new security plans to reflect changes made by the commission to the Design Basis Threat — the size and type of a potential terrorist force nuclear plants must be able to defend against. While details of the new DBT are classified, NRC spokesman Dave McIntyre said today that the threat was revised to reflect the new security threat following the Sept. 11, 2001, terrorist attacks.

Over the past 18 months, U.S. nuclear plants have implemented a number of new security measures, according to the Nuclear Energy Institute, such as increased guard forces and training, “substantial” physical improvements to defend against car bombs and the creation of a “rigorous” mock attack regime to evaluate security plans. Since 2001, the U.S. nuclear industry has spent more than $1 billion on efforts to improve security, the institute said in a press release.

“These security enhancements will continue to make nuclear power plants the most secure industrial facilities in America,” NEI Chief Nuclear Office Marvin Fertel said in a statement.

In September, however, the U.S. Government Accountability Office raised concerns over the NRC’s ability to adequately evaluate the new security plans in place at nuclear power plants. In testimony before a House Government Reform subcommittee, senior GAO official Jim Wells described the commission’s efforts to evaluate new plant security plans as largely a “paper review” that was not detailed enough to adequately determine whether the plans could defend against the new design basis threat. For example, Wells told lawmakers that GAO officials found that plant security plans were often based on a template and lacked site-specific information. 

McIntyre today, though, dismissed the GAO’s criticisms of the commission’s security review efforts, saying they were “way off the mark.”

“It’s a hand’s on, day-in, day-out inspection process,” he said. 

Concerns have also been raised over the NRC’s plans to rely on mock attack exercises to evaluate the new security plans, with the GAO saying in September that it will take three years for such exercises to be conducted at all plants. NEI also came under fire this summer for its decision to hire the Wackenhut Corp. security company to train and manage two permanent adversarial teams that would be used in the mock attack exercises because the company also provides security personnel for about half of U.S. nuclear plants.

Both the NRC and NEI have defended plans to use Wackenhut personnel in the mock attack exercises, noting the experience the company has in providing nuclear plant security and the strict scrutiny to which the exercises will be subjected.

In its statement Friday, NEI called for increased focus to be placed on efforts to integrate police and emergency responders with nuclear plant security forces. To help such efforts, a Nuclear Sector Government Coordinating Council, consisting of industry and government officials, has been created and held its first meeting earlier this month, NEI said.


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Democratic Lawmakers Query Homeland Security Secretary on Chlorine Trains in Washington

By Joe Fiorill, Global Security Newswire

WASHINGTON — Rail operator CSX has for seven months been voluntarily rerouting shipments of chlorine and other toxic materials to avoid the U.S. capital, but the Homeland Security Department appears never to have considered requiring the company to make the measure permanent, House of Representatives Democrats said today (see GSN, Oct. 26).

Activists had complained of ambiguity about whether CSX had resumed shipping the materials through the city following a temporary suspension enacted after the March 11 train attack in Madrid.

In a letter sent Friday to Homeland Security Secretary Tom Ridge, three Democratic members of the House Select Committee on Homeland Security said “numerous unclassified meetings and telephone conversations conducted by our staff” indicated that CSX has been voluntarily rerouting the shipments for seven months and that Homeland Security has no plans to make such a step mandatory or permanent.

“It may be Halloween,” Representative Edward Markey (D-Mass.) said in a statement released with the letter, “but that is no excuse for neglecting one of the most straightforward methods of removing the most catastrophic consequences of a terrorist attack on shipments of highly toxic materials. Even the railroad itself has evidently concluded these shipments are too dangerous to send through our nation’s capital.”

District of Columbia Council Judiciary Committee Chairwoman Kathy Patterson said in an interview today that she has “no corroboration” of the three representatives’ information about voluntary rerouting by CSX. “It would be good to have that corroborated,” Patterson said, and “it would be good for it to be permanent.”

CSX, Select Committee on Homeland Security Republicans and the Homeland Security Department did not respond to requests for comment.

The CSX trains pass through the heart of Washington, and some estimates indicate a chlorine cloud from a ruptured tanker could endanger thousands of lives within minutes (see GSN, Oct. 20).

Homeland Security is set this month to release a long-awaited security plan for the shipments, which environmental and consumer groups and local politicians say terrorists could use as chemical weapons by attacking one of the rail tankers.

