The Congressional Record is a unique source of public documentation. It started in 1873, documenting nearly all the major and minor policies being discussed and debated.
“SELECT AGENT PROGRAM AND BIOSAFETY IMPROVEMENT ACT” mentioning the U.S. Dept of Agriculture was published in the Senate section on pages S5686-S5687 on June 17, 2008.
The publication is reproduced in full below:
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 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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