New Bio-Terrorism Bill Would Reshape U.S. Bio-Defense Efforts

On September 8, 2009, the Senate Homeland Security and Governmental Affairs Committee introduced an ambitious, wide-ranging bill to address the acute threat of catastrophic terrorism, with a particular focus on addressing the threat posed by biological weapons and toxins.  If passed, the bill’s provisions could significantly impact the research community and the private sector in the United States and would commit the U.S. government to a larger, more-coordinated international effort to address the global bio-defense challenge.  The Senate’s bill implements the recommendations of the congressionally mandated Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, which released its highly regarded report, “World at Risk,” in December 2008.   

Numerous U.S. federal agencies would be involved in implementing the bill’s requirements.  The proposed legislation, known as the “Weapons of Mass Destruction (WMD) Prevention and Preparedness Act of 2009,” would, among other things, do the following—

• identify and categorize the most deadly pathogens that could be used as biological weapons and provide government grants to laboratories that work with such agents to upgrade security measures
  
  
• direct the Department of Homeland Security (DHS) to develop higher training and risk assessment standards for laboratories handling dangerous pathogens and establish penalties for laboratories that fail to comply with the more-stringent regulations
  
  
• require the Department of Health and Human Services (HHS) to create a database of laboratories that handle pathogens that potentially could pose a public health, security or environmental threat
  
  
• create a National Bio-Forensics Analysis Center to aid in identifying the perpetrators of bio-terror attacks
  
  
• develop a national system for distributing medicines and antibiotics in case of a biological attack
  
  
• expand an existing U.S. Postal Service program to distribute medicine and supplies to five additional cities in the first year and 15 more cities in two years.

Sen. Joseph Lieberman, I-Conn., the committee chairman, expects to move the bill through the Homeland Security and Governmental Affairs Committee soon and hopes for Senate passage by the end of the year.  The House of Representatives has yet to introduce a similar measure.  If passed, the bill has the potential to subject to regulation a broad array of laboratories and companies—including entities that have only an indirect connection with dangerous biological pathogens (or none at all)—by means such as registration for a proposed HHS database.  The reach of the bill also extends abroad, namely by directing the secretary of state to create an International Bio-Security Coalition that would provide training and laboratory security assistance to other countries. 

With such a far-reaching bill making its way through the U.S. Congress, the biotech and broader medical research community would be well-advised to stay abreast of this potentially important piece of legislation.