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??Where do I go for help??

Biosafety Officer – 241-5169Biosafety Officer – 241-5169 Fax – 241-6695Fax – 241-6695 Philip.hauck@mssm.edu Philip.hauck@mssm.edu www.mssm.edu/biosafetywww.mssm.edu/biosafety www.cdc.gov/od/ www.cdc.gov/od/

INTRODUCTIONINTRODUCTION

42 CFR Part 73 Chapter 142 CFR Part 73 Chapter 1 Became effective on 2 / 7 / 03!Became effective on 2 / 7 / 03! Involves MSSM AdministrationInvolves MSSM Administration Involves PI’s, Research Staff, Post-doc’sInvolves PI’s, Research Staff, Post-doc’s Impacts Impacts AnyoneAnyone who will access Select who will access Select

Agents and ToxinsAgents and Toxins

INTRODUCTIONINTRODUCTION

Has major impact on everyone working Has major impact on everyone working with SA’s and T’s!with SA’s and T’s!

Security Clearances and CDC approvals Security Clearances and CDC approvals required before you can access SA&T’srequired before you can access SA&T’s

Archimedes and the Romans –failure to Archimedes and the Romans –failure to heed the “regulators” cost Archimedes his heed the “regulators” cost Archimedes his life!life!

What are Select Agents?

What are Select Agents?What are Select Agents?

HHS select agent or toxinHHS select agent or toxin means a biological agent or toxin means a biological agent or toxin included in § 73.4included in § 73.4..

(list posted at www.mssm.edu/biosafety)(list posted at www.mssm.edu/biosafety)

Overlap select agent or toxinOverlap select agent or toxin means a biological agent ormeans a biological agent ortoxin included in § 73.5. (CDC and USDA have jurisdiction)toxin included in § 73.5. (CDC and USDA have jurisdiction)

Genetic material, expression products, virulence factors,Genetic material, expression products, virulence factors,engineered vectors from the agents in the two definitionsengineered vectors from the agents in the two definitionsabove- all are above- all are NOW REGULATEDNOW REGULATED

What are Select Agents?What are Select Agents?

Biological agentBiological agent means any microorganism (including, but not means any microorganism (including, but not limited to, bacteria, viruses, fungi, rickettsiae, or limited to, bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substance, or protozoa), or infectious substance, or anyany naturally occurring, bioengineered, or synthesized naturally occurring, bioengineered, or synthesized component of any such microorganism or component of any such microorganism or infectious substanceinfectious substance, capable of causing death, , capable of causing death, disease, or other biological malfunction in a disease, or other biological malfunction in a human, an animal, a plant, or another living human, an animal, a plant, or another living organism; deterioration of food, water, equipment, organism; deterioration of food, water, equipment, supplies, or material of any kind; or deleterious supplies, or material of any kind; or deleterious alteration of the environment. alteration of the environment.

i.e.-i.e.-It’s not just organisms!!!It’s not just organisms!!!

What are Select Agents?What are Select Agents?

There are certain strains of Select Agents that There are certain strains of Select Agents that are exemptare exempt from reporting to the CDC or USDA, as well as sub-genomic from reporting to the CDC or USDA, as well as sub-genomic fractions that do not code for toxins or virulence factorsfractions that do not code for toxins or virulence factors

Also, Toxins stocks that are below listed quantities are also Also, Toxins stocks that are below listed quantities are also exempt; if exceeded-you need to follow all rulesexempt; if exceeded-you need to follow all rules

Check with the BioSafety Officer for more information-241- Check with the BioSafety Officer for more information-241- 51695169

http://www.selectagents.gov/Select%20Agents%20andhttp://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html%20Toxins%20List.html

What Safety Categories do Select Agents fall into?

What Safety Categories do Select Agents fall into?What Safety Categories do Select Agents fall into?

