Hazard Risk Assessment - University of Kansas Medical Center

H a z a r d R i s k A s s e s s m e n t

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SECTION I Purpose

This form is a comprehensive assessment of all hazards associated with your research project and is intended to assist in eliminating occupational exposures that may lead to illness, injury or death.

This document must be completed electronically (not hand written) and sent via email to ehs@kumc.edu

in Microsoft Word format.

SECTION II General Information

Date

Project Title

Principal Investigator

Phone

Email

Department

Office Location

Laboratory Location

Secondary Contact

Phone

Email

List ALL individuals conducting research on your proposed project:

Last, First

Last, First

Last, First

Last, First

Last, First

Last, First

Last, First

Last, First

Last, First

2015-06-10

The University of Kansas Medical Center, Environment, Health & Safety (EHS)

3901 Rainbow Blvd., MS 3032, Kansas City, KS 66160, (913) 588-1081, ehs@kumc.edu, Website


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SECTION III Hazard Declaration - Part 1

SPECIAL NOTE:

This section refers to the use of recombinant DNA techniques. In regards to Donor/Vector/Host systems, two examples would be the below:

1.

You are using a plasmid (vector) from E. coli (donor) to transfect a bacteria (host).

2.

You are using DNA from one cell line (donor) to transfer into tumor cells (host) by means of a lentivirus or adeno-associated virus (vector).

Are you using any of the below systems?

Donor Yes No If Yes, explain:

Vector Yes No If Yes, explain:

Host Yes No

Is the material replication competent?

If Yes, explain:

Yes No If yes, explain below:

Are you using inserted sequences?

Yes No If yes, describe the source and function below:

Will there be an attempt to obtain expression of a foreign gene (e.g. expression of GFP inside a cell)?

Yes No If yes, describe the protein will be produced below:

What are the agent characteristics (e.g. virulence, pathogenicity, environmental stability, attenuation)?

What are the containment conditions to be implemented (e.g. biosafety level or other special provisions)?

What types of manipulations are planned (e.g. cell culture, administration to animals)?

NIH Guidelines (Section III-F)

Do you feel your research is exempt from the NIH Guidelines?

Yes No If Yes, explain:

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Indicate ALL hazard categories associated with your research project with an “X”.

Yes No

Select Pathogenic Agents

Select Toxins

Other Biological Toxins

Etiological Agents

Bloodborne Pathogens

Recombinant / Synthetic DNA

Hazardous Chemicals

Hazardous / Chemotherapeutic Drugs

Investigational Drugs

Human Cells / Tissue

Non-Human Primate Cells / Tissues

Non-Human Primate Research

Animal Research

Transgenic / Knockout Animal Models

Human Gene Therapy

Yes No

Radioactive Isotopes

Human Research (Clinical Trails)

Does the project involve the deliberate transfer of recombinant or synthetic

DNA or RNA derived from recombinant or synthetic nucleic acid molecules, into one or more human research participants?

If your answer is yes, do not continue with this document. Contact the Biosafety

Officer, Charles “Sonny” Cherrito (913-588-5206, ccherrito@kumc.edu).

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SECTION III Hazard Declaration - Part 2

Are you are submitting this Risk Assessment as an updated version of a previous one? If yes, please specify what changes have been made to your research project from the original submission:


Does your project involve any agents from the Select Agents and Toxins Exclusion List ?


Does your project involve any agents that fall under the CDC Restricted Experiments ?


Does your project involve any of these specific Toxins ?


Is your project considered Dual Use Research ?


Are you collaborating with another entity?


Has the collaborating institute’s IBC approved the research?

Yes No N/A If No, explain:

Is your project NIH Funded?

Yes No

Provide a brief abstract (in layman’s terms) regarding your research project as it pertains specifically to recombinant DNA, synthetic DNA or etiological agents (biological or toxin hazards):

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SECTION IV Biological Hazards

Does your project involve Biological Hazards? Yes

Denote all bacterial and viral agents (including plasmids) involved in your research project:

No

Biological

Agent

Hazard storage procedures:

Acquisition

Source

Hazard disposal procedures:

How Hazard Will Be Utilized

Hazard communication procedures:

Primary containment used when manipulating the hazard (e.g. BSC):

Personal protective equipment (PPE) used when manipulating the hazard:

Are you propagating cultures?


Does your project involve the use of prions?


Denote any safety information that personnel should be made aware (LD50 data, special precautions, metabolite and excretion data, etc.):

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SECTION V Toxin Hazards

Does your project involve Toxin Hazards?

Denote all toxins involved in your research project:

Yes No

Toxin

Name


Acquisition

Source




Primary containment used when manipulating the hazard (e.g. BSC, fume hood):


Are you propagating cultures that result in the production of toxins?


Denote how much of each toxin will be stored (stock-piled) at any given time (volume/weight):


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SECTION VI Chemical Hazards

Does your project involve Hazardous Chemicals?

Denote all hazardous chemicals involved in your project:

Yes

Chemical

Name


Acquisition

Source





No



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SECTION VII Drug Hazards

Does your project involve Hazardous Drugs? Yes No

Denote all drugs involved in your project and other names the drugs are known by (e.g. Generic):

Drug

Name


Acquisition

Source







Does your project involve Investigational New Drugs?


FDA Approved?

IND Number?

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SECTION VIII

Does your project involve Cells and/or Tissue?

List all human and animal cell lines/tissues involved in your project.

Cell Line or

Tissue

Cells & Tissue


Human or

Animal


Acquisition

Source

Yes No





Are you propagating cultures?


Does the material contain known hazardous agents or pathogens?


