New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Select Agents and Associated Biosafety and Biosecurity Considerations.

New York State Department of HealthWadsworth CenterBiodefense Biodefense

LaboratoryLaboratory

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Select Agents and Select Agents and Associated Biosafety and Associated Biosafety and

Biosecurity Biosecurity ConsiderationsConsiderations

Nick Cirino, PhDNick Cirino, PhDWadsworth Center, Wadsworth Center,

NYSDOHNYSDOH



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TopicsTopics

• Lab BiosafetyLab Biosafety– The Select Agent rule: Implications for The Select Agent rule: Implications for

laboratorieslaboratories

• BiosecurityBiosecurity– The USA PATRIOT act: Giving teeth to the The USA PATRIOT act: Giving teeth to the

Select Agent rule.Select Agent rule.

• Chain of custodyChain of custody

• Bringing it all together…Bringing it all together…



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BiosafetyBiosafety Biosafety- reduce or eliminate accidental Biosafety- reduce or eliminate accidental

release of or exposure to potentially hazardous release of or exposure to potentially hazardous agentsagents

• Personnel safetyPersonnel safety– Training and proficiencyTraining and proficiency– Continuing EducationContinuing Education– VaccinationsVaccinations

• Institutional SafetyInstitutional Safety– Perception vs actual riskPerception vs actual risk– Liability, registrations, documentationLiability, registrations, documentation

• Agent safetyAgent safety– Containment and DocumentationContainment and Documentation– DecontaminationDecontamination



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Chain of InfectionChain of Infection

Pathogen reservoir/stockPathogen reservoir/stock

Portal of EscapePortal of Escape

TransmissionTransmission

Route of Entry/infectious DoseRoute of Entry/infectious Dose

Susceptible hostSusceptible host

Incubation PeriodIncubation Period

Risk A

ssessment

Risk A

ssessment

Practices / EquipmentPractices / Equipment

PPEPPE

ImmunizationImmunization

SurveillanceSurveillance



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Ongoing EducationOngoing Education



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Antiterrorism and Antiterrorism and Effective Death Penalty Effective Death Penalty

Act of 1996 Act of 1996

• Maintain a list of biological agents that have the potential Maintain a list of biological agents that have the potential to pose a severe threat to public health and safety.to pose a severe threat to public health and safety.

• Establish procedures for the transfer of the listed Establish procedures for the transfer of the listed biological agents, including measures to ensure:biological agents, including measures to ensure:– Proper training and appropriate skills to handle agents.Proper training and appropriate skills to handle agents.– Proper laboratory facilities to contain and dispose of agents.Proper laboratory facilities to contain and dispose of agents.

The Secretary of HHS shall, through regulation:



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Title 42 Part 72.6

“The Select Agent Rule”Effective date: April 15, 1997

www.cdc.gov/od/sap/addres.htm



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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



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Restricted Use ofRestricted Use ofSelect Agents and Select Agents and

ToxinsToxins• Any micro-organismAny micro-organism, virus, infectious , virus, infectious substance, or biological product that may be substance, or biological product that may be engineered as a result of biotechnology, or engineered as a result of biotechnology, or [derivatives] of any such microorganism, [derivatives] of any such microorganism, virus, [etc], virus, [etc], capable of causing death, capable of causing death, diseasedisease, or other biological malfunction , or other biological malfunction in ain a human, an animal, a planthuman, an animal, a plant, or another living , or another living organism; deterioration of food, water, organism; deterioration of food, water, equipment, supplies, or material of any kind; equipment, supplies, or material of any kind; or deleterious alteration of the environment.or deleterious alteration of the environment.



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Restricted Use ofRestricted Use ofSelect Agents and ToxinsSelect Agents and Toxins

• The term "biological agent" DOES NOT The term "biological agent" DOES NOT encompass any biological agent that is in its encompass any biological agent that is in its naturally occurring environment, if the naturally occurring environment, if the biological agent has not been cultivated, biological agent has not been cultivated, collected, or otherwise extracted from its collected, or otherwise extracted from its natural source.natural source.



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Public Health Security and Public Health Security and Bioterrorism Preparedness Bioterrorism Preparedness

and Response Actand Response ActSigned: June 12, 2002Signed: June 12, 2002

• Significantly changed/replaced the regulatory authorities Significantly changed/replaced the regulatory authorities of HHS under Sec. 511 of the “Antiterrorism and of HHS under Sec. 511 of the “Antiterrorism and Effective Death Penalty Act of 1996”.Effective Death Penalty Act of 1996”.

