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Possession, Use, and Transfer of Select Agents and Toxins

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Hoaxes. SA Registration. Appointment of RO, ARO's. Control of access to Select Agents ... Background check (FBI clearance) restricted person criteria ... – PowerPoint PPT presentation

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Title: 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 1 year
  • has been convicted of crime punishable by
    imprisonment 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 Inspections Advanced 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?
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