Has the material been screened for pathogens? If yes, denote the method and the results:


Denote any safety information that personnel should be made aware (e.g. special precautions):

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SECTION IX Whole Animal Research

Does your project involve Whole Animals?

Will you be breeding two different knockout (KO) strains together?

Yes No

Will you be breeding two different transgenic strains together?

Yes No

Will you be creating a novel strain? If yes, what will be the new strain?


Yes No

What is the ACUP number associated with this research?

Provide a brief abstract regarding your research project as it pertains specifically to recombinant DNA, synthetic DNA or etiological agents (biological or toxin hazards):

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SECTION X Personnel Training

Have all personnel completed the REQUIRED ANNUAL below online trainings found at https://tlc.netdimensions.com

or via my.kumc.edu

by accessing the TLC link under the “Training” tab ?

University Environment, Health & Safety General Safety, Online

University Hazard Communication & RCRA Chemical Safety Training, Online

Yes No

University Biosafety Safety Training, Online

University Bloodborne Pathogen Training, Online

University Personal Protective Equipment (PPE), Online

Describe any additional training completed you feel is relevant:

Do you have a laboratory specific safety plan and have all personnel been trained as to its contents?

Yes No If not, explain:

Please Note: The EHS Office can provide a general template (also found here ) that can assist you in creating this safety manual/plan. Creation of a lab safety plan is HIGHLY recommended for BSL-1 environments, but is a REQUIREMENT, per the NIH and the BMBL , for anyone operating within a BSL-2 or higher laboratory containment level.

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SECTION XI Recombinant & Synthetic DNA

NIH Guidelines (Section III-A)

Does the project involve the transfer of a drug resistance trait?


NIH Guidelines (Section III-B)

Does the project involve cloning a toxin with an LD50 of less than 100ng/kg body weight?

Yes

Yes

No

No

If Yes, explain:

NIH Guidelines (Section III-C)

Does the project involve the deliberate transfer of recombinant or synthetic DNA, or DNA/RNA derived from recombinant or synthetic DNA, into one or more human research participants?

If Yes, explain:

NIH Guidelines (Section III-D)

Does the project involve experiments using material at Risk Group 2, Risk Group 3, Risk Group 4, or

Restricted Agents as Host-Vector Systems ?

Yes

Yes

No

No

If Yes, explain:

Does the project involve experiments in which DNA from Risk Group 2, Risk Group 3, Risk Group 4, or

Restricted Agents are cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems?

If Yes, explain:

Does the project involve experiments using infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems?


Does the project involve more than 10 liters of culture?


Does the project involve experiments using influenza viruses?


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NIH Guidelines (Section III-E)

Does the project involve breeding two different knockout (KO) strains together? If yes, what biosafety level (ABSL) will they be housed?

Yes

Yes

No

No

If Yes, explain:

Does the project involve the formation of recombinant or synthetic DNA containing MORE than twothirds of the genome of any eukaryotic virus?

If Yes, explain:

Is the material a wild-type, mutant or chimeric gene?


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SECTION XII Final Comments

As we are a publicly funded organization, the University, at times, may receive requests to provide information on certain material (e.g. committee meeting minutes) that may be subject to public distribution per federal, state or local laws. Is there anything contained within in this document that should not be disclosed to the public upon a records request (e.g. propriety material, etc.)?


Please provide any additional comments in which you feel necessary for personnel to be informed in regards to safety precautions (cage changing procedures, animal handling, special training, vaccines, precautions for pregnant women and immunocompromised individuals, etc.). This information will greatly assist in mitigating an occupational exposure, injury or even death. Feel free to be as specific, detailed and descriptive as possible as this Risk Assessments integrity relies on the information you provide (this is clearly stated within the BMBL and NIH Guidelines ).

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Institutional Biosafety Committee (IBC) Registration

This portion is to be completed by all researchers that conduct research involving recombinant

DNA, synthetic DNA and/or Gene Therapy. The signed portion acts as a registration with the

KUMC IBC. This page is to be signed and submitted (email, hard copy, etc.) to the Environment,

Health & Safety Office. The PI must ensure that the information contained in this registration is accurate and complete. The PI accepts the responsibility for the safe conduct of work with this study at the Biological Safety Level practices and procedures assigned by the IBC. The PI will inform all personnel, who may be at risk of potential exposure regarding the work being conducted. The PI will assure that all personnel will receive adequate training to perform all activities safely and proficiently.

Where applicable, the PI agrees to comply with the NIH requirements pertaining to shipment and transfer of recombinant DNA materials. Additionally, as a condition of research approval and continuation, the PI acknowledges the responsibility for the conduct of this research in accordance with Section IV-B-7 of the NIH Guidelines. It is the PI’s responsibility to notify the

IBC of any changes in their protocol that involve the hazards mentioned in this application

(change in vehicle, dosing route, adverse events, etc.) and the PI must remain in communication with the IBC throughout the conduct of the project.

If the IBC chooses to inspect the facilities in which the material is handled, stored, prepared, transported, administered or disposed, it is the PI’s responsibility to arrange for the IBC or its members to gain access to the facilities. Lastly, the PI has the right to attend the portion of the

IBC meeting in which their protocol is discussed.

The PI shall comply with the reporting requirements for all incidents (adverse events, illnesses, injury, death, misconduct, protocol addendums, etc.) within 30 days to the NIH as outlined in the NIH Guidelines, Section IV-B-7. The PI understands that the entities that are to receive the report include, at a minimum, the NIH/OBA and the IBC. Additionally, the PI may

be required to notify other appropriate authorities that are associated with this research.

Signature - Principle Investigator (PI) Date

2015-06-10



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