[Congressional Record (Bound Edition), Volume 154 (2008), Part 9]
[Senate]
[Pages 12568-12569]
[From the U.S. Government Publishing Office, www.gpo.gov]




           SELECT AGENT PROGRAM AND BIOSAFETY IMPROVEMENT ACT

  Mr. BURR. Mr. President, I rise today in support of S. 3127, the 
Select Agent Program and Biosafety Improvement Act of 2008. Last week, 
I introduced this important legislation with my friend Senator Ted 
Kennedy. I thank my colleague from Massachusetts for his partnership. I 
enjoyed working closely with him in the 109th Congress on the Pandemic 
and All-Hazards Preparedness Act, which was signed into law in December 
2006. He continues to be one of the great leaders in the U.S. Senate 
and I look forward to continuing to work with him to ensure our laws 
protect the American people from health threats of all kinds.
  S. 3127 will enhance our Nation's biosecurity and improve the 
biosafety of our most secure laboratories. The bill achieves two 
overarching goals.
  First, it reauthorizes and improves the Select Agent Program. This 
program was created in the 1990s to control the transfer of certain 
dangerous biological agents and toxins that could be used for 
bioterrorism. The program expanded after the anthrax attacks in 2001; 
however, the authorization expired at the end of September 2007.
  Second, the bill evaluates and enhances the safety and oversight of 
high containment laboratories. These laboratories are used by 
scientists to study select agents and other infectious materials. Labs 
are categorized by their safety level. There are four levels, termed 
Biosafety Level, BSL, 1 through 4, with 4 being the highest level. The 
number of these labs has grown, both domestically and internationally, 
in the last several years. Recent incidents in which laboratory workers 
were exposed to disease agents have highlighted the need to evaluate 
ways to improve the safety of these labs.
  The Select Agent Program is jointly administered by the U.S. 
Department of Health and Human Services', HHS, Centers for Disease 
Control and Prevention, CDC, and the U.S. Department of Agriculture's, 
USDA, Animal and Plant Health Inspection Service, APHIS. The program 
was intended to prevent terrorism, and protect public and animal health 
and safety, while not hampering legitimate research. This is an obvious 
struggle that requires careful consideration, particularly when science 
is rapidly advancing around the globe.
  Under the USA PATRIOT Act, it is illegal to possess ``select agents'' 
for reasons other than legitimate research. The Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002 further required 
laboratories and laboratory personnel to undergo background checks by 
the FBI prior to approval for possession of select agents. As of April 
2008, there are 72 select agents, meaning the agents pose a severe 
threat to public or animal health and safety. Thirteen of these agents 
are found naturally in the United States. There are 325 entities and 
9,918 individuals registered with the CDC to work with select agents 
and toxins, and 75 entities and 4,336 individuals registered with 
APHIS.
  We take four key actions in S. 3127 to strengthen the Select Agent 
Program.
  First, our legislation reauthorizes the program through 2013 and 
calls for a comprehensive evaluation of the program. The review, to be 
conducted by the National Academy of Sciences, will look at the effects 
of the program on international scientific collaboration and domestic 
scientific advances. Historically, the United States has been an 
international leader in biosecurity. In fact, Canada recently proposed 
legislation to tighten safety and access to pathogens and toxins of 
concern for bioterrorism. Canada's new legislation, released in April 
2008, would establish a mandatory licensing system to track human 
pathogens, similar to our Select Agent Program. It also ensures 
compliance with the country's Laboratory Biosafety Guidelines across 
the country.
  Second, the bill ensures a comprehensive list of select agents. 
Currently, CDC and APHIS develop a list of agents and toxins to which 
the program regulations apply. However, we believe some additional 
factors should be considered in revising the list. For example, 
scientific developments now make it possible to create agents from 
scratch or to modify them and make them more deadly. Highly infectious 
viruses or bacteria that are otherwise difficult to obtain can now be 
created by scientists using ``synthetic genomics''. In addition, we now 
have more information from the Department of Homeland Security, DHS, 
about the threat posed by certain bioterrorism agents.
  In 2002, U.S. researchers assembled the first synthetic virus using 
the genome sequence for polio. Later, in 2005 scientists reconstructed 
the 1918 pandemic influenza virus. Then in January 2008, a ``safe'' 
form of Ebola was created synthetically. While this ``safe'' Ebola can 
be used for legitimate research to develop drugs and vaccines to 
protect against it, a scientist could also change it back to its lethal 
form. Also, earlier this year, advancements in technology yielded the 
first synthetic bacterial genome.
  We must consider these scientific advances, including genetically 
modified organisms and agents created synthetically, if we are to 
address all agents of concern. In addition, DHS's recent biological 
risk assessments provide new information for our assessment of 
biological threats. This information should also be considered when 
determining which agents and toxins should be regulated.
  Next, the bill encourages sharing information with State officials to 
enable more effective emergency State planning. State health officials 
are currently not made aware of which agents are being studied within 
their State. This leaves medical responders, public health personnel, 
and animal health officials unprepared for a potential release, whether 
accidental or intentional.
  Lastly, S. 3127 clarifies the statutory definition of smallpox. The 
Intelligence and Terrorism Prevention Act of 2004 criminalized the use 
of variola virus, the agent that causes smallpox. The statutory 
definition of the virus includes agents that are 85 percent identical 
to the causative strain. Researchers are worried this could be 
interpreted to also include the strain used to develop the smallpox 
vaccine, as well as less harmful naturally occurring viruses. This sort 
of ambiguity could be detrimental to necessary medical countermeasure 
research and development. Our bill requires the Attorney General to 
issue guidance clarifying the interpretation of this definition.
  In addition, in this legislation we take three key actions to 
evaluate and enhance the safety and oversight of high containment 
laboratories.
  First, our bill evaluates existing oversight of BSL 3 and 4, or high 
containment, labs. The bill requires an assessment of whether current 
guidance on infrastructure, commissioning, operation, and maintenance 
of these labs is adequate. As I mentioned, the number of these labs is 
increasing around the globe. As these new facilities age, we need to 
make sure they are appropriately maintained. It is essential

