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Brown UniversityApplication for Biological Research Authorization

Please complete page 2 (and 3 if applicable) and only those sections below (I-V) that are relevant to the laboratory’s use of biological materials (e.g.; microorganisms, cell lines, human materials, animals, arthropods, toxins etc.).

PI NAME:______________________________________

One application per grant-funded, or University-funded project is NOT necessary. If one application can give detail for multiple projects, please give the application a title fitting of the general work that will be done on those projects. Completed applications must be signed electronically on page 13.

I. Recombinant or Synthetic Nucleic Acid Molecule Experiments (p. 4) This section must be completed if the research involves the use of (i) molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids; (ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or (iii) molecules that result from the replication of those described in (i) or (ii) above (including nucleic acids that integrate into the genome)

II. Microorganisms (p.8) This section must be completed if the research involves the use of microbial agents including bacteria, viruses and protozoa

III. Human/Non-Human Primate Materials including cell lines, blood, bodily fluids (p.9) and tissuesThis section must be completed for research using any of the above including screened/established human/non-human primate blood, body fluid, cell lines, urine and saliva

IV. Animals, Arthropods, Insects, Plants, Fungi or their tissues, fluids, cells (p.10) This section must be completed if the research includes any of the above

V. Biological Toxins (p.12) This section must be completed if the research includes any material from the select agents and toxins list or other potential toxins

Renewal Date of original application approval: __________________________________ Checking this box indicates that you are renewing a previously approved authorization. All renewal applications must include original attachments (vector maps, descriptions of protocols and research scope). They must also include an updated Exposure Control Plan. Please check the box below if you have amended the authorization prior to renewal.

I have amended this application prior to its renewal. List amendment #’s: ___________________

Biological research that requires Institutional Biosafety Committee approval must not proceed until that approval has been granted. Approvals are granted for three years however, if there are any changes in the approved protocol e.g., change of agent (use of a new agent not already covered in the Biological Research Authorization), change of personnel, change of location, please contact the Biological Safety Officer immediately as you may need to submit an amendment or update the Exposure Control Plan.

Brown University Environmental Health and Safety Page 1Created: December 2012 Reviewed: February 2013BSO-1


Please contact with any Biological Safety Officerquestions and return electronic Office of Environmental Health & Safetycopy of the form to: Box 1914

401-863-3087

Please refer to the IBC Policy at http://www.brown.edu/Administration/EHS/biological/ ▲For EH&S Use Only ▲Principal Investigator (Last Name, First Name) Campus Box #:

Academic Title: Email address:

Department: Lab Location Building/Room: (list all Rooms):

Office Location: List all spaces in which the biological materials for this project will be used e.g. shared lab, core facilities, microscope room, animal housing etc. (list all shared spaces and responsible person for each):

Have the responsible parties for shared laboratory spaces/core facilities/housing/equipment rooms sent a copy of the letter of approval (page 3.) to the Biological Safety Officer? YES NOList all personnel outside of your research group who may be impacted by the presence of your biological materials e.g. custodians in rooms where rabies vector species are housed etc.

Office Phone #: Lab Phone #:

Laboratory Supervisor (if not PI) Printed Name and Approval Signature:

Faculty Mentor/Experienced Collaborator (if applicable):

Project Title:

Project Start Date: Project Duration:

Indicate Type of Laboratory: Teaching Research Clinical Environmental Biological Safety Cabinet or other enclosure? Yes(location, type and certification date)______________________________ NoHighest Biosafety Level Required: BSL-1 BSL-2 BSL-3 BSL-4Repository Location (e.g. -80 Freezer): _________________________________

Please list all faculty, employees, and students involved in the project who will come in contact with these materials (Please note: A safety training review will be conducted as part of the IBC review of this application. Please ensure all personnel are up-to-date on required safety training.)