Risk Group 3 (RG3) Agents that are associated with serious or lethal Risk Group 3 (RG3) Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions human disease for which preventive or therapeutic interventions may be may be available (high individual risk but low community risk)available (high individual risk but low community risk)

Risk Group 4 (RG4) Agents that are likely to cause serious or lethal Risk Group 4 (RG4) Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions human disease for which preventive or therapeutic interventions are are not usually not usually available (high individual risk and high community available (high individual risk and high community risk)risk)

Some are Risk Group 2 (RG2) AgentsSome are Risk Group 2 (RG2) Agents

What Safety Practices are needed?

What Safety Practices are needed?What Safety Practices are needed?

BioSafety Level 2 is a BioSafety Level 2 is a minimumminimum safety safety level when working with Select Agentslevel when working with Select Agents

Biosafety Level 3 is needed for those Biosafety Level 3 is needed for those agents that are capable of agents that are capable of airborne airborne transmissiontransmission

Carefully consider aerosol generation Carefully consider aerosol generation ~ airborne transmission!~ airborne transmission!

What Security Practices must I and my staff use?

What Security Practices must I and my staff use?What Security Practices must I and my staff use?

You You (yes, YOU)(yes, YOU) must: must: Be investigated and approved by the US Dept. Be investigated and approved by the US Dept.

of Justice to work with SA’sof Justice to work with SA’s Control access to areas where Select Agents and Control access to areas where Select Agents and

Toxins are storedToxins are stored LOG-IN each time access is made to a storage LOG-IN each time access is made to a storage

area area LOG-IN quantities removed (and by whom)LOG-IN quantities removed (and by whom)

What Security Practices must I and my staff use?What Security Practices must I and my staff use?

Keep a record of all approved employees who Keep a record of all approved employees who have access to SA’s and T’shave access to SA’s and T’s

Escort unapproved individuals into sensitive Escort unapproved individuals into sensitive areas-logging in / out all activitiesareas-logging in / out all activities

Know who is in your area at all timesKnow who is in your area at all times Have numbers handy to obtain Security Have numbers handy to obtain Security

assistance to eject assistance to eject “undesirables”“undesirables” Have an Emergency Plan in case of an incident / Have an Emergency Plan in case of an incident /

accidental release re: SA’s & T’saccidental release re: SA’s & T’s

What Security Practices must I and my staff use?What Security Practices must I and my staff use?

DOCUMENT- agents usedDOCUMENT- agents used DOCUMENT- quantities and locationsDOCUMENT- quantities and locations DOCUMENT- authorized peopleDOCUMENT- authorized people DOCUMENT – DOCUMENT –

all transfers of SA’s & Tall transfers of SA’s & T’s’s

Develop a Policy Manual for your labDevelop a Policy Manual for your lab

What must I do to comply with sending / receiving

Select Agents?

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

Comply with all requirements of 42 CFR Part 73 and submit an Comply with all requirements of 42 CFR Part 73 and submit an application to CDC and / or USDAapplication to CDC and / or USDA

You You must apply for must apply for and receiveand receive a New Registration or an a New Registration or an Amendment to the MSSM Certificate of Registration from the CDC Amendment to the MSSM Certificate of Registration from the CDC and / or USDA and / or USDA

Obtain from the MSSM Biosafety Officer an Form 2 for Obtain from the MSSM Biosafety Officer an Form 2 for allall transfers transfers of SA’s and T’sof SA’s and T’s

NO TransfersNO Transfers / work/ work without an Amendment or a Form 2! 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 Contact the MSSM Biosafety Officer to obtain assitance assitance before filing any documentsbefore filing any documents

Go to: www.mssm.edu/biosafetyGo to: www.mssm.edu/biosafety Find: Find: Additional Requirements for Facilities Additional Requirements for Facilities

Transferring or Receiving Select Agents Transferring or Receiving Select Agents – read all – read all info info carefullycarefully

Fill- out / send to CDC Select Agent ProgramFill- out / send to CDC Select Agent Program Obtain all necessary permits that apply Obtain all necessary permits that apply beforebefore

importing/exporting/transporting SA’simporting/exporting/transporting SA’s

Where do I go for Help??Where do I go for Help??

• www.mssm.edu/biosafety

• http://www.cdc.gov/od/ohs/

• http://www.selectagents.gov/

• http://www.usda.gov/