Ridge said Saturday that the department “will work with” cities to reroute some hazardous-materials rail shipments in response to the latest videotaped threats from al-Qaeda leader Osama bin Laden. Patterson and fellow council member Phil Mendelson wrote Ridge today to thank him for acknowledging the danger posed by the shipments and to call for mandatory steps to protect Washington.

“Please understand that in the absence of federal action to address the constant danger posed by hazardous cargo shipments through Washington, D.C., local officials must and will take action,” the council members wrote. Mayor Anthony Williams said at a hearing last week of the council’s Judiciary Committee that he could be persuaded to sign new legislation on the matter.

The local legislators and members of Congress such as Markey have championed permanent rerouting, while the rail industry and some officials in President George W. Bush’s administration have cited economic drawbacks of rerouting and the possibility that the move would shift the risk of terrorism to other locations.

The three House members wrote Ridge to present the results of their investigation into the matter and to seek an explanation of the department’s approach.

“When your staff was questioned on Oct. 14, 2004, regarding its analysis of the economic and other considerations associated with rerouting, they were unable to provide a response and had no idea whether such an analysis had been conducted by anyone at the department,” wrote Markey, top committee Democrat Jim Turner (Texas) and Delegate Eleanor Holmes Norton (D-D.C.).

“This left the impression that, rather than conducting a true vulnerability assessment that considered all possible security solutions, the department instead directed the staff to consider all options except rerouting as it developed its security plan,” they wrote.

The lawmakers expressed support for using “increased patrols and new technologies” to protect the shipments but added that “it is simply not possible to secure every mile of track around Washington, D.C. (as well as numerous other cities nationwide), from attack.”

“A rigorous analysis may show that rerouting is not always the complete solution. However, as a result of the department’s failure to perform this analysis, neither Congress nor the administration will have sufficient information with which to consider its benefits or limitations,” the Democrats wrote.

The legislators called on Ridge to explain why Homeland Security did not consider rerouting, make available for questioning the department officials involved and provide information about the department’s decision-making process regarding the shipments, about the costs and schedule of the security plan expected this month and about planned vulnerability assessments of railroads around other major U.S. cities.

Greenpeace Toxics Campaign Legislative Director Rick Hind said today that, although CSX now appears to have been rerouting the shipments around Washington since the Madrid attack, the company has cultivated “purposeful ambiguity” about the measures it was taking.

Hind said in an interview that not making rerouting mandatory leaves open the possibility that the trains will again be routed through Washington once the electoral season concludes with the presidential inauguration in January. If the trains are not permanently rerouted to avoid Washington, he said, CSX and Homeland Security will have to rely on threat intelligence to decide whether and when to circumvent the city.

“Intelligence is so discredited that rerouting for D.C. and other important areas is what is called for. The secrecy behind this is pandering to the industry and is not in the national security interests of D.C. or the country,” Hind said.

Hind blasted Ridge for announcing measures that were already being undertaken “in secret.”

“The fact that rerouting had been going on in secret for seven months is even more newsworthy because it catches him playing politics and misleading the public by falsely implementing safeguards that were already implemented,” Hind said.

“It’s like requiring the sun to rise in the east,” he said.


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U.S. Lawmakers Fail to Reach Compromise on Intelligence Reform Bill by November Elections

By Mike Nartker

Global Security Newswire

WASHINGTON — U.S. lawmakers said Friday that they were disappointed about the lack of progress made to date in reaching a compromise intelligence reform bill, but added that they believed a bill could be ready for final approval when Congress reconvenes later this month for a “lame-duck” session (see GSN, Oct. 27).

Over the past two weeks, House and Senate negotiators have sought to work out the differences in their separate intelligence reform bills, which seek to restructure the U.S. intelligence community through the creation of a national intelligence director and a national counterterrorism center as proposed by the Sept. 11 commission. Lawmakers had previously expressed hope that an intelligence reform bill could be completed and signed by President George W. Bush by the tomorrow’s elections.

“It is very disappointing that we have been unable to negotiate an agreement to date. But I am heartened by the determination of each of us to keep negotiating towards the goal of reaching an agreement,” Senate Governmental Affairs Committee Chairwoman Susan Collins (R-Maine) said in a conference call with reporters.

House Permanent Select Committee on Intelligence Chairman Pete Hoekstra (R-Mich.) described the differences between the two intelligence reform bills as “complex” and “difficult.”

“We’re realistic about the work — significant work needs to be done. Compromise needs to be made.  But with all of us working, we believe that it is possible — it will be difficult, but it is possible that a bill can be completed,” he said.

