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Section II.Descriptions of laboratories and procedures for work with select agents in your department 

Before Completing the survey, please print out the Select Agents Information Table to mail to
Susan Welch at OEHS TW-16
Please provide the following information:

 
                 1.              State the name of the individual responsible for the laboratory (e.g., principal
                                   investigator or laboratory supervisor).
                                  
2.             Include a current resume or Curriculum Vitae from the principal investigators for our files.
3.             Briefly state (paragraph in length) the objectives of the work that will done with the select agent(s), including a description of the type of methodologies or laboratory procedures that will be used. State if you will be working with any host-vector systems. If you will be working with live agent as well as recombinant DNA and/or nonviable DNA, then include these procedures in your description.
SEND THIS ONE VIA CAMPUS MAIL TO SUSAN WELCH AT OEHS TW-16!
4.              Include a diagram of the floor plan (preferably not blueprints) showing the layout and rough dimensions of the laboratory(s) where select agents will be handled or stored. Clearly indicate on your diagram the following:
                a) entry and exit ways 
b) incubators
c) autoclaves 
d) eyewash and emergency shower stations 
e) biosafety cabinets (BSCs) 
f ) fume hoods centrifuges, and any other major laboratory equipment present in
     the laboratory

g) air supply and exhaust vents 
h) freezers 
i ) sinks
5.            State whether a Biosafety Cabinet (BSC) will be used. If yes, then describe the
procedures to be done in the BSC. State what type of BSC will be used (e.g., Class 2, Type B2). Describe if the BSCs are recalculating, or directly exhausted. If the BSC exhaust is connected to the building exhaust system, provide details of exhaust ductwork (hard-ducted or thimble connection). State how often the BSCs are inspected and certified.

               
6.             State whether a chemical fume hood will be used. If yes, then describe the procedures to be performed in the chemical fume hood. State what type of filters, if any, are utilized with the chemical fume hood. Is there a visual method to verify inward airflow? State how often the fume hood is certified and the filters, if present, are changed.
               
7.            Describe how your facility limits access to the laboratories where select agents are being manipulated and stored to only authorized and qualified persons (e.g., is there a guard at the entrance? Card key access? Door keys or combination-locked?)
               
7a)          Describe the policy in place to limit further access to this laboratory and/or storage area when a temporary employee (e.g., students, post-doctoral fellows, etc.) leaves the facility.
7b)          Are only personnel working with the select agents allowed in the specified laboratory? If not, who else is allowed? Are guests escorted in the laboratory at all times? Are maintenance personnel allowed in the laboratory? How many people have access to the laboratory where select agents are handled or stored?

7c)           Is the laboratory secured when no one is present during regular working hours?
8.            Does an Institutional Biosafety Committee (IBC) review and approve protocols prior to working with select agents at this facility? If yes, then has the IBC approved the work proposed in this application?
                              
9.             Is the facility inspected by USDA, FDA, CLIA, DoE, DoD or others? If yes, then give date of last inspection(s).
                               

Section III.Applicants working with infectious select agents

1.            Provide a brief summary regarding the strains of organisms that will be used. Provide an estimate of the maximum quantities (e.g., number of Petri dishes or flasks) and concentration of organisms grown at a given time.
                               
Section IV.Applicants working with select agent genomic DNA or nonviable organisms

1.             We strongly recommend that your facility request written verification that materials has been rendered nonviable from each of the facilities for which you receive select agent DNA or nonviable organisms. These recommendations are made in the interest of the health and safety of the laboratorians in your facility that will be working with the select agent material, and is particularly critical due to the severe illnesses that many of these agents cause. Provide a concise assurance on the following points regarding inactivation of live agent:

1a)           A procedure is in place for inactivating live agent.
               
1b)          The procedures employed for inactivating live agent have been  verified.
                               
Section V.Applicants working with recombinant DNA
1.            Give an estimate of the range in length (in base pair's) of the recombinant select DNA material and what it encodes for.
                              
2.             What type of host-vector system(s) will be used?
                               
Section VI.Applicants working with small animals (ABSL2 - ABSL4)
1.              What route of infection will be used with the select agent(s)?
                                
2.             Facilities for laboratory animal studies should be physically separate from areas with other activities, such as clinical laboratories and those that provide patient care. Include with your sketch of the floor plan (question number 3 above), another sketch that shows the animal rooms to be used and rooms adjacent to them. Indicate what type(s) of activities are conducted in areas adjacent to the animal rooms.
                               
3.             Does the facility require that an institutional Animal Care and Use Committee (IACUC) review and approve protocols prior to work with animals at this facility? If yes, has the proposed work with select agents in small animals been approved by the IACUC?
                               
4.             Is the laboratory space described in this application AAALAC accredited? If yes, when was the data of the last inspection for these rooms?
                               
Section VII.Applicants working with select agent toxins
1.             Clearly state the form(s) of the toxin that will be used (e.g., are the toxins received in liquid or dry form?). If the toxin is received in dry form, describe decontamination procedures prior to removing materials from the chemical fume hood.
                               
2.            What concentration of toxins will be handled? What volume of toxins are you working with or storing?
                                
3.             Are dilution procedures and other manipulations of the concentrated toxins conducted in a fume hood or biosafety cabinet with two knowledgeable people present? Is there is a hazard sign on the door when toxins are present?
                                
4.             If toxins are to be produced from live agent, then briefly describe procedures used for doing so. Include in your summary an estimate of the maximum quantities (e.g., number of plates) grown at a given time.
                               


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