UW Oshkosh

Office of Sponsored Programs and Faculty Development

Institutional Biosafety Committee

BIOLOGICAL TOXIN REGISTRATION FORM

IBC Use Only
Registration Number:
Submission Date:

Please submit one (1) hard copy of this form with required signatures to the Office of Grants and Faculty Development, Dempsey Hall 214. You must also submit one (1) electronic copy to . ALL individuals listed on this registration must provide a copy of their CITI completion reports attached to this form. Instructions for completing CITI training can be found at the bottom of this registration. Your registration will not be processed until the signed hard copies and CITI training documentation are received.

I. Cover Page: Project Identification, Personnel and Signatures

PROJECT TITLE:
PRINCIPAL INVESTIGATOR/INSTRUCTOR: / Phone No:
E-Mail:
CO-PI/INSTRUCTOR: / Phone No:
E-Mail:
COURSE NUMBER:
COURSE TITLE:
Department:
Funding Agency: / Grant Identification Number (if federally funded):
New Submission Renewal Revision/Resubmission

Financial Conflict of Interest (FCOI) Statement:

Principal Investigators, Co-Principal Investigators, and any other person responsible for the design, conduct, or reporting of the research project who hold significant financial interests related to the project must file a Financial Conflict of Interest (FCOI) Disclosure Form with the Office of Sponsored Programs and Faculty Development and complete appropriate FCOI training through CITI Program. Questions regarding this process can be found on the OSPFD website or by contacting OSPFD at or 920-424-3215.

Useful Resources:

Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

American Biological Safety Association (ABSA) Risk Group Database

American Type Culture Collection (ATCC)

PI Certification:

By signing below I am agreeing that all work on this project will be conducted using biological safety practices described in the CDC/NIH publication titled “Biosafety in Microbiological and Biomedical Laboratories” (BMBL) and by additional stipulations set forth by the University of Wisconsin Oshkosh Institutional Biosafety Committee (IBC). If the IBC approves this Biological Toxin Registration Form, I agree to execute this research as described; request approval from the IBC for modifications; comply with the guidelines set forth by the IBC, and be responsible for the training, supervision and work of my staff. I realize that failure to adhere to the policies related to this research may result in suspension or revocation of permission to perform this research at UWO facilities.

Signature of PI: Date:

Signature of Co-PI: Date:

Signature of Department Chair: Date:

Important Information Before you Begin:

Standard Laboratory Practices for Biological Toxin Work
·  All Biological Toxin use must be registered with the IBC
·  A minimum of Biosafety Level 2 practices and containment will be used for activities involving all biological toxin work, following institutional policy.
·  Biohazard signs and labels must be displayed in areas and on equipment where use and storage of biological toxins occur (i.e. laboratory entranceways, biological safety cabinets, freezers, refrigerators, etc.)
·  When biological toxins are in use, a sign must be displayed on the lab entranceway stating “Toxins in Use: Restricted Entry”
·  Use of a biological safety cabinet (BSC) or a chemical fume hood for resuspension of biological toxins or manipulations of stock solutions of toxins that can generate aerosols is required
View Appendix A “Examples of Biological Toxins and LD50 Information” for a list of examples of biological toxins and their LD50 values


II. Class Determination

A. Check the appropriate section(s) below to determine which class the proposed work would fall under.

Experiments utilizing biological toxins for purposes other than use or study of recombinant DNA or synthetic nucleic acid molecules. PROCEED WITH THIS REGISTRATION FORM

Experiments utilizing biological toxins for purposes involving recombinant DNA or synthetic nucleic acid molecules

STOP! IF YOU SELECTED THIS CATEGORY YOU SHOULD COMPLETE THE IBC PROTOCOL APPLICATION FOR NON-EXEMPT ACTIVITIES. DO NOT PROCEED WITH THIS REGISTRATION

III. Research Personnel

A. Identify personnel conducting the experiments (including students). Specify Name, Degree, CITI Training Completion Date, and Project Responsibilities.

Name
/
Degree
/
CITI Training Completion Date
/
Project Responsibilities

Attach a separate sheet if more space is required

B. Provide details on the type(s) of project-specific training all personnel listed above have received. Include hands-on training, training via supervisor, workshops, etc.

VI. Project Abstract

A. Provide a brief description of the proposed research or teaching activity in such a way that a scientist in another field will understand (layman’s terms). You must include the following: 1. Brief Introduction, 2. Goals/Purpose, 3. Experimental Methods to Be Used, and 4. Outcomes to be Measured. You can find an example list of toxins and quantities that would require registration with the UW Oshkosh IBC in Appendix A: “Biological Toxins Requiring an IBC Protocol.”