One of the main sticking points so far in resolving the differences between the House and Senate bills centers on how much of a role the defense secretary should have in allocating funds to various intelligence agencies. The Senate has proposed that intelligence funds should be under the “direct jurisdiction” of the new national intelligence director, who in turn would allocate them directly to the various intelligence agencies. The House of Representatives, however, has proposed that the national intelligence director should allocate intelligence funds through the heads of various departments, including the defense secretary, rather than directly to the intelligence agencies.

“The initial hurdle we’re facing is the one that intelligence reformers faced for the last half century, which is: Can you have genuine intelligence reform and now a strong national intelligence director, and allow the Department of Defense to maintain some form of budget authority over the intelligence budget?” said Senator Joseph Lieberman (Conn.), the top Democrat on the Senate Governmental Affairs Committee.

Last week, Chairman of the Joint Chiefs of Staff Gen. Richard Myers sent a letter to House Armed Services Committee Chairman Duncan Hunter calling for the defense secretary to continue to have a role in the allocation of intelligence funds in any compromise intelligence reform bill. 

Such a “critical provision,” Myers wrote, “would allow the combat support agencies to continue their outstanding support to the warfighters, our ongoing counterterrorism efforts and the men and women of our nation’s armed forces serving in harm’s way.”

In addition, former Sept. 11 commission staff director Philip Zelikow said in a message sent to Senate staff members last week that differences over a “pass-through” arrangement for intelligence funds “should not be a reason for bringing down the whole bill.”

Both the Sept. 11 commission and the White House earlier this month, though, came out in favor of the budget authorities for the new national intelligence director as envisioned in the Senate bill.

The House and Senate also differ as to whether the overall total of the intelligence budget should be declassified, with the Senate and the Sept. 11 commission supporting the move and the House and the White House opposed. In addition, the two bills also continue to differ on several aspects of the planned national counterterrorism center.

Late Friday, House negotiators submitted a second proposal to resolve the differences between the two intelligence reform bills, which included support for the Senate-backed provisions to have the director of the national counterterrorism center be confirmed by the Senate and to have the director report to the president on joint counterterrorism operations. The proposal does not indicate a shift, though, on the stance of House negotiators regarding how intelligence funds should be allocated or whether the total intelligence budget is to be declassified. 

Senate negotiators are expected to respond to the House proposal early this week, according to Hoekstra.

Lieberman said Friday that if lawmakers were unable to complete an intelligence reform bill by the end of the lame-duck session, it would represent a “shameful failure” for Congress.

“We are very accustomed to using a phrase in Congress — ‘Don’t let the perfect be the enemy of the good.’   In this case, the quest for the perfect may well be the enemy of the safety and security of the American people, and therefore we have to commit ourselves to a quest for the good, for the best we can do before the lame-duck session to improve our security,” he said.


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nuclear

Iran Says EU Talks to Continue; Parliament Passes Uranium Enrichment Bill


Iranian Foreign Minister Kamal Kharazi yesterday welcomed passage of legislation in his country’s parliament to resume uranium enrichment, Agence France-Presse reported (see GSN, Oct. 29).

“This is a decision that testifies to Iranian honor. Iran must not be deprived of this legal and legitimate right,” Kharazi said (Agence France-Presse/SpaceWar.com, Oct. 31).

The conservative-dominated parliament overwhelmingly passed the enrichment measure, with calls of “Death to America” by some lawmakers. The vote yesterday was largely symbolic, according to AFP, and comes ahead of another round of nuclear talks scheduled Friday in Paris with France, Germany and the United Kingdom.

“We are expecting from [them] a calendar of cooperation and we will insist on that point,” Foreign Ministry spokesman Hamid Reza Asefi told reporters.

“We expect that in the course of this (Paris) meeting the Europeans will specify their precise commitments, concrete and clear, and the Islamic Republic will take the best decision in line with its own interests,” he added.

“Certain progress” was made at last week’s meeting with the European powers in Vienna, according to Asefi, as compared with the week earlier, when he had described the European proposals as “unbalanced.”

“Offering Iran a supply of fuel is a positive step, which we welcome, but this must not deprive Iran of its right to nuclear technology for peaceful reasons,” he said.

He urged the Europeans to “clarify what they mean,” adding that Iran could agree to a suspension of uranium enrichment that would last until a long term solution is found (Agence France-Presse/SpaceWar.com, Oct. 31).

