Possession, Use, and Transfer of Select Agents and Toxins

1
Possession, Use, and Transfer of Select Agents
and Toxins
2
Biowarfare/Bioterrorism

• Geneva Protocol (1925)
• Biological Weapons Convention (1972)
• Biological Weapons Act (1989)
• Public Law 101-298
• Chemical and Biological Weapons Control and
  Warfare Elimination Act of 1991
• Public Law 102-182

3
Select Biological Agents/Toxins

• Anti-terrorism and Effective Death Penalty Act of
  1996 (Public Law 104-132)
• Additional Requirements for Facilities
  Transferring or Receiving Select Agents
  42 CFR Part 72.6 (Select Agent Rule)
• USA Patriot Act (Public Law 107-56
• Uniting and Strengthening America by Providing
  Appropriate Tools Required to Intercept and
  Obstruct Terrorism Act of 2001
• Possession now addressed

4
DHHS-CDC, USDA-APHIS

• Public Health Security and Bioterrorism
  Preparedness Response Act of 2002
• Public Law 107-188
• 42 CFR Part 73, 9 CFR Part 121, 7 CFR Part 331
• Regulatory language for USA PATRIOT ACT
• Lists of Select Agents

5
Anthrax Letters - Fall 2001

• 5 deaths (FL, NJ, NY, CT)
• 22 total infections
• Mass terror
• White powder fever!
• Unsolved crime

6
Other bioterror events

• Salmonella in salad bars
• Shigella in pastries
• 125-I Saxitoxin in take-out food
• Ricin at IRS building -thwarted before use
• UCONN anthrax
• Texas Tech
• lost Yersinia samples
• Hoaxes

7
SA Registration

• Appointment of RO, AROs
• Control of access to Select Agents
• Guidance sought from multiple sources
• calls to federal agencies
• Health Physics
• Emergency responders (local, regional)

8
Registration

• Access control
• PI and only those with access to agents
• Lock-down philosophy
• Agents locked at all times when not in use
• lock boxes, locked freezers, double padlocks for
  storage
• locked incubators
• locked animal storage units
• locked doors, keycard access

9
Restricted Access

• Police, Fire personnel not included
• In event of fire, alarm, emergency
• C - A - L - L System employed
• C - Cover
• A - Abandon work
• L - Lock agent away
• L - Leave the laboratory

10
USA PATRIOT ACT

• Restricted person (cant possess, receive,
  transport)
• under indictment for a crime punishable by
  imprisonment for a term gt 1 year
• has been convicted of crime punishable by
  imprisonment gt 1 year
• fugitive from justice
• unlawful user of a controlled substance
• illegal alien
• adjudicated as a mental defective
• dishonorable discharge from US Armed Services

11
Restricted Person

• Is an alien who is a national from a country that
  has history of supporting terrorism
• Syria
• Sudan
• Lybia
• Cuba
• Iran
• Iraq
• North Korea

12
73.11 Security
Plan

• Written Plan
• Individual clearance
• Training
• Inventory control Record Keeping
• Physical Security
• Visitor Access Policies
• Cyber Security
• Notification and Reporting
• suspicious events
• compromised security
• exposures, releases

13
Authorized individuals

• DOJ registered entity personnel
• Background check (FBI clearance)
• restricted person criteria
• Have direct access to Select Agents (SAs)
• Biohazard (BL3) clearance

14
Authorized individuals

• Notify
• updates in lab staff (new, exiting staff)
• disgruntled employees in lab (those authorized or
  with access to SA areas)
• Suspicious behaviour
• restrict access/change locks

15
Inventory

• Baseline Tracking Form established for each lab
• Agent, source, qty, use, destruction
• Checked periodically by ROs
• quarterly check of inventory, people, security
• Posters
• Security
• Toxins (working safely, includes exempt quantity
  limits)

16
SA Inventories
(Log/checkbook)

• For each SA
• Agent name, characteristics, source data
• qty held on date of 1st inventory
• qty acquired, source, date of acquisition
• qty, volume or mass destroyed, and date of each
  action
• qty used, date of use (toxins only)
• qty transferred, transfer date, individuals
  involved
• current qty held
• Any SA lost, stolen, or unaccounted for
• Written explanation of any discrepancies
• Records maintained by PI and RO

17
Inventory Security

• Unscheduled checks of security
• (merge with other efforts)
• after hours attempt to gain access to area,
  freezer, and lock box
• Lapses immediately reported to lab group
• Corrections and more frequent checks for groups
  found not in compliance.

