|
| ||||||||
| ||||||||
|
Center for Biosecurity letter of support for H.R. 6671, the Select Agent Program and Biosafety Improvement Act of 2008 |
The Honorable Jane Harman 2400 Rayburn House Office Building Washington, DC 20515-0536 | The Honorable Mike Rogers 133 Cannon House Office Building Washington, DC 20515-2208 |
Dear Representatives Harman and Rogers,
The leadership and staff of the Center for Biosecurity of the University of Pittsburgh Medical Center (UPMC) thank you and your colleagues for your leadership in introducing H.R. 6671, 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 securely and 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:
- Select Agent Program evaluation: Scrutiny of the Select Agent Program is of key importance following the FBI’s assertion that the 2001 anthrax attacks came from a biodefense research laboratory. The Act calls for an evaluation of the program to ensure that it is indeed enhancing biosecurity and biosafety while promoting scientific advances. A thorough evaluation of the program could also suggest improvements in oversight and accountability.
- 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, maximize the use of specialized facilities of some laboratories, and result in increased safety of the research.
- Improving training for laboratory workers, developing minimum standards for biosafety training: As new high-containment laboratories become operational in the coming years, additional qualified staff will also be needed. Conventional 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 training new staff on safety practices. It could also conserve experienced mentors’ valuable time and abilities and shorten the time it takes for 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’ were 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 be avoided. Thus, it is an important step forward that the Act requires HHS and USDA to establish a voluntary reporting system that can clear these barriers so biosafety can be enhanced through shared learning from operational experiences, and so that the public can be reassured that accidents are being thoroughly examined and contained.
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 examples of 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. Edward Kennedy
Senator Richard Burr
House Subcommittee on Intelligence, Information Sharing and Terrorism Risk Assessment
Representative Norman D. Dicks
Representative James R. Langevin
Representative Christopher P. Carney
Representative Ed Perlmutter
Representative Bennie G. Thompson
Representative David G. Reichert
Representative Christopher Shays
Representative Charles W. Dent
Representative Peter T. King
House Committee on Agriculture
Representative Collin C. Peterson
Representative Bob Goodlatte
House Committee on the Judiciary
Representative John Conyers, Jr.
Representative Lamar Smith
House Energy and Commerce
Representative John D. Dingell
Representative Joe Barton
Members of the Subcommittee on Health, Energy and Commerce
Representative Frank Pallone, Jr.
Representative Nathan Deal
Representative Henry A. Waxman
Representative Edolphus Towns
Representative Bart Gordon
Representative Anna Eshoo
Representative Gene Green
Representative Diana DeGette
Representative Lois Capps
Representative Tom Allen
Representative Tammy Baldwin
Representative Eliot L. Engel
Representative Jan Schakowsky
Representative Hilda L. Solis
Representative Mike Ross
Representative Darlene Hooley
Representative Anthony D. Weiner
Representative Jim Matheson
Representative John D. Dingell
Representative Ralph M. Hall
Representative Barbara Cubin
Representative Heather Wilson
Representative John B. Shadegg
Representative Steve Buyer
Representative Joseph R. Pitts
Representative Mike Ferguson
Representative Mike Rogers
Representative Sue Wilkins Myrick
Representative John Sullivan
Representative Tim Murphy
Representative Michael C. Burgess
Representative Marsha Blackburn
Representative Joe Barton
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 Patrick Kennedy
Members of the Senate HELP Committee
Senator Edward Kennedy
Senator Christopher Dodd
Senator Tom Harkin
Senator Barbara A. Mikulski
Senator Jeff Bingaman
Senator Patty Murray
Senator Jack Reed
Senator Hillary Rodham Clinton
Senator Barack Obama
Senator Bernard Sanders
Senator Sherrod Brown
Senator Michael B. Enzi
Senator Judd Gregg
Senator Lamar Alexander
Senator Richard Burr
Senator Johnny Isakson
Senator Lisa Murkowski
Senator Orrin G. Hatch
Senator Pat Roberts
Senator Wayne Allard
Senator Tom Coburn
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