Meanwhile, Pope John Paul II told Iran’s new ambassador to the Vatican that the “conditions and mechanisms of control” of multinational agreements, including those on “the commerce of weapons and the nonproliferation of nuclear weapons” are necessary in moving toward a more peaceful world, Reuters reported.

Although his address to Ambassador Mohamed Javad Faridzadeh was couched in general terms, according to Reuters, the Pope’s comments had clear implications for the standoff over Iran’s nuclear program (Philip Pullella, Reuters, Oct. 29).


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Experts Say Brazil’s Resistance to Nuclear Inspections Raises Suspicions


Brazil’s resistance to nuclear inspections since it began observing the Nuclear Nonproliferation Treaty in 1997 has raised concern among experts that the country could export nuclear technology, allowing it to get into the hands of rogue states or terrorists, the New York Times reported Saturday (see GSN, Oct. 25).

Experts have said they worry about Brazil’s export controls, according to the Times, citing as an example its clandestine shipments of uranium and technical assistance to Iraq in the 1980s.

They have also said that the secrecy surrounding the Resende uranium enrichment facility outside Rio de Janeiro has increased suspicions about Brazil’s intentions.

“I don’t see how this should be one of their major preoccupations,” said James Goodby, former U.S. chief negotiator on nuclear proliferation issues during the Clinton administration. “Don’t they at least worry what the rest of Latin America, especially the Argentines, think of this?”

Brazil has always aspired to be taken seriously as a world power, however, so the government’s boldness and the nuclear program itself have been popular in Brazil, according to the Times.  Past sleights by world leaders, such as former U.S. President Ronald Reagan’s confusing of Brazil and Bolivia and former French President Charles de Gaulle’s dismissing the nation of some 180 million people as “not a serious country” have only add fuel to Brazil’s nuclear ambition, the Times reported.

Resistance to comprehensive international inspections may also be linked to the belief of some in Brazil that an international conspiracy exists to keep Brazil from becoming a great power. Some Brazilian officials have argued that the International Atomic Energy Agency itself has conspired to deny Brazil the right to develop a valuable technology, according to the Times.

“Why are the Brazilians hiding both the casing and the rotors of their centrifuges?” said Henry Sokolski, executive director of the Nonproliferation Policy Education Center. “Their stated reason, the idea that the IAEA can’t be trusted, is incredibly insulting and downright loopy.”

Doubts have also been raised about how innovative the centrifuge process Brazil seeks to protect really is.

“These claims of a need to protect industrial secrets are exaggerated, since this technology is used routinely in other applications in other parts of the world,” said Jose Goldemberg, Brazil’s minister of science and technology in the early 1990s who forced an end to the military’s secret nuclear program at the time. “National pride is involved here, but I don’t know if that is worth arousing the suspicion of the rest of the world.” (Larry Rohter, New York Times, Oct. 31).


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IAEA to Conduct Inspections in South Korea This Week


The International Atomic Energy Agency is set to conduct a third round of inspections this week in South Korea as part of its investigation into Seoul’s past nuclear experiments involving plutonium and enriched uranium, officials said yesterday (see GSN, Oct. 29).

An IAEA team is set to arrive in South Korea tomorrow for a six-day visit, said Science and Technology Ministry officials. The purpose of the visit is to “double-check the results of the previous rounds of investigations and finalize a report to be presented to an IAEA board meeting,” a ministry official said (Agence France-Presse/SpaceWar.com, Oct. 31).


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Pentagon Says U.S. Troops Removed Materials From Iraqi Site; Not Clear If Missing Explosives Were Included


The U.S. Defense Department announced Friday that U.S. forces removed about 250 tons of material from the Iraqi al-Qaqaa facility in April 2003, but did not say whether the removed material included any of the almost 380 tons of explosives under International Atomic Energy Agency seal reported missing from the site, according to the Washington Post (see GSN, Oct. 29).

During the April 2003 operations, U.S. forces removed materials such as “plastic explosives,” TNT and detonation cords from storage bunkers at the site, said Army Maj. Austin Pearson. He also said, though, that he did not see any closed bunkers or seals placed by the IAEA on bunkers containing HMX explosives, one of the types of reportedly missing explosives capable of being used to detonate a nuclear weapon, the Post reported.

“I did not see any IAEA seals at the locations that we went into,” Pearson said. “I was not looking for that.  My mission specifically was to go in there and to prevent the exposure of U.S. forces and to minimize that by taking out what was easily accessible” (Graham/Lynch, Washington Post, Oct. 30).