• Granted comparable regulatory authorities to Granted comparable regulatory authorities to USDA/APHIS for biological agents and toxins that USDA/APHIS for biological agents and toxins that present a severe threat to plant or animal health, or present a severe threat to plant or animal health, or animal or plant products.animal or plant products.

• Required coordination between USDA and HHS on Required coordination between USDA and HHS on “overlap” agents regulated by both agencies.“overlap” agents regulated by both agencies.



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Clinical or Diagnostic LaboratoriesClinical or Diagnostic LaboratoriesAgents used only for diagnosis, verification, or Agents used only for diagnosis, verification, or

proficiency testing (no reference or retention allowed)proficiency testing (no reference or retention allowed)

Transferred or destroyed after identificationTransferred or destroyed after identification

Notify federal and state authoritiesNotify federal and state authorities

Products approved under a Federal ActProducts approved under a Federal Act

Investigational products Investigational products (must apply for exemption)(must apply for exemption)

Public health or agricultural emergency Public health or agricultural emergency (must (must apply for exemption)apply for exemption)

Registration Registration ExemptionsExemptions



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• Registration for Registration for PossessionPossession, Use, and Transfer, Use, and Transfer• Safety and Safety and SecuritySecurity Requirements Requirements• Database Check by DOJDatabase 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 Public Health Security and Bioterrorism Preparedness and Bioterrorism Preparedness and

Response Act of 2002Response Act of 2002OROR

42 CFR Part 73 42 CFR Part 73 (effective date (effective date

03.18.05)03.18.05)



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• List of Select Agents and Toxins (HHS and List of Select Agents and Toxins (HHS and Overlap)Overlap)– Updates list of select agents and toxinsUpdates list of select agents and toxins– Regulates toxins based on potency and quantity Regulates toxins based on potency and quantity – Updates Genetic Elements, Recombinant Nucleic Updates Genetic Elements, Recombinant Nucleic

Acids, and Recombinant OrganismsAcids, and Recombinant Organisms

• Must drill safety, security, and emergency Must drill safety, security, and emergency response annually.response annually.

42 CFR Part 73 42 CFR Part 73 (cont)(cont)

BiosafetyBiosafety



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BiosecurityBiosecurity Biosecurity- protect against theft or diversion of select Biosecurity- protect against theft or diversion of select

agentsagents

Control and Control and documentationdocumentation of materials and of materials and

informationinformation• 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



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Site-Specific Risk Site-Specific Risk AssessmentAssessment

• 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



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• Establish a facility security planEstablish a facility security plan• Establish security-related policies for all Establish security-related policies for all

personnelpersonnel• Control access to areas where select agents Control access to areas where select agents

are used or storedare used or stored• Establish a system of accountability for select Establish a system of accountability for select

agentsagents

Security Security RecommendationsRecommendations



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Chain of EventsChain of EventsEvent/ReleaseEvent/Release

Evidence GatheringEvidence Gathering

Transport to LaboratoryTransport to Laboratory

Lab Reporting

Lab ReportingLab TestingLab Testing

Field ScreensField ScreensChain-of-CustodyChain-of-Custody



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Chain of CustodyChain of Custody

• IntentIntent- Maintain integrity of evidence which may be - Maintain integrity of evidence which may be used for prosecution.used for prosecution.

• ImplementationImplementation- DOCUMENTATION that evidence - DOCUMENTATION that evidence could not have been compromised during collection, could not have been compromised during collection, transport, processing, analysis, storage, or final transport, processing, analysis, storage, or final disposition.disposition.– Ensure physical security of evidenceEnsure physical security of evidence– Identify secure area for evidence storageIdentify secure area for evidence storage– Limit personnel with accessLimit personnel with access– Maintain access “Log Book”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!



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• Develop procedures for transferring or Develop procedures for transferring or shipping select agents from the shipping select agents from the laboratory (IATA, DOT)laboratory (IATA, DOT)

• Implement an Institutional Emergency Implement an Institutional Emergency Management PlanManagement Plan

• Establish a protocol for reporting Establish a protocol for reporting adverse incidentsadverse incidents

Security Security RecommendationsRecommendations



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• 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 Change outer gloves between each samplesample

• Use positive controls in separate areaUse positive controls in separate area

• Secure in locked evidence container with Secure in locked evidence container with limited accesslimited access

Evidence HandlingEvidence HandlingLaboratory PracticesLaboratory Practices



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• Depending on the agents involved, background Depending on the agents involved, background checks &/or security clearances should be done checks &/or security clearances should be done before workers are given access w/o escort.before workers are given access w/o escort.

• Provide appropriate training & establish Provide appropriate training & establish proficiency before issuing access authority.proficiency before issuing access authority.