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that laboratory workers and the public know these facilities are as 
safe as possible. If the guidance we currently have in place is not 
adequate, then we need to know how to improve it.
  Second, the bill improves training for laboratory workers. As the 
number of laboratories and personnel increases, we must ensure workers 
are appropriately trained and lab accidents to not increase. Accidents 
and injuries in the lab, such as chemical burns and flask explosions, 
may result from improper use of equipment. Our bill develops a set of 
minimum standards for training laboratory personnel in biosafety and 
biosecurity, and encourages HHS and USDA to disseminate these training 
standards for voluntary use in other countries.
  Finally, the bill establishes a voluntary Biological Laboratory 
Incident Reporting System. This system will encourage personnel to 
report biosafety and biosecurity incidents of concern and thereby allow 
us to learn from one another. Similar to the Aviation Safety Reporting 
System, which gathers information on aviation accidents, this system 
will help identify trends in biosafety and biosecurity incidents of 
concern and develop new protocols for safety and security improvements. 
Lab exposures to pathogens not on the select agent list will also be 
captured through this type of voluntary reporting system.
  In closing, I encourage my Senate colleagues to join Senator Kennedy 
and me as we work to improve our Nation's biosecurity and biosafety 
systems by passing S. 3127, the Select Agent and Biosafety Improvement 
Act of 2008. I thank the many researchers, scientists, and State health 
officials from across the country who shared with me and my staff their 
ideas, experiences, and recommendations. In this time of exciting 
scientific advances, we must ensure our laws and prevention programs 
are updated to reflect current conditions. In addition, we must remain 
vigilant in our efforts to protect the American people from 
bioterrorism. The Select Agent Program is an important part of ensuring 
the Nation's safety and security and I look forward to working with my 
colleagues to reauthorize and improve the program.

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