Executive Order Working Group on Strengthening the Biosecurity of the United States

1. Executive Order Working Group on Strengthening the Biosecurity of the United States Diane J. Rodi Biosciences Division Argonne National Laboratory Member of sub-working groups: Transportation Oversight and Inspections

2. Task Force Chronology Recent laboratory incidents, biocrimes and bioterrorism events such as: 1984: Followers of Bhagwan Shree Rajneesh produce 751 cases of Salmonella by seeding 10 salad bars in The Dalles, Oregon 1996: Lab technician Diane Thompson removed Shigella dysentariae Type 2 from her hospital�s (Dallas, Texas) collection and infected co-worker by contaminating pastries in the office breakroom; 12 people became ill 2001: post 9/11-anthrax mail attacks; subsequent suicide of suspect and USAMRIID employee Bruce Ivins 2004-2005: LAIs at Boston University-Tularemia 2006-2007: LAIs at Texas A & M- Brucella 2007: Foot and Mouth Disease outbreak at Pirbright in Surrey, UK (cost to date in the hundreds of millions of �s) 2008: Las Vegas ricin incident- Roger Von Bergendorff, after having been taken to a hospital from a motel room and placed on life support, was found by police and FBI to have ricin, castor beans, syringes, and beakers in the room. Follow-up FBI searches uncovered castor beans, various chemicals used in the production of ricin, a respirator, filters, painter�s mask, laboratory glassware, syringes, and a notebook on ricin production in a storage unit nearby.

3. Congressional and Public Interest in BSL-3 and BSL-4 Laboratories House Energy and Commerce Subcommittee on Oversight and Investigations hearing entitled Germs, Viruses, and Secrets: The Silent Proliferation of Biolaboratories in the United States. October 4, 2008 (Dingell hearing). GAO report, High-Containment Biosafety Laboratories, Preliminary Observation on the Oversight of the Proliferation of BSL-3 and BSL-4 Laboratories in the United States. 2007. GAO-08-108T GAO report, Biosafety Laboratories: Perimeter Security Assessment of the Nation�s Five BSL-4 Laboratories. 2008. GAO-08-1092 World at Risk: The Report of the Commission on the Prevention of WMD Proliferation and Terrorism. Released December 2, 2008

4. Biosafety Level-4 Laboratories: Operational 5 Center for Biodefense and Emerging Infectious Diseases, Galveston, TX Center for Biotechnology and Drug Design, Georgia State University, Atlanta, GA Division of Consolidated Laboratory Services, Richmond, VA Southwest Foundation for Biomedical Research, San Antonio, TX Dale and Betty Bumpers Vaccine Research Center, N.I.A.I.D., Bethesda, MD Biosafety Level-4 Laboratories: Expanding 2 CDC Special Pathogens Branch, Atlanta, GA USAMRIID, DOD, Frederick, MD Biosafety Level-4 Laboratories: Planned 5 Ft. Detrick Integrated Research Facility, NIAID, Frederick, MD Galveston National Laboratory, UTMB, Galveston, TX National Biodefense Analysis and Countermeasures Center, DHS, Frederick, MD National Emerging Infectious Diseases Laboratory, Boston University, Boston, MA Rocky Mountain Laboratories Integrated Research Facility, NIAID, Hamilton, MT Proliferation of High Containment Facilities Level 4

5. 2/3 of BSAT labs are outside the federal sector* At least 46 states have at least one state public health BSL3 lab (over 140 total)* Total of 324 BSAT-registered entities with CDC& As of April 2008, approvals for BSAT work, including supervisors and support personnel � everyone who has even limited access to BSAT: 9,918 people approved by CDC (DHHS), 4,336 by APHIS (USDA) & Since program inception: 28,593 total processed 158 disapproved: 51 appealed (30 sustained, 21 overturned) & Known Statistics of High Containment Facilities Level 3

6. Currently are 35 entities that perform USDA select agent work in a BSL-2/ABSL-2 environment involving 193 laboratories in various settings, i.e. academic, federal, state, and commercial. Entities registered with HHS currently have 187 entities that perform select agent and toxin work in a BSL-2/ABSL-2/BSL-2 like environments involving 598 laboratories in various settings, i.e. academic, federal, state, and commercial. Essentially 55% of the USDA-registered entities that work with select agents have a BSL-2 laboratory component. 57% of the HHS-registered entities that work with select agents and toxins have a BSL-2 laboratory component. Known Statistics of BSAT Labs Level 2

