New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Select Agents and Associated Biosafety and Biosecurity Considerations Nick Cirino, PhD Wadsworth Center, NYSDOH

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Topics Lab BiosafetyLab Biosafety –The Select Agent rule: Implications for laboratories BiosecurityBiosecurity –The USA PATRIOT act: Giving teeth to the Select Agent rule. Chain of custodyChain of custody Bringing it all together…Bringing it all together…

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Biosafety Biosafety- reduce or eliminate accidental release of or exposure to potentially hazardous agents Personnel safetyPersonnel safety –Training and proficiency –Continuing Education –Vaccinations Institutional SafetyInstitutional Safety –Perception vs actual risk –Liability, registrations, documentation Agent safetyAgent safety –Containment and Documentation –Decontamination

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Chain of Infection Pathogen reservoir/stock Portal of Escape Transmission Route of Entry/infectious Dose Susceptible host Incubation Period Risk Assessment Practices / Equipment PPE Immunization Surveillance

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Ongoing Education

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H 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.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: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:

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Title 42 Part 72.6 “The Select Agent Rule” Effective date: April 15,

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H 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 The Select Agent Rule

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Restricted Use of Select 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 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.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.

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H 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.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.

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Public Health Security and Bioterrorism Preparedness and Response Act Signed: June 12, 2002 Significantly changed/replaced the regulatory authorities of HHS under Sec. 511 of the “Antiterrorism and Effective Death Penalty Act of 1996”.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.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.Required coordination between USDA and HHS on “overlap” agents regulated by both agencies.

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H 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) Registration Exemptions

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Registration for Possession, Use, and TransferRegistration for Possession, Use, and Transfer Safety and Security RequirementsSafety and Security Requirements Database Check by DOJ Database Check by DOJ Entity and individualEntity and individual Restricted Persons (USA PATRIOT Act)Restricted Persons (USA PATRIOT Act) Narrows ExemptionsNarrows Exemptions Nondisclosure protection of sensitive informationNondisclosure protection of sensitive information Additional Criminal PenaltiesAdditional Criminal Penalties Immediate Notification of PossessionImmediate Notification of Possession Public Health Security and Bioterrorism Preparedness and Response Act of 2002 OR 42 CFR Part 73 (effective date )

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H List of Select Agents and Toxins (HHS and Overlap)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.Must drill safety, security, and emergency response annually. 42 CFR Part 73 (cont) Biosafety 42 CFR Part 73 (cont) Biosafety

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Biosecurity Biosecurity- protect against theft or diversion of select agents Control and documentation of materials and information Conduct risk assessments and address gapsConduct risk assessments and address gaps Implement Chain of Custody for S.A.Implement Chain of Custody for S.A. Implement a S.A. inventory control systemImplement a S.A. inventory control system Develop COOP & IEMPDevelop COOP & IEMP Perform personnel evaluationsPerform personnel evaluations

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Site-Specific Risk Assessment Physical securityPhysical security Data and electronic technology systemsData and electronic technology systems Employee securityEmployee security Access controls to laboratory & animal areasAccess controls to laboratory & animal areas Procedures for agent inventory and accountabilityProcedures for agent inventory and accountability Shipping/transfer and receiving of select agentsShipping/transfer and receiving of select agents Unintended incident and injury policiesUnintended incident and injury policies Emergency response plansEmergency response plans Policies to address breaches in securityPolicies to address breaches in security

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Establish a facility security planEstablish a facility security plan Establish security-related policies for all personnelEstablish security-related policies for all personnel Control access to areas where select agents are used or storedControl access to areas where select agents are used or stored Establish a system of accountability for select agentsEstablish a system of accountability for select agents Security Recommendations

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Chain of Events Event/Release Evidence Gathering Transport to Laboratory Lab Reporting Lab Reporting Lab Testing Field Screens Chain-of-Custody

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Chain of Custody Intent- Maintain integrity of evidence which may be used for prosecution.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.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-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!

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Develop procedures for transferring or shipping select agents from the laboratory (IATA, DOT)Develop procedures for transferring or shipping select agents from the laboratory (IATA, DOT) Implement an Institutional Emergency Management PlanImplement an Institutional Emergency Management Plan Establish a protocol for reporting adverse incidentsEstablish a protocol for reporting adverse incidents Security Recommendations

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Routine monitoring for contaminationRoutine monitoring for contamination Dedicated work space (if possible)Dedicated work space (if possible) Work on only 1 item at a timeWork on only 1 item at a time Change outer gloves between each sampleChange outer gloves between each sample Use positive controls in separate areaUse positive controls in separate area Secure in locked evidence container with limited accessSecure in locked evidence container with limited access Evidence Handling Laboratory Practices

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Depending on the agents involved, background checks &/or security clearances should be done before workers are given access w/o escort.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.Provide appropriate training & establish proficiency before issuing access authority. All workers should wear photo ID badges with name & expiration date.All workers should wear photo ID badges with name & expiration date. Consider color coding to indicate clearance to enter restricted areas.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.Guests should be issued time-restrictive Visitor ID badges & be escorted by workers at all times. Security Issues Know your Workers

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Know what you have (inventory).Know what you have (inventory). Know where it is.Know where it is. Know who has access to it.Know who has access to it. Know who gets it.Know who gets it. Know when it is destroyed or transferred.Know when it is destroyed or transferred. “Knowing” means a written record.“Knowing” means a written record. Security Issues Accountability

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H APHIS and CDC immediate notification listAPHIS and CDC immediate notification list Defines ‘access’ as possession, i.e., ability to carry, use or manipulate, the SA or Toxin.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.No notification necessary after consumption or destruction after transfer. 42 CFR Part 73 Biosecurity

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Restricted Persons Are you under indictment for a crime punishable by imprisonment for a term exceeding 1 year?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?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?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))?Do you unlawfully use any controlled substance (as defined by § 102 of the Controlled Substances Act (21 U.S.C. § 802))?

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H 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 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?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?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?Were you dishonorably discharged from the Armed Services of the United States? Restricted Persons (cont)

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Making Biosafety and Biosecurity a Priority The USA Patriot ActThe USA Patriot Act Institutional Safety CultureInstitutional Safety Culture

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H USA PATRIOT Act Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Signed: 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 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.Restricted Persons: (Section 175b) Risk of illegitimate use. Violations: Allows imprisonment of up to 10 years.Violations: Allows imprisonment of up to 10 years.

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H “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 or APHIS Form 2040)

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H “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