Center for Biosecurity letter of support for the Select Agent Program and Biosafety Improvement Act of 2008 

The Center for Biosecurity of UPMC has endorsed the Select Agent Program and Biosafety Improvement Act of 2008 (s. 3127), introduced by Senators Burr and Kennedy on June 12, 2008. If passed, this important piece of legislation will ensure that needed biodefense research can proceed, without compromises to the quality of the research, laboratory worker safety or the safety of the communities surrounding the laboratories.

In addition to reauthorizing the Select Agent Program, this legislation will improve training for personnel in high containment laboratories and establish a voluntary incident reporting system for biosafety accidents and mishaps—all measures previously advocated by the Center. (See also: Dr. Gigi Kwik Gronvall’s testimony before the U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Oversight and Investigations; and, "High-Containment Biodefense Research Laboratories: Meeting Report and Center Recommendations.") The legislation also calls for an analysis of the effectiveness of the Select Agent Program, in particular the effect on international scientific collaborations and the advance of science.

June 17, 2008
   

Dear Senators Burr and Kennedy:

The leadership and staff of the Center for Biosecurity of the University of Pittsburgh Medical Center (UPMC) would like to thank you and your colleagues in the Congress for your leadership on biodefense issues. A clear example is The Select Agent Program and Biosafety Improvement Act of 2008. The Center for Biosecurity strongly supports and endorses this bill. It is an important piece of legislation that would ensure that needed biodefense research can proceed, without compromises to the quality of the research, laboratory worker safety, or the safety of the communities surrounding the laboratories.
Among the many important parts of this Act are the following:

• Evaluation of ways to improve oversight of biocontainment laboratories: High-containment laboratories are necessary if we are to produce the scientific advances needed to develop medical countermeasures against bioweapons and emerging diseases. However, recent highly publicized laboratory errors and siting controversies have raised questions about whether the governing framework, oversight, and standards for biosafety and biosecurity measures are adequate. The Select Agent Program and Biosafety Improvement Act of 2008 calls for an evaluation of the siting and oversight of biocontainment laboratories, and will address topics such as lessons learned, commissioning, operation, maintenance, and worker training. Gathering this information and improving upon the program has the potential to speed up the process for newly constructed laboratories to become productive; it could maximize the use of specialized facilities of some laboratories; and it could result in increased safety of the research.
• Improving training for laboratory workers, developing minimum standards for biosafety training: As the new high-containment laboratories become operational in the coming years, additional qualified staff will also be needed. The usual methods of biosafety training for high-containment research—that is, intensive one-on-one training within a mentor-apprentice relationship—will likely not be sufficient to handle the influx of researchers and technicians into the field. Core competencies and standards for biosafety and biosecurity, the requirement of which is written into the Act, would be useful and important for the training of new staff on safety practices. It could also conserve the experienced mentors’ valuable time and abilities and shorten the time it takes for the labs to become productive.
• Biological Laboratory Incident Reporting System: Generally, there is a disincentive to report laboratory acquired infections and other mishaps at research institutions. Infections lead to negative publicity and scrutiny from the granting agency, adversely affecting future research funding. In addition, after a scientist acquires an infection in the laboratory, neither the scientist nor the laboratory wishes to advertise the mistake. Many experts believe that nonlethal infections are underreported, and operational problems or ‘near misses’ are generally not reported. Without reporting, and without analysis of these incidents, lessons cannot be learned from the experience. Laboratory procedures cannot be analyzed in light of the accidents, so that future accidents can potentially be avoided. Thus, it is an important step forward that the Act requires HHS and USDA to establish a voluntary reporting system, which has the potential to clear these barriers so biosafety can be enhanced through shared learning from operational experiences, and also so the public may be reassured that accidents are being thoroughly examined and contained.

In addition to these important safety considerations for high-containment laboratories, a program evaluation for the Select Agent Program, included in the Act, is an essential step towards ensuring that the Select Agent Program enhances biosecurity and biosafety, while promoting scientific advances. A thorough evaluation of the program could suggest improvements that increase productivity. For biodefense to be held to high scientific standards and for it to be successful in promoting the development of medical countermeasures, the program will also need to promote international scientific collaboration. 

Protecting the nation against destabilizing large-scale epidemics, whether natural or man-made, is an urgent priority. The anthrax attacks in 2001, the SARS epidemic in 2003, and the current threat of avian influenza all are important reasons why we must conduct research to determine how microbes work and how to defeat them with medicines and vaccines. The Select Agent Program and Biosafety Improvement Act of 2008 sets the stage for achieving biosafety and biosecurity goals while continuing to advance our knowledge and control of these deadly diseases.

Again, thank you for your leadership on this important national security and public health issue. The Center for Biosecurity appreciates your leadership in introducing this important piece of legislation and stands ready to work with you to see it enacted. Please feel free to contact us if you have any questions or concerns.

Sincerely,

Gigi Kwik Gronvall, PhD
Senior Associate
Center for Biosecurity of UPMC

   
Thomas V. Inglesby, MD
Chief Operating Officer and Deputy Director
Center for Biosecurity of UPMC

   
Tara O’Toole, MD, MPH
Chief Executive Officer and Director
Center for Biosecurity of UPMC

   
cc:
Senator Tom Harkin
Senator Arlen Specter

Members of the Subcommittee on Oversight and Investigations, Energy and Commerce:

Representative Bart Stupak
Representative Charlie Melancon
Representative John Shimkus
Representative Diana DeGette
Representative Henry A. Waxman
Representative Gene Green
Representative Mike Doyle
Representative Jan Schakowsky
Representative Jay Inslee
Representative Ed Whitfield
Representative Greg Walden
Representative Tim Murphy
Representative Michael C. Burgess
Representative Marsha Blackburn
Representative Joe Barton

Representative John Dingell
Representative Bennie G. Thompson
Representative Peter T. King
Representative Patrick Kennedy

United States Department of Agriculture:

Ed Schafer, Secretary of USDA
Freeda Isaac, Director, Select Agent Program

Secretary Mike Leavitt, HHS

Centers for Disease Control and Prevention:

Julie Gerberding, Director
Richard E. Besser, Director, Coordinating Office for Terrorism Preparedness and Emergency Response
Casey Chosewood, Director, Office of Health and Safety, Office of the Director Captain Robbin S. Weyant, Director, Division of Select Agents and Toxins

National Institutes of Health:

Elias Zerhouni, Director
Anthony S. Fauci, Director, NIAID
Hugh Auchincloss, Deputy Director, NIAID
Mike Kurilla, Director, Office of BioDefense Research Affairs and Associate Director for BioDefense Production Development, NIAID
Amy Patterson, Director, Office of Biotechnology Activities, NIH
Deborah E. Wilson, Director, Division of Occupational Health and Safety, Office of Research Services, NIH

Robert Kadlec, Special Assistant to President for Homeland Security and Senior Director for Biological Defense Policy