Name and TitleRelevant Experience

(How many years? What kind of Relevant Experience? Example: 4 years experience in tissue culture and transfecting mammalian cells

Department Telephone


IBC # __________ Date ____________

Action __________________________

http://www.brown.edu/Administration/EHS/biological/


This form letter must be electronically signed by the PI listed on page 2 with whom you share lab/storage space, housing (when applicable) or equipment. Please send to all applicable PI’s. Once signed, this form must be emailed to you (the Biological Research Authorization applicant) and forwarded to the Biological Safety Officer or emailed directly to the Biological Safety Officer.

Dear Members of the Brown Institutional Biosafety Committee (IBC),

I have reviewed, evaluated and understand the project entitled: ___________________________________________ submitted to the IBC by: ______________________________________. I believe the information contained in this application is accurate and complete. I agree to abide by the provisions of the application, the Exposure Control Plan (where applicable to my space, equipment or personnel), current NIH Guidelines, the NIH Guide for Grants and Contracts, Brown University policies and procedures, and local, state, and federal regulations.

If I feel that the procedures listed in the application or ECP are not being followed, I will address this issue with the applicant PI and if necessary, the Biological Safety Officer.

I accept responsibility for the safe conduct of this work ONLY as it applies to my space, equipment or personnel. I will ensure that all applicable personnel receive training in regard to proper safety practices and protective equipment needed for this work.

Electronic Signature (Principal Investigator) __________________________________________________ Date: ____________________



I. SYNTHETIC/RECOMBINANT DNA EXPERIMENTS: (Indicate “yes or no” for each question per relevant part [I. and A-D] to determine the section of the NIH Guidelines under which your research falls. Please note: inclusion in one section may exclude your work from another e.g., if your work can best be categorized as fitting under section III-D-4-a of the Guidelines, it won’t likely also fall under sections in III-F). All researchers using synthetic/recombinant nucleic acids must make this determination. )http://oba.od.nih.gov/rdna/nih_guidelines_new.htm YES NO The recombinant or synthetic nucleic acid molecules in your experiment can neither replicate nor generate nucleic acids that can replicate in any living cell (e.g., oligonucleotides or other synthetic nucleic acids that do not contain an origin of replication or contain elements known to interact with either DNA or RNA polymerase), and (2) are not designed to integrate into DNA, and (3) do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight. If yes, the molecules meet all 3 of the above criteria e.g., “they can neither replicate…” or “are not designed to integrate…” or “do not produce a toxin…” , your research is categorized under section III-F-1 of the NIH Guidelines.

Are the recombinant or synthetic nucleic acid molecules in your experiment in organisms, cells , or viruses or have they been modified or manipulated (e.g., encapsulated into synthetic or natural vehicles) to render them capable of penetrating cellular membranes.? If no, your research is categorized under III-F-2 of the NIH Guidelines.

Do the recombinant or synthetic nucleic acid molecules in your experiment consist solely of the exact recombinant or synthetic nucleic acid sequence from a single source that exists contemporaneously in nature? If yes, your research is categorized under section III-F-3 of the NIH Guidelines.

Do the recombinant or synthetic nucleic acid molecules in your experiment consist entirely of nucleic acids from a prokaryotic host, including its indigenous plasmids or viruses when propagated only in that host (or a closely related strain of the same species), or when transferred to another host by well established physiological means? If yes, your research is categorized under III-F-4 of the NIH Guidelines.

Do the recombinant or synthetic nucleic acid molecules in your experiment consist entirely of nucleic acids from a eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain of the same species)? If yes, your research is categorized under III-F-5 of the NIH Guidelines.

Do the recombinant or synthetic nucleic acid molecules in your experiment consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent? See Appendices A-I through A-VI, Exemptions Under Section III-F-6— Sublists of Natural Exchangers, for a list of natural exchangers that are exempt from the NIH Guidelines. If yes, your research is categorized under III-F-6 of the NIH Guidelines.

Does your experiment involve the use of genomic DNA molecules that have acquired a transposable element, provided the transposable element does not contain any recombinant and/or synthetic DNA? If yes, your research is categorized under III-F-7 of the NIH Guidelines.

