Mount Sinai School of Medicine Select Agents Training Philip G. Hauck, MS, MSHS, CIH, CBSP, SM(NRCM) 10/2012 Edition

Where do I go for help?? Biosafety Officer – Biosafety Officer – Fax – Fax –

INTRODUCTION 42 CFR Part 73 Chapter 1 42 CFR Part 73 Chapter 1 Became effective on 2 / 7 / 03! Became effective on 2 / 7 / 03! Involves MSSM Administration Involves MSSM Administration Involves PI’s, Research Staff, Post-doc’s Involves PI’s, Research Staff, Post-doc’s Impacts Anyone who will access Select Agents and Toxins Impacts Anyone who will access Select Agents and Toxins

INTRODUCTION Has major impact on everyone working with SA’s and T’s! Has major impact on everyone working with SA’s and T’s! Security Clearances and CDC approvals required before you can access SA&T’s Security Clearances and CDC approvals required before you can access SA&T’s Archimedes and the Romans –failure to heed the “regulators” cost Archimedes his life! Archimedes and the Romans –failure to heed the “regulators” cost Archimedes his life!

What are Select Agents?

HHS select agent or toxin means a biological agent or toxin included in § (list posted at Overlap select agent or toxin means a biological agent or toxin included in § (CDC and USDA have jurisdiction) Genetic material, expression products, virulence factors, engineered vectors from the agents in the two definitions above- all are NOW REGULATED

What are Select Agents? Biological agent Biological agent means any microorganism (including, but not limited to, bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substance, or any naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious substance, 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. i.e.-It’s not just organisms!!! i.e.-It’s not just organisms!!!

What are Select Agents? There are certain strains of Select Agents that are exempt from reporting to the CDC or USDA, as well as sub-genomic fractions that do not code for toxins or virulence factors There are certain strains of Select Agents that are exempt from reporting to the CDC or USDA, as well as sub-genomic fractions that do not code for toxins or virulence factors Also, Toxins stocks that are below listed quantities are also exempt; if exceeded-you need to follow all rules Also, Toxins stocks that are below listed quantities are also exempt; if exceeded-you need to follow all rules Check with the BioSafety Officer for more information Check with the BioSafety Officer for more information List.html 20List.html 20List.html 20List.html

What Safety Categories do Select Agents fall into?

Risk Group 3 (RG3) Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk) Risk Group 3 (RG3) Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk) Risk Group 4 (RG4) Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk) Risk Group 4 (RG4) Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk) Some are Risk Group 2 (RG2) Agents Some are Risk Group 2 (RG2) Agents

What Safety Practices are needed?

BioSafety Level 2 is a minimum safety level when working with Select Agents BioSafety Level 2 is a minimum safety level when working with Select Agents Biosafety Level 3 is needed for those agents that are capable of airborne transmission Biosafety Level 3 is needed for those agents that are capable of airborne transmission Carefully consider aerosol generation ~ airborne transmission! Carefully consider aerosol generation ~ airborne transmission!

What Security Practices must I and my staff use?

You (yes, YOU) must: Be investigated and approved by the US Dept. of Justice to work with SA’s Be investigated and approved by the US Dept. of Justice to work with SA’s Control access to areas where Select Agents and Toxins are stored Control access to areas where Select Agents and Toxins are stored LOG-IN each time access is made to a storage area LOG-IN each time access is made to a storage area LOG-IN quantities removed (and by whom) LOG-IN quantities removed (and by whom)

What Security Practices must I and my staff use? Keep a record of all approved employees who have access to SA’s and T’s Keep a record of all approved employees who have access to SA’s and T’s Escort unapproved individuals into sensitive areas-logging in / out all activities Escort unapproved individuals into sensitive areas-logging in / out all activities Know who is in your area at all times Know who is in your area at all times Have numbers handy to obtain Security assistance to eject “undesirables” Have numbers handy to obtain Security assistance to eject “undesirables” Have an Emergency Plan in case of an incident / accidental release re: SA’s & T’s Have an Emergency Plan in case of an incident / accidental release re: SA’s & T’s

What Security Practices must I and my staff use? DOCUMENT- agents used DOCUMENT- agents used DOCUMENT- quantities and locations DOCUMENT- quantities and locations DOCUMENT- authorized people DOCUMENT- authorized people DOCUMENT – DOCUMENT – all transfers of SA’s & T ’s Develop a Policy Manual for your lab

What must I do to comply with sending / receiving Select Agents?

Comply with all requirements of 42 CFR Part 73 and submit an application to CDC and / or USDA Comply with all requirements of 42 CFR Part 73 and submit an application to CDC and / or USDA You must apply for and receive a New Registration or an Amendment to the MSSM Certificate of Registration from the CDC and / or USDA You must apply for and receive a New Registration or an Amendment to the MSSM Certificate of Registration from the CDC and / or USDA Obtain from the MSSM Biosafety Officer an Form 2 for all transfers of SA’s and T’s Obtain from the MSSM Biosafety Officer an Form 2 for all transfers of SA’s and T’s NO Transfers / work without an Amendment or a Form 2! NO Transfers / work without an Amendment or a Form 2!

How do I go about obtaining permission to work with Select Agents?

How do I go about obtaining permission to work with Select Agents? Contact the MSSM Biosafety Officer to obtain assitance before filing any documents Contact the MSSM Biosafety Officer to obtain assitance before filing any documents Go to: Go to: Find: Additional Requirements for Facilities Transferring or Receiving Select Agents – read all info carefully Find: Additional Requirements for Facilities Transferring or Receiving Select Agents – read all info carefully Fill- out / send to CDC Select Agent Program Fill- out / send to CDC Select Agent Program Obtain all necessary permits that apply before importing/exporting/transporting SA’s Obtain all necessary permits that apply before importing/exporting/transporting SA’s

Where do I go for Help??