7. Estimated BSL3/4 Facilities* *The GAO Report stated that: ��no one agency knows the number and location of these labs in the United States.�

8. Federal Task force on Biosecurity Led to January 9, 2009: Executive Order 13486 �Strengthening the Biosecurity of the United States� Co-chaired by HHS and DOD with participation from Federal Departments/Agencies Scope of Activity Federal and nonfederal facilities that conduct research on, manage clinical or environmental laboratory operations involving, or handle, store, or transport biological select agents and toxins Physical/facility, and personnel security

9. Assigned Tasks Review, evaluate, and report on efficiency and effectiveness of existing laws, regulations, guidance, and practices relating to physical/facility, and personnel security and assurance at Federal and nonfederal facilities Prepare a written report to the President 180 days after EO (July 9, 2009) that: summarizes the present state of affairs (existing laws, regulations, guidance, and practices); Provides a comparison of the range of existing personnel security and assurance programs for access to biological select agents and toxins to similar programs in other fields and industries; Makes recommendations for any new legislation, regulations, guidance, or practices; Includes options for establishing oversight mechanisms to ensure a baseline standard is consistently applied

10. Oversight and Inspection Standard Personnel Security & Reliability Physical and Security Facility Select Agent Rule Transportation 5 Working Groups on the Task Force

11. Task Force Timeline April 8*: Full WG discussion of laws, regulations, and guidelines and initiate gap analyses Finalize report outline Finalize lab site visit plan and initiate laboratory site visits April 22* Sub-WG preliminary reports on gap analyses of topic areas Initiate development of sub-WG recommendations for any new legislation, regulations, guidance, or practices for security and personnel assurance for all Federal and nonfederal facilities Develop draft options for establishing oversight mechanisms April 29 Sub-WG final reports on gap analyses of topic areas May 6* Review of sub-WG recommendations, comparison of the range of existing personnel security and assurance programs and options for establishing oversight mechanisms by full WG May 13-14* Public/Scientific Consultation on Laboratory Biosecurity and Personnel Assurance May 27* Complete lab site visits Development of recommendations and options by full WG June 10* Final draft report due for WG review June 24* Compete review of draft report by full WG July 8* Complete draft report July 9 Submit report to the President, through the Co-chairs

12. Stages of Analysis and Recommendations Analysis of current regulations and guidelines and the degree of consistency for both Federal Agency and Academic laboratories (done) Gap Analysis for all five topic areas (4/29) Develop draft options/recommendations to eliminate gaps (5/27) Public/Scientific discussions (5/13-14) Draft report to full Working Group (6/10) Submit final report to the President (7/09)

13. Current Global Regulations and Guidelines Current regulations include: BSAT (Possession and Movement of Select Agents and Toxins) DOT (Transportation of All Etiologic Agents) CDC/USDA (Import into the U.S.) DOC Bureau of Export Administration (Export to other countries) USDA/APHIS (Permits for Possession and Movement) Current Guidelines include: Biosafety in Microbiological and Biomedical Laboratories 5th edition NIH Guidelines on rDNA NSABB Policies on Dual-Use Research

14. Approach Sub-working groups are collecting data and developing matrices which demonstrate the degree of harmonization (or lack thereof) of federal efforts to secure BSATs Issues analyzed include registration of agents/toxins; training; personnel security and assurance; physical security; transportation; oversight and inspection; inventory and accountability Each area given a harmonization score to lead downstream discussions

15. Strawman Draft Recommendationsfor Physical and Facility Group Require the use of a standard risk assessment methodology to be used by all BSAT facilities to guide a tiered approach to physical security design. Focus physical security requirements on pre-specified criteria for Threat-Stratification of Agents and Toxins, not on Biosafety Levels. Develop prescriptive baseline physical security requirements for each of the stratification tiers

16. Oversight and Inspections gap considerations under discussion Lack of coordination between inspection/oversight groups The entity cost of hosting multiple, overlapping site visits Different interpretations/standards between different inspection groups Performance-based versus prescriptive inspection criteria

17. Strawman Draft Recommendationsfor Oversight and Inspection Establish a USG coordinating ?ber-entity staffed by detailees from various stakeholder agencies to facilitate information sharing on and coordination of regulations, policies, and inspection schedules/activities. At present the GAO found that there are 15 federal agencies with some connection to BSL3/4 labs:

18. Strawman Draft Recommendationsfor Oversight and Inspections Develop coordinated training and oversight programs for inspectors from various USG agencies and offices with oversight responsibilities. Provide comprehensive guidance on inventory management and recordkeeping requirements, approaches and templates. Require entities to submit detailed facility-specific inventory management plans as part of the registration (renewal) process.