VI. Research Facilities

Provide information on where the materials listed in this application will be used, stored, and handled.

Building Name / Room Number / Biosafety Level (BSL-1 or BSL-2) / Use of Room (animal housing, research lab, teaching lab, storage room, growth chamber, etc.)

Attach an additional sheet if more space is required.

IV. Animal Use

Any use of animals for research, teaching or testing purposes must receive approval from the UW Oshkosh Institutional Animal Care and Use Committee (IACUC) prior to Institutional Biosafety Committee (IBC) approval. The IACUC requires that the researcher submit an IACUC Protocol Application for approval of animal use. Contact for more information. IACUC forms can be found at www.uwosh.edu/grants/forms. Please note that the IACUC holds 1-4 meetings per semester and requires the PI to submit protocol applications at minimum two weeks before the next scheduled meeting. IACUC meeting dates can be found at: www.uwosh.edu/grants/iacuc-meeting-dates

A. Does the experiment involve the infection and/or use of animals? Yes No (If “No”, skip this section)

If “Yes”, you must have an approved IACUC Protocol Application on file with the IACUC office prior to beginning work with toxins. Contact for more details.

B. List animal specie(s) used under the procedures outlined in this registration. Include species that are exotic, immunocompromised and/or used in combination with biological toxins. Explain how use of this particular specie(s) is scientifically justified:

C. Disinfection/Inactivation (Animal)

Indicate the procedure(s) used to disinfect or inactivate contaminated surfaces and materials at the completion of work.

Animal Species / Animal Bedding/Wastes / Animal Carcasses / Animal Cages/Pens

V. Plant Use

A. Does the experiment involve the use of plants? Yes No (if “No”, skip this section).

Complete this section if plants are utilized in conjunction with biological toxin use and/or production activities. List each genus and species of plant used in your research:

B. Disinfection/Inactivation (Plant)

Indicate the procedure(s) used to disinfect or inactivate contaminated surfaces and materials at the completion of work.

Plant Species / Plant Materials / Soil / Pots/Containment

VII. LD50 and Quantity Information

A. Provide mammalian LD50 information for any biological toxins proposed for use. Information on LD50 for certain biological toxins can be found in Appendix A. This information may also be available in a Safety Data Sheet (SDS) provided by the source company.

Definition: Lethal Dose 50 (LD50): the amount of a toxin that is sufficient to kill 50 percent of a population of animals within a given time

B. What amount of biological toxin will you have in stock at any given time?

VIII. Source

A. Explain how the toxin will be acquired:

Laboratory Stock
Off-campus Collection
Off-campus Researcher
Directly from animal/plant tissues
Other (describe):

IX. Transportation

A. Will biological toxins be transported between locations (i.e. between labs in the same building, between different buildings on campus, between campus and satellite off-campus locations)?

No (If “No”, skip this section)

Yes

B. Please explain transportation procedures:

X. Storage and Security

A. Explain how the toxin will be stored and maintained while at UW Oshkosh facilities. Include information on security to ensure unauthorized people cannot access the toxin:

Lypholized
Chemical-fixation
Refrigerator (Provide location: )
Freezer (Provide location: )
Storage Cabinet (Provide location: )
Incubator (Provide location: )
In vivo (Also complete Appendix A)
Other (describe):

B. Will storage space(s) be secured or locked? Provide explanation including who will have access to the toxin(s):

VI. Disposal/Disinfection/Inactivation (General)

A. Explain how materials containing the biological toxin are inactivated and disposed. If a chemical disinfectant is used, state the kind and concentration. Explain how liquid waste and/or solid waste contaminated with toxin will be inactivated and disposed of, as applicable. Reference: http://www.uwosh.edu/ehs/environmental

Additional information may also be found in Section VIII-G of the 5th Edition of the BMBL

XII. Personal Protective Equipment

A. Select the personal protective equipment (PPE) to be worn for the procedures described on this form. Questions regarding PPE requirements should be directed to

Important: For work with biological toxins, a minimum of disposable gloves, lab coat, and eye protection (safety glasses or goggles) are required

Hand Protection
Examination gloves
Heat resistant gloves
Cold resistant gloves
Eye Protection
Safety glasses
Goggles
Face shield
Goggles + Face shield
Body
Laboratory coat (white)
Scrubs
Blue smock/coveralls
Tyvek body suit
Waterproof boots
Hair
Hair cover/hat
Respiratory
Guidance on respirator selection can be found at: http://www.cdc.gov/niosh/docs/2005-100/pdfs/2005-100.pdf
N-95 mask
Air purifying respirator (half mask/particulate)
Air-supplied respirator
Other (Explain):

