Transcript NYS DOH BioDefense Laboratory

Select Agents and
Associated Biosafety and
Biosecurity Considerations
Nick Cirino, PhD
Wadsworth Center, NYSDOH
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Biodefense
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Wadsworth Center
New York State Department of Health
Topics
• Lab Biosafety
– The Select Agent rule: Implications for
laboratories
• Biosecurity
– The USA PATRIOT act: Giving teeth to
the Select Agent rule.
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• Chain of custody
• Bringing it all together…
Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
Biosafety
Biosafety- reduce or eliminate accidental release of or
exposure to potentially hazardous agents
• Personnel safety
– Training and proficiency
– Continuing Education
– Vaccinations
• Institutional Safety
– Perception vs actual risk
– Liability, registrations, documentation
• Agent safety
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– Containment and Documentation
– Decontamination
Wadsworth Center
New York State Department of Health
Chain of Infection
Pathogen reservoir/stock
Portal of Escape
Practices / Equipment
Transmission
PPE
Route of Entry/infectious Dose
Immunization
Susceptible host
Surveillance
Incubation Period
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Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
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Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
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Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
Ongoing Education
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Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
Antiterrorism and Effective
Death Penalty Act of 1996
The Secretary of HHS shall, through regulation:
• Maintain a list of biological agents that have the potential
to pose a severe threat to public health and safety.
• Establish procedures for the transfer of the listed
biological agents, including measures to ensure:
– Proper training and appropriate skills to handle agents.
– Proper laboratory facilities to contain and dispose of agents.
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Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
Title 42 Part 72.6
“The Select Agent Rule”
Effective date: April 15, 1997
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www.cdc.gov/od/sap/addres.htm
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New York State Department of Health
The Select Agent Rule
Fundamental Components
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• A list of biological agents (“Select Agents”)
• Registration of facilities transferring these
agents
• Transfer requirements
• Verification procedures
• Agent disposal requirements
• Research and clinical exemptions
Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
Restricted Use of
Select Agents and Toxins
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• Any micro-organism, virus, infectious
substance, or biological product that may be
engineered as a result of biotechnology, or
[derivatives] of any such microorganism,
virus, [etc], capable of causing death,
disease, or other biological malfunction in a
human, an animal, a plant, or another living
organism; deterioration of food, water,
equipment, supplies, or material of any kind;
or deleterious alteration of the environment.
Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
Restricted Use of
Select Agents and Toxins
• The term "biological agent" DOES NOT
encompass any biological agent that is in its
naturally occurring environment, if the
biological agent has not been cultivated,
collected, or otherwise extracted from its
natural source.
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Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
Public Health Security and
Bioterrorism Preparedness and
Response Act
Signed: June 12, 2002
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• Significantly changed/replaced the regulatory authorities
of HHS under Sec. 511 of the “Antiterrorism and
Effective Death Penalty Act of 1996”.
• Granted comparable regulatory authorities to
USDA/APHIS for biological agents and toxins that
present a severe threat to plant or animal health, or
animal or plant products.
• Required coordination between USDA and HHS on
“overlap” agents regulated by both agencies.
Wadsworth Center
New York State Department of Health
Registration Exemptions
Clinical or Diagnostic Laboratories
Agents used only for diagnosis, verification, or
proficiency testing (no reference or retention allowed)
Transferred or destroyed after identification
Notify federal and state authorities
Products approved under a Federal Act
Investigational products (must apply for exemption)
Public health or agricultural emergency (must
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Biodefense
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apply for exemption)
Wadsworth Center
New York State Department of Health
Public Health Security and Bioterrorism
Preparedness and Response Act of 2002
OR
42 CFR Part 73 (effective date 03.18.05)
• Registration for Possession, Use, and Transfer
• Safety and Security Requirements
• Database Check by DOJ
• Entity and individual
• Restricted Persons (USA PATRIOT Act)
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Narrows Exemptions
Nondisclosure protection of sensitive information
Additional Criminal Penalties
Immediate Notification of Possession
Wadsworth Center
New York State Department of Health
42 CFR Part 73 (cont)
Biosafety
• List of Select Agents and Toxins (HHS and
Overlap)
– Updates list of select agents and toxins
– Regulates toxins based on potency and quantity
– Updates Genetic Elements, Recombinant Nucleic
Acids, and Recombinant Organisms
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• Must drill safety, security, and emergency
response annually.
Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
Biosecurity
Biosecurity- protect against theft or diversion of select agents
Control and documentation of materials and information
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Conduct risk assessments and address gaps
Implement Chain of Custody for S.A.
