Select Agents and Associated Biosafety and Biosecurity ConsiderationsNick Cirino, PhDWadsworth Center, NYSDOH
Topics • Lab Biosafety • The Select Agent rule: Implications for laboratories • Biosecurity • The USA PATRIOT act: Giving teeth to the Select Agent rule. • Chain of custody • Bringing it all together…
BiosafetyBiosafety- 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 • Containment and Documentation • Decontamination
Chain of Infection Pathogen reservoir/stock Portal of Escape Practices / Equipment Transmission PPE Route of Entry/infectious Dose Immunization Risk Assessment Susceptible host Surveillance Incubation Period
Antiterrorism and Effective Death Penalty Act of 1996 • 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. The Secretary of HHS shall, through regulation:
Title 42 Part 72.6 “The Select Agent Rule” Effective date: April 15, 1997 www.cdc.gov/od/sap/addres.htm
The Select Agent Rule • Fundamental Components • A list of biological agents (“Select Agents”) • Registration of facilities transferring these agents • Transfer requirements • Verification procedures • Agent disposal requirements • Research and clinical exemptions
Restricted Use ofSelect Agents and Toxins • 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 ahuman, 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.
Restricted Use ofSelect 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.
Public Health Security and Bioterrorism Preparedness and Response ActSigned: June 12, 2002 • 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.
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 apply for exemption)
Public Health Security and Bioterrorism Preparedness and Response Act of 2002OR42 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) • Narrows Exemptions • Nondisclosure protection of sensitive information • Additional Criminal Penalties • Immediate Notification of Possession
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 • Must drill safety, security, and emergency response annually.
BiosecurityBiosecurity- protect against theft or diversion of select agentsControl and documentation of materials and information • 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
Site-Specific Risk Assessment • 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
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
Chain-of-Custody Chain of Events Event/Release Field Screens Evidence Gathering Transport to Laboratory Lab Reporting Lab Testing
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. • 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!
Security Recommendations • Develop procedures for transferring or shipping select agents from the laboratory (IATA, DOT) • Implement an Institutional Emergency Management Plan • Establish a protocol for reporting adverse incidents
Evidence HandlingLaboratory Practices • 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
Security IssuesKnow your Workers • 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.
Security IssuesAccountability • 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.
42 CFR Part 73Biosecurity • 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.
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))?
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?
Making Biosafety and Biosecurity a Priority • The USA Patriot Act • Institutional Safety Culture
USA PATRIOT ActUniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct TerrorismSigned: 10/26/2001 • 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.
“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)
“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.” - Albert Einstein