Do the recombinant or synthetic nucleic acid molecules in your experiment present a significant risk to health or the environment (see Section IV-C-1-b- (1)-(c) as determined by the NIH Director, with the advice of the RAC, and following appropriate notice and opportunity for public comment) NOR fall under any other sections of the NIH Guidelines? See Appendix C, Exemptions under Section III-F-8 for other classes of experiments which are exempt from the NIH Guidelines. If your experiment does not pose a significant risk to health or the environment AS DETERMINED BY THE NIH DIRECTOR ETC., your research is categorized under III-F-8 of the NIH Guidelines after approval from NIH/RAC. If your research does not pose a significant risk to health or the environment AND has NOT been reviewed by the NIH Director, leave this question blank.

Does your research involve breeding two different transgenic rodents or a transgenic rodent and a non-transgenic rodent with the intent of creating a new strain of transgenic rodent that can be housed at BL1 containment AND (1) Both parental rodents can be housed under BL1 containment; and (2) neither parental transgenic rodent contains the following genetic modifications: (i) incorporation of more than one-half of the genome of an exogenous eukaryotic virus from a single family of viruses; or (ii) incorporation of a transgene that is under the control of a gammaretroviral long terminal repeat (LTR); and (3) the transgenic rodent that results from this breeding is not expected to contain more than one-half of an exogenous viral genome from a single family of viruses? If yes, this procedure is categorized under Appendix C-VIII of the NIH Guidelines.

A. TISSUE CULTURE EXPERIMENTS INVOLVING SYNTHETIC/RECOMBINANT DNA

YES NO Do the recombinant or synthetic nucleic acid molecules in your experiment that are propagated and maintained in cells in tissue culture contain less than one-half of any eukaryotic viral genome (all viruses from a single family being considered


http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Toc351276324


http://oba.od.nih.gov/rdna/nih_guidelines_new.htm#_APPENDIX_C._EXEMPTIONS

http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Section_IV-C-1-b-(1)._Major



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http://oba.od.nih.gov/rdna/nih_guidelines_new.htm


identical – see Appendix C-IX-E, Footnotes and References of Appendix C)? If yes, your research is categorized under Appendix C-1 of the NIH Guidelines.

Do any recombinant or synthetic nucleic acid experiments involve Risk Groups 3, 4 or restricted organisms or nucleic acids from Risk Groups 3, 4 or restricted organisms? If no, your research is categorized under Appendix C-1 of the NIH Guidelines.

Do any recombinant or synthetic nucleic acid experiments involve introduction of genes coding for molecules toxic for vertebrates? If no, your research is categorized under Appendix C-1 of the NIH Guidelines.

Do any recombinant or synthetic nucleic acid experiments involve infectious viruses? If no, research is categorized under Appendix C-1 of the NIH Guidelines

Do any recombinant or synthetic nucleic acid experiments involve defective viruses in the presence of helper viruses? If no, your research is categorized under Appendix C-1 of the NIH Guidelines.

Do any recombinant or synthetic nucleic acid experiments involve whole plants regenerated from plant cells and tissue cultures? If yes AND they remain axenic cultures even though they differentiate into embryonic tissue and regenerate into plantlets, your research is categorized under Appendix C-1 of the NIH Guidelines.

B. EXPERIMENTS INVOLVING E.COLI K-12, YEAST, KLUYVEROMYCES LACTIS BACILLUS SUBTILIS/LICHENIFORMIS HOST- VECTOR SYSTEMS

YES NO Do any experiments involve Risk Groups 3, 4 or restricted organisms or nucleic acids from Risk Groups 3, 4 or restricted organisms? If no, your research is categorized under Appendix C-II (for E. coli K-12) or Appendix C-III (for Saccharomyces cerevisiae and Saccharomyces uvarum), Appendix C-IV (for Kluyveromyces lactis) or Appendix C-V (for Bacillus subtilis/licheniformis).