Meanwhile, French journalist Sara Daniel has said that she saw looting at the al-Qaqaa facility when she visited the site in November of last year, according to the International Herald Tribune.

In a piece set to be published Wednesday in the French weekly Le Nouvel Observateur, she described insurgents having easy access to weapons at the site, the Herald Tribune reported. Daniel could not confirm, though, seeing HMX explosives or bunkers sealed by the IAEA.

“I was utterly stupefied to see that a place like that was pretty much unguarded and that insurgents could help themselves for months on end,” Daniel said. “We were there for a long time and no one disturbed the group while they were loading their truck” (Katrin Bennhold, International Herald Tribune, Oct. 30-31).

The Boston Globe reported Saturday that U.N. weapons inspectors sought permission to return to Iraq in the aftermath of the war to help monitor weapons sites, including al-Qaqaa, but were denied.

“They wanted to go. They were begging to go,” said David Albright, head of the Institute for Science and International Security and a former U.N. inspector. “They would have gone to al-Qaqaa and said, ‘Here’s the HMX. Burn it.’  They would have been a driver of efforts to find these things. … They would have provided a tremendous service.”

The inspectors request to return to Iraq was denied, a U.S. official said, because of logistical and timing issues, as well as the fact that the coalition was conducting inspection-related activities.

“The U.S. and U.K. were taking the lead in searching for the arms, and there was really no reason” for U.N. inspectors to return, U.S. mission to the United Nations spokesman Joe Merante said (Stockman/Bender, Boston Globe, Oct. 30).


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ElBaradei to Press Ahead for Third Term


International Atomic Energy Agency Director General Mohamed ElBaradei is unlikely to renounce his plans for a third term in the post despite increased U.S. opposition following agency revelations of missing explosives in Iraq just days before the U.S. presidential elections, Reuters reported (see GSN, Oct. 25).

A senior U.S. official said Friday the Bush administration would seek to unseat ElBaradei if Bush is re-elected on Nov. 2. The official accused ElBaradei of interfering in the election by reporting that 377 tons of explosives were missing from an Iraqi site which the U.S. military did not secure in the aftermath of its invasion.

A diplomat close to the IAEA, however, said ElBaradei “enjoys huge support from the majority of member countries of the IAEA.”

“As far as I know, he would not be swayed by any new opposition to his candidature coming from Washington,” the diplomat added.

An IAEA spokeswoman declined to comment, according to Reuters (Marcus Kabel, Reuters, Oct. 30).


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Sweden Denies Asylum to Israeli Whistleblower


Sweden Friday denied asylum to Mordechai Vanunu, who was released from an Israeli prison in April after serving an 18-year term for revealing Israel’s nuclear program, Agence France-Presse reported (see GSN, July 26).

“Mordechai Vanunu had applied for asylum in Sweden and I think in several other countries. ... We have rejected his application,” Mats Baurmann of the Swedish Migration Board told AFP.

Vanunu is not living in Sweden and thus cannot be considered a refugee, according to Baurmann.

“We haven’t tried his case at all, because he is not considered a refugee. Had he been in Sweden, we would have been required by law to try his case, and even if he had been living in a third country we may have taken him in on a special refugee quota,” he added.

Vanunu has said he wants to leave Israel where he is widely reviled as a traitor for revealing the Israeli nuclear program and for converting to Christianity, according to AFP.

“The only way to feel and enjoy freedom and start my new life as a free human being will be when I can leave Israel and live my life in the U.S., in Europe or in London,” he told the BBC last week (Agence France-Presse/SpaceWar.com, Oct. 29).


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biological

Biodefense Vaccine Regulations Should be Further Relaxed, Official Says

By David Ruppe
Global Security Newswire

WASHINGTON — U.S. regulations on testing new biological defense drugs and vaccines should be relaxed in the future, a senior Defense Department official suggested Friday. The official argued that current rules requiring primate testing take too long to approve a vaccine.

Charles Gallaway, director of the chemical and biological defense directorate of the Defense Threat Reduction Agency, said changes eventually should be considered that might allow for testing “at the cellular level” or through computer modeling.

“Animal testing just takes a long time and what we need to do is think about ways to shorten it, he said in an interview after delivering a presentation at homeland security conference here jointly sponsored by the Institute for Foreign Policy Analysis and the Fletcher School of Law and Diplomacy of Tufts University.