Implement a S.A. inventory control system
Develop COOP & IEMP
Perform personnel evaluations
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Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
Site-Specific Risk
Assessment
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Physical security
Data and electronic technology systems
Employee security
Access controls to laboratory & animal areas
Procedures for agent inventory and accountability
Shipping/transfer and receiving of select agents
Unintended incident and injury policies
Emergency response plans
Policies to address breaches in security
Wadsworth Center
New York State Department of Health
Security
Recommendations
• Establish a facility security plan
• Establish security-related policies for all
personnel
• Control access to areas where select agents
are used or stored
• Establish a system of accountability for select
agents
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Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
Chain of Events
Event/Release
Chain-of-Custody
Field Screens
Evidence Gathering
Transport to Laboratory
Lab Testing
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Biodefense
Laboratory
Lab
Reporting
Wadsworth Center
New York State Department of Health
Chain of Custody
• Intent- Maintain integrity of evidence which may be
used for prosecution.
• Implementation- DOCUMENTATION that evidence
could not have been compromised during
collection, transport, processing, analysis, storage,
or final disposition.
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Ensure physical security of evidence
Identify secure area for evidence storage
Limit personnel with access
Maintain access “Log Book”
• Full Consequences- *If you are the “custodian” of
the evidence, you must be able to testify to the
security of the evidence at all times!
Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
Security
Recommendations
• Develop procedures for transferring or
shipping select agents from the
laboratory (IATA, DOT)
• Implement an Institutional Emergency
Management Plan
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• Establish a protocol for reporting
adverse incidents
Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
Evidence Handling
Laboratory Practices
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Routine monitoring for contamination
Dedicated work space (if possible)
Work on only 1 item at a time
Change outer gloves between each
sample
• Use positive controls in separate area
• Secure in locked evidence container with
limited access
Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
Security Issues
Know your Workers
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• Depending on the agents involved, background
checks &/or security clearances should be done
before workers are given access w/o escort.
• Provide appropriate training & establish
proficiency before issuing access authority.
• All workers should wear photo ID badges with
name & expiration date.
• Consider color coding to indicate clearance to
enter restricted areas.
• Guests should be issued time-restrictive Visitor ID
badges & be escorted by workers at all times.
Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
Security Issues
Accountability
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Know what you have (inventory).
Know where it is.
Know who has access to it.
Know who gets it.
Know when it is destroyed or transferred.
“Knowing” means a written record.
Wadsworth Center
New York State Department of Health
42 CFR Part 73
Biosecurity
• APHIS and CDC immediate notification list
• Defines ‘access’ as possession, i.e., ability
to carry, use or manipulate, the SA or
Toxin.
• No notification necessary after
consumption or destruction after transfer.
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Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
Restricted Persons
• Are you under indictment for a crime punishable
by imprisonment for a term exceeding 1 year?
• Have you been convicted in any court or
received deferred adjudication for a crime
punishable by imprisonment for a term
exceeding 1 year?
• Are you a fugitive from justice?
• Do you unlawfully use any controlled substance
(as defined by § 102 of the Controlled
Substances Act (21 U.S.C. § 802))?
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Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
Restricted Persons (cont)
• Are you a citizen or permanent resident of the
United States? (CANT be national of Iran, Iraq, Syria,
Libya, Cuba, N. Korea, Sudan)
• Are you illegally or unlawfully in the United
States?
• Have you ever been adjudicated as a mental
defective or been committed to any mental
institution?
• Were you dishonorably discharged from the
Armed Services of the United States?
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Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
Making Biosafety and
Biosecurity a Priority
• The USA Patriot Act
• Institutional Safety Culture
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Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
USA PATRIOT Act
Uniting and Strengthening America by Providing
Appropriate Tools Required to Intercept and
Obstruct Terrorism
Signed: 10/26/2001
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• Restricted Use: (Section 817) Possession of
biological agents, toxins, or delivery systems in
quantity or of a type that is not reasonably justified
by a prophylactic, protective, bona fide research,
or other peaceful purpose.
• Restricted Persons: (Section 175b) Risk of
illegitimate use.
• Violations: Allows imprisonment of up to 10 years.
Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
“Application for Lab Registration
for Possession Use, and Transfer
of Select Agents or Toxins” Form:
APHIS/CDC Form 1
(the forms previously known as CDC
Form 0.1318 or APHIS Form 2040)
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Biodefense
Laboratory
Wadsworth Center
New York State Department of Health
“The world is a dangerous place to live, not just
because of the people who are evil, but because
of the people who don’t do anything about it.”
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- Albert Einstein
Wadsworth Center
New York State Department of Health