LEGISLATION: Bio-Terror Legislation (2001), Bio-Terror Legislation (2002), Bio-Terror Legislation (2003), Bio-Terror Legislation (2004), Bio-Terror Legislation (2005), Bio-Terror Legislation (2010), Bio-Terror Legislation (2011), and Bio-Terror Legislation (2012).
Date: January 27, 2010
Source: White House
Abstract: That's the leadership that we are providing –- engagement that advances the common security and prosperity of all people. We're working through the G20 to sustain a lasting global recovery. We're working with Muslim communities around the world to promote science and education and innovation. We have gone from a bystander to a leader in the fight against climate change. We're helping developing countries to feed themselves, and continuing the fight against HIV/AIDS. And we are launching a new initiative that will give us the capacity to respond faster and more effectively to bioterrorism or an infectious disease -– a plan that will counter threats at home and strengthen public health abroad (White House, 2010).
Title: Ireland Calls For Tougher Restrictions On Bioweapons
Date: February 11, 2010
Source: Bio Prep Watch
Abstract: A spokesman for Ireland’s Labour Party has called for new legislation banning biological weapons to also include the prohibition of transmission of bioweapons through Irish airspace.
“There is evidence of the use of biological weapons in practically every other major conflict, so this legislation is urgent,” a Labour TD told the Irish Times. “It is very important that we not only prohibit any work in this regard but also, as a country interested in international law, that we bring forward the legislation dealing with Shannon
Ireland’s Cabinet approved the Biological Weapons Bill this week, which prohibits the use, development, production, manufacture, possession, stockpiling, acquisition and retention or transfer of biological weapons.
Ireland’s new ban will apply to all vessels and aircraft registered in Ireland as well as to members of the Defence Forces and citizens of Ireland outside of the nation.
Michael Higgins, the spokesman on foreign affairs for Labour, told the Irish Times that the bill, as it currently stands, does not extend the ban to the transmission of biological weapons through Shannon and other airports.
Higgins also said that the bill should be brought forward
in conjunction with the newly announced Air Navigation Bill, which is being
discussed by the Cabinet subcommittee on extraordinary rendition (Bio
Prep Watch, 2011).
Title: Biosecurity Laws Hobble Research
Date: May 10, 2010
Source: The Scientist
Abstract: Ever since the U.S. government has taken steps to protect and encourage research involving pathogens that could be used as biological weapons, that research has become much less efficient, according to a new analysis.
Title: Regulations Increase Cost Of Dangerous-Pathogen Research
Date: May 10, 2010
Abstract: Complex US regulations governing experiments with dangerous pathogens and toxins have reduced research efficiency, according to a study published in the Proceedings of the National Academy of Sciences1 this week. The average cost of a research paper on the Ebola virus has increased from about US$59,000 to $333,000 since the restrictive regulations were adopted in 2001–02.
But more researchers have entered the field and the number of publications has increased, despite concerns from some microbiologists that regulations were driving talented scientists away (see Driven out of research).
"Some of the worst fears about regulation becoming so intrusive that things couldn't get done have probably not been realized," says Kenneth Berns, a virologist at the University of Florida, Gainesville, and a member of the National Science Advisory Board for Biosecurity in Bethesda, Maryland.
The study, led by Elizabeth Casman of Carnegie Mellon University in Pittsburgh, Pennsylvania, evaluated the effects of two government acts on biomedical research — the Bioterrorism Preparedness and Response Act of 2002, and the USA PATRIOT Act that was passed about six weeks after the terrorist attacks on 11 September 2001. The two laws limit research with 'select agents' — pathogens such as Bacillus anthracis and toxins such as ricin that could potentially be used as bioweapons — and their measures include researcher background checks and training, protocols for handing the agents and extensive documentation at every stage of the research.
Some researchers decried the regulations, saying that they went too far and would smother the research needed to understand and develop treatments for biothreats. "We all agree that we need to be careful," says Arturo Casadevall, a microbiologist who works with B. anthracis at the Albert Einstein College of Medicine of Yeshiva University in New York. "But it is very difficult. The paperwork required is enormous."
In a survey published in 2009, 64% of 198 biodefence researchers reported a high level of concern that they might unintentionally violate the regulations and damage their careers in the process..