“Can we do more laboratory scale things where we’re working at the cell level? And then ultimately, if our computational biology comes along, could we use it to run through some of the studies that have been done?” he said.

During the presentation, he issued a “plea for help” to the regulatory community, encouraging them to “think toward more novel ways” to approve biodefense drugs and vaccines, such as through those methods.

Debate Persists

Bush administration officials have argued that difficulties in approving such products for the market have discouraged U.S. pharmaceutical companies from investing sufficiently in the field, slowing the development of defenses.

Critics have argued that efficacy testing on humans should be required to ensure that drugs and vaccines are safe and reliable.

Until a change in 2002, Food and Drug Administration (FDA) regulations required that vaccine efficacy be demonstrated on humans, posing a challenge for approving biodefense vaccines quickly.

The FDA announced in late 2002, however, a regulation change allowing for drugs and vaccines to be marketed based partially on efficacy testing using animals (see GSN, June 4, 2002).

A federal judge ruled last week that that the Defense Department should stop administering the anthrax vaccine to military personnel, finding that the Food and Drug Administration did not meet its own review standards on safety and effectiveness before allowing use of the vaccine (see GSN, Oct. 28).

Gallaway said the court ruling would probably make companies “more conservative than ever. So we’ve got that working against us as well,” he said.

Looking Toward the Future

In the interview, Gallaway said there are no technologies currently available that could substitute for human and animal testing and that he was encouraging the regulatory community to lay the groundwork for acceptance of alternatives when they become available.

“What I’m looking for is, as we get better, [and] our technical skills are such that we could use things, I don’t want them to all of a sudden say, ‘Now I’ve got to think about the regulatory side,’” he said, “because then we’d have a hiatus before we could use it.”

It took years for the FDA to approve the change allowing for efficacy testing on primates.

“If we could get them starting to think about it, maybe in parallel [with the research], by the time we’re capable of doing that, then they’d agree that yes, they could tolerate that in their licensing process,” he said.

For example, he suggested that someday computer simulations might be capable of modeling the human body with sufficient realism to serve as an alternative to human and animal testing.

 “Let me take you to an extreme, what would happen if we could model the human body, recall it in silica, computer modeling of the human body. If you had a perfect model of the human body, you could do the same kinds of things that we do with experiments,” he said.

“Now we’re a long ways from that, but we’ve got to start down that road,” he said.


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chemical

Iraqi Insurgents Threaten Chemical Attacks Against U.S. Forces


Iraqi insurgents in the city of Fallujah said yesterday that they had added chemicals to munitions they would use against U.S. forces preparing to attack the city, the London Sunday Times reported (see GSN, Oct. 12).

Insurgent commanders said that some of the munitions contained cyanide, according to the Times. A group of former Iraqi military officers, including chemical weapons experts, are rumored to have aided in organizing insurgents in Fallujah and planning tactics, the Times reported (Hala Jaber, London Sunday Times, Oct. 31).

Meanwhile, a report released last month by U.S. chief weapons inspector in Iraq Charles Duelfer said that looters in Iraq last year ransacked a site where a bunker contained old chemical weapons, according to the Associated Press.

All bunkers previously sealed by U.N. inspectors at the Muthanna State Establishment, a former key site in Iraq’s past chemical weapons program, were looted, according to Duelfer’s report. It is unknown, though, whether any usable chemical weapons were at the site at the time it was looted, according to AP.

“Clearly, there’s a potential concern, but we’re unable to estimate the relative level of it because we don’t know the condition of the things inside the bunker,” said Ewen Buchanan, spokesman for the U.N. Monitoring, Verification and Inspection Commission.

Duelfer told AP Friday that he was unaware of “anything of importance” taken from the site (Charles Hanley, Associated Press/Yahoo!News, Oct. 30).


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Russia Set to Destroy 20 Percent of Chemical Arsenal by 2007, Official Says


Russia plans to fulfill its obligation under the Chemical Weapons Convention to destroy 20 percent of its chemical weapons arsenal by the end of April 2007, Russian Foreign Ministry spokesman Alexander Yakovenko said Saturday (see GSN, Sept. 24).

Russia has presented the executive council of the Organization for the Prohibition of Chemical Weapons, which oversees the treaty, with “information on the course of the destruction of chemical weapons in our country and on the construction of new facilities for this purpose,” Yakovenko said (ITAR-Tass/BBC Monitoring, Oct. 30).

 


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