XIII. Safety Equipment

A. Select the safety equipment to be utilized for the procedures described on this form.

Biosafety Cabinet:
Will your work require use of a biosafety cabinet?
Yes No
Cabinet Class: I II III / Autoclave:
Will your work require use of an autoclave?
Yes No / Centrifuge Containment:
Will your work require use of a centrifuge?
Yes No
Model: / Autoclave Location: / Sealed buckets/rotors? Yes No
Cabinet Location: / Autoclave Testing Method: / Rotor opened in BSC? Yes No
Certification Date**: / Autoclave Testing Frequency: / Centrifuge inside BSC? Yes No
Other Equipment (Explain):

** Biosafety cabinets under regular use must be certified on an annual basis by experienced personnel or through a contracted and licensed company.

Class I cabinets are ventilated for personnel protection and have an inward flow of air away from operator. Exhaust air is filtered through a HEPA filter. Class II cabinets are ventilated for personnel and product protection having an open front with inward air flow for personnel protection, and HEPA filtered mass recirculated air flor for product protection. Exhaust air is filtered through a HEPA filter. Class III cabinets are closed-front ventilated cabinets with gas tight construction which provide the highest level of personnel protection. The cabinet is fitted with arm-length rubber gloves and is operated under negative pressure. All supply air is filtered through HEPA filters. Exhaust air is filtered through two HEPA filters or one HEPA filter and one incinerator.

Autoclave testing: Autoclave efficacy testing must occur on a regular basis. Monthly testing is generally the acceptable frequency but this should be confirmed with your department stockroom manager or department chairperson. Testing method can include spore vials, spore strips, or chemical strips.

Emergency Preparedness

This section requests a summary of all emergency response plans that are in place for your laboratory or work space.

XIV. Emergency Contact information

A. Provide emergency contact information for the following:

i. PI and Research Staff

ii. Program Staff

iii. Student Health Center, personal physician or physician familiar with toxin, Environmental Health and Safety, chemical disposal contact or company, etc.

XV. Associated Health Risks

A. Describe the health risks, as applicable, associated with the toxin(s) you will use. Include information on available vaccines and their recommended use for persons handling the toxin.

XVI. Potential Exposure Hazards

A. Identify potential exposure hazards (e.g., aerosol generation when transferring, mixing, or centrifuging, accidental inoculation, ingestion, use of needles/sharps, etc.). If toxins will be used in animals, be sure to specify additional risks related to animal handling, husbandry or by-products.

B. Explain the procedure for mitigation if an exposure were to occur. How will personnel health/safety be protected?

XVI. Accidental Spill and Containment Breach Response

A. Provide a spill response and/or containment breach procedure, as applicable, that will be utilized in the event of a spill or breach. What steps will be taken to ensure the spill or breach is contained? Who will be contacted?

XVIII. Aerosol Generating Activities

Certain laboratory procedures are at risk for generating aerosols from solid or liquid materials. If not properly contained, these activities can result in a laboratory-acquired infection for staff.

A. Do you perform any of the following activities with the materials listed in this protocol?

Vortexing/Blending/Sonicating/Homogenizing

Opening lyophilized cultures, culture plates, ampoules, tubes and bottles

Flaming inoculating needles, slides or loops

Animal inoculations

Animal cage changes

Necropsy

Other (Explain below)

B. Are you working with any of the materials mentioned in this application outside of containment (on a lab bench without closed containers)?

Yes No

If “Yes”, explain below. Specify which biological materials are used outside of containment. Include the procedure used with the materials.

XIX. Violations to Safety Protocol

A. Explain what steps will be taken if personnel are found to be performing work out of compliance with established laboratory safety protocols or procedures.

Please note that any incidents such as exposures, personal injury (needle stick), accidental spills, or containment breaches where biological toxins are utilized must be reported to the Institutional Biosafety Committee within 24 hours by completing the IBC Incident Report form and e-mailing to

FOR IBC USE ONLY:

Reviewer’s Recommendations:

Reviewer requests Full Committee Review
Reviewer Requests Further Information (Explain below)
Reviewer Requests Consultation from Ad Hoc Consultant (Explain Below)
Reviewer is satisfied with the Biological Toxin Registration and safety plan.
Additional Information (Explain below):
Reviewer Name: Review Date:
Full Committee Review Determination: Review Date:

Instructions for CITI Training for Biosafety and Security Program (BSS):

1.  Enter the training at www.citiprogram.org

a.  Select: New Users Register Here

b.  Create your profile and affiliate with University of Wisconsin Oshkosh.