1. BSAF-BIONET Meeting Robert J. Hashimoto, CBSP University of California, Berkeley October 2, 2009

2. On September 22, 2009, the Senate passed a bill resulting in the Weapons of Mass Destruction Prevention and Preparedness Act of 2009, S 1649. The purpose of this Standard is to improve management of the existing Select Agent Program with the inclusion of the Department of Homeland Security and the creation of a tiered system to manage the agents of consequence.

3. The new law is designed to minimize the potential for an attack and would also improve emergency response capabilities. The impact of improved security standards for laboratories will also be addressed as the concept of personnel reliability is introduced as a personnel management tool in conjunction with the existing Department of Justice background check requirement.

4. This roundtable is designed for the audience to address questions and concerns with this proposed legislation. Comments that have been made at the meeting may be forwarded to the American Biological Safety Association (ABSA) to the ABSA Technical Review Committee for consideration and inclusion for official comment.

5. Since the time allotted for the roundtable is rather short, let us introduce the moderators for today’s session:  Bob Hashimoto-UC Berkeley  David Silberman-Stanford University

6.  The Standard consists five titles: ◦ TITLE I: ENHANCING BIOSECURITY ◦ TITLE II: RESPONSE TO A WEAPON OF MASS DESTRUCTION ATTACK ◦ TITLE III: INTERNATIONAL MEASURES TO PREVENT BIOLOGICAL TERRORISM ◦ TITLE IV: GOVERNMENT ORGANIZATION ◦ TITLE V: EMERGENCY MANAGEMENT AND CITIZEN ENGAGEMENT THE STANDARD

7. For the sake of time for discussion, I will try to briefly summarize the key section that may affect the biosafety professional and the Biosafety Program; Section I primarily would affect the existing Select Agent Programs and consequently, it will be the focus of the roundtable will be in this section; comments or concerns with regard to the other four sections will be made after the discussion of Title I-Enhancing Biosecurity.

8. Sect. 101: Designation of Tier I Agents  This section authorizes the HHS Secretary to establish a Tier I designation for pathogens that have significant potential to be used effectively in a biological attack and to consider whether they require additional biosecurity measures.  This section authorizes the Secretary of Agriculture to establish a Tier I designation for those pathogens affecting agriculture consistent with those measures described for pathogens affecting human health.

9. Sect. 102: Enhanced Biosecurity Measures  This section authorizes the Department of Homeland Security Secretary to establish biosecurity standards for laboratories handling Tier I pathogens through negotiated rule-making that includes research institutions.  These biosecurity standards shall include but not be limited to a personnel reliability program, staff training, risk assessments, and sharing security information with State, local, and tribal governments.  The rule-making process minimize disincentives to biological research. This section also directs how the promulgated standards shall be implemented. For example, DHS and HHS shall jointly inspect laboratories handling public health Tier I pathogens, and DHS and the USDA shall jointly inspect laboratories handling agricultural Tier I pathogens.

10. Sect. 103: Biological Laboratory Registration  This section authorizes the establishment of a single database program of all biological laboratories working with Select Agent pathogens.  It shall require the registration and inclusion in the database of those biological laboratories and facilities whose registration would assist in improving security, protecting public safety, or conducting forensic analysis after a biological incident.  This section requires that the database be made available to relevant federal, State, and local officials. Biosecurity best practices shall be disseminated to registered laboratories and facilities.

11. Sect. 104: Background Checks This section authorizes the Attorney General to consult with the DHS Secretary in considering whether individuals having or applying for access to selected pathogens should be restricted because they have knowing involvement with a terrorist organization.

12. Sect. 105: Biological Laboratory Protection  This section will authorize the DHS Secretary to award grants for each fiscal year 2010-2012 to academic and nonprofit organizations to improve security at laboratories that handle Tier I pathogens.  The Standard will authorize DHS to encourage Select Agent laboratories to undergo voluntary DHS vulnerability assessments.

13. With this brief overview, let’s now deliberate on what might be construed by this standard and how it may affect the research community!