In the latest research, Casman and her colleagues gathered data on research publications involving two select agents: the Ebola virus and B. anthracis. They found that most researchers had started working with the pathogens after the biosecurity regulations were enacted, suggesting an influx of scientists into the field — even after accounting for a natural rise in research due to funding increases for the work.
This trend was not seen with authors of publications about Klebsiella pneumoniae, a bacterium that can infect people with weakened immune systems. Although concerns about the spread of antibiotic-resistant K. pneumoniae have stimulated research in the field, the bacterium is unlikely to be of use to terrorists and is not a select agent.
The number of collaborations for research into Ebola virus and B. anthracis — within the United States and internationally — has also grown, although international collaborations occur with fewer countries now that the biosecurity regulations are in place.
Despite these gains, there are signs that the procedures are a burden on the research community. Before 2002, there were 17 papers published on Ebola research for every $1 million spent. This fell to three papers per $1 million after 2002. The average number of K. pneumoniae publications fell only from 26 to 17 under the same conditions.
One problem with the policies is that some were based on the measures used to regulate nuclear-weapons research, says Vickie Sutton, director of the Center for Biodefense, Law and Public Policy at Texas Tech University in Lubbock.
For example, regulations require researchers to create an inventory of each sample of a select agent and to document any changes. A missing test tube would draw immediate attention from the US Centers for Disease Control and Prevention, says Sutton. But the system does nothing to prevent the use of samples withdrawn from a live culture to seed a new culture. "You could every day be giving this agent out to someone," she says. "It's nonsense."Nevertheless, studies such as Casman's strengthen the case for streamlining the regulations. Some important steps have already been taken, says Casadevall. In 2008, for example, the US Department of Agriculture removed several plant pathogens from the select-agents list after they were deemed by researchers to pose little threat. "I'm optimistic that we'll work this out," he says, "but it will take time" (Nature, 2010).
Title: Study: Patriot Act Made Anthrax Research 5-6x More Expensive
Date: May 11, 2010
Abstract: The USA Patriot Act and the Bioterrorism Preparedness Act, both enacted not long after the 9/11 attacks, contained measures to make it harder for anybody to get their hands on the kind of pathogens one might need to launch a bioterror attack. There was just one problem: The rules also slowed down and constrained our own scientists’ abilities to learn about those pathogens, according to a study out this week in the Proceedings of the National Academy of Sciences.
To be specific, lead researcher Elizabeth Casman found while there was a touch of good news—the laws didn’t appear to deter new scientists from entering the field—the major effect of those acts has been to make research on ebola virus and anthrax much more expensive, and much slower.
The researchers did find an increase in
the total number of papers published. But before the laws, 17 anthrax
papers appeared per million dollars of funding. With the restrictions,
only three papers appeared per million dollars of funding. For ebola,
the numbers dropped from 14 to six papers per million dollars. Figures
for the control stayed the same
In other words, a scientific paper on anthrax became five or six times more expensive, and a paper on ebola twice as expensive. And a lot of the problem is simply the exhaustive record-keeping required.
The laws’ new regulations govern the exhaustive documentation of the transportation, guarding, and use of select agents. As a result, they are burying researchers studying select agents with administrative duties, Casman noted. Researchers to whom Casman spoke “all complained of the paperwork,” she said. “A lot of it, they just find overwhelming”.
One might argue that the paperwork headaches are worth it if they keep our samples of deadly pathogens secure (especially after an affair like the Bruce Ivins case, in which the longtime Army researcher was convicted for was the lead suspect in the 2001 anthrax attacks before he died in 2008 in an apparent suicide). But biodefense policy expert Vickie Sutton told Nature that the Patriot Bioterrorism Preparedness acts aren’t securing out lab supplies of ebola and anthrax—they’re just slowing down our own knowledge about them.
For example, regulations require
researchers to create an inventory of each sample of a select agent and
to document any changes. A missing test tube would draw immediate
attention from the US Centers for Disease Control and Prevention, says
Sutton. But the system does nothing to prevent the use of samples
withdrawn from a live culture to seed a new culture. “You could every
day be giving this agent out to someone,” she says. “It’s nonsense” (Discovery, 2010).