Executive Order Working Group on Strengthening the

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 hospitals
  (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, painters 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 Nations 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

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Proliferation of High Containment Facilities
Level 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

5
Known Statistics of High Containment Facilities
Level 3

• 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)

GAO Report 08-108T Working Group on Physical
and Facility Security
6
Known Statistics of BSAT Labs Level 2

• 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.

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.

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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

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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

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5 Working Groups on the Task Force

• Oversight and Inspection Standard
• Personnel Security Reliability
• Physical and Security Facility
• Select Agent Rule
• Transportation

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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

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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)

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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

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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

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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

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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.

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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
  Enforcements 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)

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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?

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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

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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.