19. Transportation gap considerationsunder discussion Accountability of the select agent and toxin while in transit. Couriers not Security Risk Assessment-approved. Transportation security and incident response plans for select agents and toxins. First responders in the event a transit loss of a select agent or toxin.

20. Strawman Draft Recommendationsfor Transportation CDC and APHIS should consider further stratification of BSATs to identify those that pose the greatest security risks. Require TSA to conduct an assessment of the security risks posed by the transportation of specific SATs with a view towards determining appropriate security controls to address the identified risks.

21. Strawman Draft Recommendationsfor Transportation Consider developing a system/requirements for communication between entities, couriers, DOT, CDC/USDA for instance through a secure web portal. Consider requiring shippers and carriers of SATs to be registered. DOT, CDC, and USDA should ensure that information on SAT shippers and carriers is protected from disclosure that could compromise security. Consider modifying the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) and the HMR and international transport regulations (e.g. ICAO TI, IMDG Code) so that the technical name of the pathogen is not required on shipping papers.

22. Personnel Security and Reliabilitygap considerations under discussion Need to develop a standardized Personnel Reliability Program for BSAT labs, but based upon what criteria? Current BSAT Security Risk Assessment requires: self-declaration of criminal record, mental health history and illegal drug use; FBI check of criminal databases as well as prohibited categories, which include individuals convicted of terrorist activities or who have knowing involvement with terrorist organization; update every 5 years.

23. Federal databases that are searched for the Security Risk Assessment conducted under the Select Agent Program National Crime Information Center (NCIC) Files: Foreign Fugitive File, Deported Felon File , Protection Order File Wanted Person File , U.S. Secret Service Protective File , SENTRY File (Bureau of Prisons) Convicted Person on Supervised Release File, Convicted Sexual Offender Registry , Violent Gang and Terrorist Organizations File ?? Interstate Identification Index: State/Local criminal history ?? Foreign Terrorist Tracking Task Force Terrorist Screening Center Database (TSDB) , Transportation Security Administration (TSA)�s No Fly and Selectee databases ?? Automated Case Support (ACS): FBI case file database ?? Bureau of Immigration and Customs Enforcement�s Law Enforcement Support Center databases (for foreign-born candidates) Central Index System (CIS) , Computer Linked Application Information Management System (CLAIMS) Deportable Alien Control System (DACS) , National Automated Immigration Lookout System (NAILS II) Nonimmigrant Information System (NIIS), Student and Exchange Visitor Information System (SEVIS) Redesigned Naturalization Application Casework System (RNACS) , Refugee, Asylum, and Parole System (RAPS) Enforcement Case Tracking System (ENFORCE) , Treasury Enforcement Communications System (TECS)

24. Personnel Security and Reliabilitygap considerations under discussion A comprehensive PRP requires: background check akin to those required for a security clearance; polygraph exam; Initial and random drug/alcohol tests; Mental health evaluation by psychiatrist and medical examination/records review by CMA; Monitoring by supervisors; Peer reporting; Periodic re-evaluations (potentially daily self-reporting of medications or changes in health status) How far to go between the two?

25. NSABB Meeting 4/29/2009live webcast Reviewed draft report available on web site 5 elements: Yes to enhanced personnel reliability measures but no to formal national PRP Yes to strengthening the current SRA process Yes to enhancing the culture of responsibility and accountability via education and outreach Yes to further work by professional societies to maintain vigilance about biosecurity issues List of BSATs should be reduced or stratified

26. Public Consultation MeetingMay 13-14, 2009 At Hyatt Regency Bethesda Purpose is to obtain feedback from the community on a long list of issues Each working group will have panels of experts to moderate discussion i.e. rep from FedEx for Transport group, etc.