[Congressional Record Volume 155, Number 34 (Thursday, February 26, 2009)]
[Senate]
[Pages S2559-S2561]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. BURR (for himself and Mr. Kennedy):
  S. 485. A bill to reauthorize the Select Agent Program by amending 
the Public Health Service Act and the Agriculture Bioterrorism 
Protection Act of 2002 and to improve oversight of high containment 
laboratories; to the Committee on Health, Education, Labor, and 
Pensions.
  Mr. BURR. Mr. President, I rise today in support of S. 485, the 
Select Agent Program and Biosafety Improvement Act of 2009. Today, I 
reintroduced this important legislation with my friend Senator Ted 
Kennedy. We first introduced this bill in June 2008. 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 United States 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.
  This bill will enhance our nation's biosecurity and improve the 
biosafety of our most secure laboratories. We must do everything we can 
to make sure that biological agents and toxins that could present a 
serious threat to public health are kept safe and secure in containment 
laboratories and out of the hands of terrorists.
  In December 2008; 6 months after we introduced this legislation for 
the first time, the bipartisan Commission on the Prevention of WMD 
Proliferation and Terrorism reported it is ``more likely than not'' 
that a weapon of mass destruction will be used in a terrorist attack by 
the end of 2013. The Commission's report, World at Risk, found that 
terrorists are more likely to obtain and use a biological weapon than a 
nuclear weapon and, therefore, the U.S. government should make 
bioterrorism a higher priority. According to the report, ``Only by 
elevating the priority of the biological weapons threat will it be 
possible to bring about substantial improvements in global 
biosecurity.'' Many of the specific recommendations contained in that 
report are reflected in this legislation.
  S. 485 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

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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.
  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 important life-saving 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 
February 2009, there are 82 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 336 entities 
and 10,463 individuals registered with the CDC to work with select 
agents and toxins, and 64 entities and 4,149 individuals registered 
with APHIS.
  We take four key actions in S. 485 to strengthen the Select Agent 
Program.
  First, our legislation reauthorizes the program through 2014 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. This is timely because the WMD Commission recently 
suggested the need for an interagency review of the Select Agent 
Program and its impact on biological security and legitimate scientific 
research. Historically, the United States has been an international 
leader in biosecurity. In fact, last year Canada proposed legislation 
to tighten safety and access to pathogens and toxins of concern for 
bioterrorism. Canada's legislation, which was reintroduced earlier this 
month, 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, ``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 bioterrorism 
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. 485 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 safer 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 that 
laboratory workers and the public can be assured that 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. In addition, the 
recent report by the WMD Commission called for HHS and DHS to lead an 
interagency effort to tighten government oversight of high-containment 
labs.
  Second, the bill improves training for laboratory workers. The WMD 
Commission report also called for standard biosafety and biosecurity 
training for all personnel who work in high-containment labs and 
funding the development of such educational materials. As the number of 
laboratories and personnel increases, we must ensure workers are 
appropriately trained. 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. The WMD 
Commission recommended promoting a culture of security awareness in the 
life sciences community and establishing whistleblower mechanisms 
within the life sciences community so that scientists can report their 
concerns about safety and security without risk of retaliation. We 
believe such a reporting system would help fulfill this recommendation.
  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. 485, the Select Agent and Biosafety Improvement 
Act of 2009. I want to 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

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look forward to working with my colleagues to reauthorize and improve 
the program.
                                 ______