18
Security Training For Select Agent Laboratories

• Applicable Regulations
• 42 CFR Part 73 (DHHS)
• 9 CFR 121 (APHIS)
• 7 CFR 331 (APHIS)

19
Security Training

• Individual training for each group
• Select Agent Security Poster
• Signed select agent security statement
• Protection of inventory, records
• Responsibility for restricting access
• Immediate notification of loss, theft, inventory
  discrepancy, other

20
Physical Security

• Intrusion alarms
• glass break
• motion sensors
• dead latch
• hinged pins
• High priority response areas
• Security Police

21
Physical Security

• Lock boxes
• Locked freezers, incubators, animal cages, etc.
• Locked Door
• keycard access
• each entry/exit recorded

22
Cyber Security

• Cyber Security Office
• Firewalls
• Passwords
• Locked computer stations
• Anti-virus programs
• Prudent exchange of information

23
Visitor Access Policy to SA areas

• Notify RO before bringing in guests
• Training prior to entry
• Escorted at all times in SA areas
• Service work cleared before escorted entry
• Record of entry/exit and escort name

24
Notification
Reporting

• Suspicious
• people
• activity
• packages (in or out)
• Immediately report to
• Police
• Local Security
• RO

25
Notification
Reporting

• Spills/releases
• Loss of keys/IDs
• Theft or missing SAs
• Alteration of record
• Immediately report to
• Police
• Local Security
• RO

26
Notification
Reporting

• All Transfers
• intra-facility
• inter-facility
• OEHS, DHHS, USDA approval
• EA-101 Form
• Destruction of SAs
• 5 day notification
• Await federal approval

27
Records (maintained for 3 years)

• For access to areas where SAs used/stored
• name of each person who has accessed area
• date/time of entry - date/time individual left
  area
• Records of all entries to space of non approved
  persons and the authorized users who accompanied
  them
• ROs inspection records of SA locations (at least
  annually), list of authorized workers
• Safety, security, emergency response plans
• Training, transfer records
• Safety, security incident reports

28
Notification of theft, loss, release

• Theft/loss of SA
• immediate notification to
• HHS Secretary (APHIS) by phone, fax, or email
• State law enforcement authorities
• Local law enforcement authorities
• reported whether recovered or not, or responsible
  parties identified
• Follow-up written report to HHS/APHIS w/in 7 days

29
Ongoing Efforts

• FBI fingerprinting
• Local Police
• Inspections
• Verify/Update people, inventories, locations
• Assist with registration of new PIs, agents,
  experiments
• Restricted personnel list updated as required by
  experience
• will look closely at emergencies

30
Penalties and Fines

• 73.19 Civil money
  penalites
• 250,00 - 500,000
• 73.20 Criminal Penalties
• 5 - 10 years in Prison

31
Select Agent InspectionsAdvanced Preparation
32
Opening Conference

• Confirm credentials
• Program Overview
• Lab entry reqs
• immunization, screening, PPE
• Review schedule
• document review, lab tour, agent check
• Visitor security safety training

33
Documentation Review

• Training
• clearances
• Written plans
• security, biosafety, emergency
• Inventories
• agent, access logs
• Inspections
• safety, security, facility, equipment
• Incidents

34
Suggested Documentation

• Lab inspection records
• security
• BL3
• Air balancing
• biosafety cabinets
• autoclaves
• Exhaust HEPA Filters
• Written Plans
• Security
• Biosafety
• BL3
• BBP
• Shipping/Transport

• Background check -
• FBI Clearance letter
• Training records
• biosafety
• BBP
• BL3
• BL3 Field Observation
• Security
• Chemical Safety

35
Suggested Documentation

• Posters
• Security
• C-A-L-L
• BL3 Spill Response
• Exposure Response
• Centrifuge Safety
• Lab Door Sign
• BSLevel, entry reqs
• Required PPE
• Approved protocols
• written SOPs

• Inventory
• Agent access logs
• inventory inspections
• Visitor access logs
• Incidents
• spills
• exposures
• alarms
• fire drills

36
Select Agent Lab Entry

• Visitor security safety training
• Accompanied by authorized person
• Record lab access
• PPE
• Restrict or check bags
• Offer paper/pens in lab fax notes out

37
Security Check

• Personnel
• Locked Facilities
• Lockable
• Freezers (2 locks)
• lock boxes
• incubators
• Agent access logs
• Intrusion prevention
• Written plan

38
Work Practice Observation

• Security practices
• Facility entry/exit
• Use/disposal of PPE
• Storage, transport
• Use of biosafety cabinet
• Decontamination
• Biowaste collection disposal

39
Closing Conference

• Findings summary
• Immediate concerns
• Onsite corrections?
• Report date?