• All workers should wear photo ID badges with All workers should wear photo ID badges with name & expiration date.name & expiration date.

• Consider color coding to indicate clearance to Consider color coding to indicate clearance to enter restricted areas.enter restricted areas.

• Guests should be issued time-restrictive Visitor Guests should be issued time-restrictive Visitor ID badges & be escorted by workers at all times.ID badges & be escorted by workers at all times.

Security IssuesSecurity IssuesKnow your WorkersKnow your Workers



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• 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 IssuesSecurity IssuesAccountabilityAccountability



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• APHIS and CDC immediate notification listAPHIS and CDC immediate notification list

• Defines ‘access’ as possession, i.e., ability Defines ‘access’ as possession, i.e., ability to carry, use or manipulate, the SA or to carry, use or manipulate, the SA or Toxin.Toxin.

• No notification necessary after No notification necessary after consumption or destruction after transfer.consumption or destruction after transfer.

42 CFR Part 7342 CFR Part 73BiosecurityBiosecurity



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Restricted PersonsRestricted Persons

• Are you under indictment for a crime punishable Are you under indictment for a crime punishable by imprisonment for a term exceeding 1 year?by imprisonment for a term exceeding 1 year?

• Have you been convicted in any court or Have you been convicted in any court or received deferred adjudication for a crime received deferred adjudication for a crime punishable by imprisonment for a term punishable by imprisonment for a term exceeding 1 year?exceeding 1 year?

• Are you a fugitive from justice?Are you a fugitive from justice?• Do you unlawfully use any controlled substance Do you unlawfully use any controlled substance

(as defined by § 102 of the Controlled (as defined by § 102 of the Controlled Substances Act (21 U.S.C. § 802))?Substances Act (21 U.S.C. § 802))?



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• Are you a citizen or permanent resident of the Are you a citizen or permanent resident of the United States? United States? (CANT be national of Iran, Iraq, Syria, (CANT be national of Iran, Iraq, Syria,

Libya, Cuba, N. Korea, Sudan)Libya, Cuba, N. Korea, Sudan) • Are you illegally or unlawfully in the United Are you illegally or unlawfully in the United

States?States?• Have you ever been adjudicated as a mental Have you ever been adjudicated as a mental

defective or been committed to any mental defective or been committed to any mental institution?institution?

• Were you dishonorably discharged from the Were you dishonorably discharged from the Armed Services of the United States?Armed Services of the United States?

Restricted Persons Restricted Persons (cont)(cont)



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Making Biosafety and Making Biosafety and Biosecurity a PriorityBiosecurity a Priority

• The USA Patriot ActThe USA Patriot Act

• Institutional Safety CultureInstitutional Safety Culture



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USA PATRIOT ActUSA PATRIOT Act UUniting and niting and SStrengthening trengthening AAmerica by merica by PProviding roviding

AAppropriate ppropriate TTools ools RRequired to equired to IIntercept and ntercept and OObstruct bstruct TTerrorismerrorism

Signed: 10/26/2001Signed: 10/26/2001

• Restricted Use:Restricted Use: (Section 817) Possession of (Section 817) Possession of biological agents, toxins, or delivery systems in biological agents, toxins, or delivery systems in quantity or of a type that quantity or of a type that is not reasonably justified is not reasonably justified by a prophylactic, protective, bona fide research, by a prophylactic, protective, bona fide research, or other peaceful purpose.or other peaceful purpose.

• Restricted Persons:Restricted Persons: (Section 175b) Risk of (Section 175b) Risk of illegitimate use.illegitimate use.

• Violations:Violations: Allows imprisonment of up to 10 years. Allows imprisonment of up to 10 years.



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““Application for Lab Application for Lab Registration for Possession Registration for Possession Use, and Transfer of Select Use, and Transfer of Select

Agents or Toxins” Form:Agents or Toxins” Form:

APHIS/CDC Form 1APHIS/CDC Form 1(the forms previously known as (the forms previously known as CDC Form 0.1318 or APHIS Form CDC Form 0.1318 or APHIS Form

2040)2040)



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““The world is a dangerous place to live, not just The world is a dangerous place to live, not just because of the people who are evil, but because because of the people who are evil, but because

of the people who don’t do anything about it.”of the people who don’t do anything about it.”- Albert Einstein- Albert Einstein

New York State Department of Health Wadsworth Center BiodefenseLaboratoryN Y S D O H Select Agents and Associated Biosafety and Biosecurity Considerations.

Documents

listed biological agents

overlap agents

biological malfunction

biological product

animal health

agent ruleeffective

exemptionpublic health

effective death penalty