Transcript Select Agent Slide Presentation - Mount Sinai School of Medicine

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??
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Biosafety Officer – 241-5169
Fax – 241-6695
[email protected]
www.mssm.edu/biosafety
www.cdc.gov/od/
INTRODUCTION
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42 CFR Part 73 Chapter 1
Became effective on 2 / 7 / 03!
Involves MSSM Administration
Involves PI’s, Research Staff, Post-doc’s
Impacts Anyone who will access Select
Agents and Toxins
INTRODUCTION
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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
Archimedes and the Romans –failure to
heed the “regulators” cost Archimedes his
life!
What are Select Agents?
What are Select Agents?
HHS select agent or toxin means a biological agent or toxin
included in § 73.4.
(list posted at www.mssm.edu/biosafety)
Overlap select agent or toxin means a biological agent or
toxin included in § 73.5. (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?
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Biological agent
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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!!!
What are Select Agents?
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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
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Also, Toxins stocks that are below listed quantities are
also exempt; if exceeded-you need to follow all rules
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Check with the BioSafety Officer for more information241- 5169
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http://www.selectagents.gov/Select%20Agents%20and%20Toxins%
20List.html
What Safety Categories do Select Agents
fall into?
What Safety Categories do Select Agents fall
into?
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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)
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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)
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Some are Risk Group 2 (RG2) Agents
What Safety Practices are
needed?
What Safety Practices are needed?
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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
Carefully consider aerosol generation ~
airborne transmission!
What Security Practices
must I and my staff use?
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
 Control access to areas where Select Agents and
Toxins are stored
 LOG-IN each time access is made to a storage
area
 LOG-IN quantities removed (and by whom)
What Security Practices must I and my staff use?
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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
Know who is in your area at all times
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
What Security Practices must I and my staff use?
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DOCUMENT- agents used
DOCUMENT- quantities and locations
DOCUMENT- authorized people
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?
What must I do to comply with sending /
receiving Select Agents?
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Comply with all requirements of 42 CFR Part 73 and submit an
application to CDC and / or USDA
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You must apply for and receive a New Registration or an
Amendment to the MSSM Certificate of Registration from the CDC
and / or USDA
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Obtain from the MSSM Biosafety Officer an Form 2 for all transfers
of SA’s and T’s
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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?
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Contact the MSSM Biosafety Officer to obtain
assitance before filing any documents
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Go to: www.mssm.edu/biosafety
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Find: Additional Requirements for Facilities
Transferring or Receiving Select Agents – read all
info carefully
Fill- out / send to CDC Select Agent Program
Obtain all necessary permits that apply before
importing/exporting/transporting SA’s
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Where do I go for Help??
• www.mssm.edu/biosafety
• http://www.cdc.gov/od/ohs/
• http://www.selectagents.gov/
• http://www.usda.gov/