Do any experiments involve introduction of genes coding for molecules toxic for vertebrates? If no, your research is categorized under Appendix C- II (for E. coli K-12) or Appendix C-III (for Saccharomyces cerevisiae and Saccharomyces uvarum), Appendix C-IV (for Kluyveromyces lactis or Appendix C-V (for Bacillus subtilis/licheniformis).. Will there be any large-scale experiments (more than 10 L of culture)? If no, your research is categorized under Appendix C- II (for E. coli K-12) or Appendix C-III (for Saccharomyces cerevisiae and Saccharomyces uvarum), Appendix C-IV (for Kluyveromyces lactis) or Appendix C-V (for Bacillus subtilis/licheniformis).

If using asporogenic Bacillus subtilis or asporogenic Bacillus licheniformis, are you using a strain which does not revert to a spore-former with a frequency greater than 10-7? If yes, your research is categorized under Appendix C-V (for Bacillus subtilis/licheniformis).

C. SYNTHETIC/RECOMBINANT DNA EXPERIMENTS THAT REQUIRE IBC APPROVAL AND DO NOT FALL INTO THE ABOVE SECTIONS

YES NO Is any human or animal pathogen (defined as a Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents) used as either the host organism or as a vector? If yes, your research is categorized under III-D-1 of the NIH Guidelines.

Is any recombinant or synthetic nucleic acid molecules from Risk Group 2, Risk Group 3, Risk Group 4 or restricted agents cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems? If yes, your research is categorized under III-D-2 of the NIH Guideilnes.. Do recombinant or synthetic nucleic acid or RNA experiments involve the use of infectious DNA or RNA Viruses or Defective DNA or RNA Viruses in the Presence of Helper Virus in Tissue Culture Systems? If yes, your research is categorized under III-D-3 of the NIH Guidelines.

Do recombinant or synthetic nucleic acid or RNA experiments involve the use of defective animal or plant viruses in the presence of helper virus in tissue culture systems? If yes, your research is categorized under III-D-3 of the NIH Guidelines.

Do recombinant or synthetic nucleic acid or RNA experiments involve whole animals (Section III-D-4) or plants (Section III-D- 5)? Indicate which________________ .

Do experiments involve more than 10 liters of culture? If yes, your research is categorized under III-D-6 of the NIH Guidelines.

Do experiments involve influenza viruses generated by recombinant or synthetic methods (e.g., generation by reverse genetics of chimeric viruses with reassorted segments, introduction of specific mutations)? If yes, your research is categorized






























http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Appendix_C-VIII._Footnotes


under III-D-7of the NIH Guidelines.

Do experiments NOT fall under sections III-A, III-B, III-C, III-D, III-F of the NIH Guidelines AND involve the formation of recombinant or synthetic nucleic acid molecules containing no more than two-thirds of the genome of any eukaryotic virus? If yes, your research is categorized under III-E-1 of the NIH Guidelines.

Do experiments NOT fall under sections III-A, III-B, III-C, III-D, III-F of the NIH Guidelines AND involve nucleic acid molecule-modified whole plants, and/or experiments involving recombinant or synthetic nucleic acid molecule-modified organisms associated with whole plants? If yes, your research is categorized under III-E-2 of the NIH Guidelines.

Do experiments NOT fall under section III-D-4 and involve the generation of rodents in which the animal's genome has been altered by stable introduction of recombinant or synthetic nucleic acid molecules, or nucleic acids derived therefrom, into the germ-line (transgenic rodents)but can be conducted at BSL-1? If yes, your research is categorized under III-E-3-a of the NIH Guidelines.

D. EXPERIMENTS THAT REQUIRE IBC, RAC REVIEW AND NIH DIRECTOR APPROVAL BEFORE INITIATION (III-A), EXPERIMENTS THAT REQUIRE NIH/OBA AND IBC APPROVAL BEFORE INITIATION (III-B), AND EXPERIMENTS THAT REQUIRE IRB AND IBC APPROVAL AND NIH/OBA REGISTRATION BEFORE INITIATION APPROVAL BEFORE INITIATION (III-C)

YES NO Does the research involve the transfer of drug resistance trait to an organism that does not acquire it normally (if it could compromise the use of the drug to control disease agents in humans, animal or agriculture) ? If yes, your research is categorized under III-A-1 of the NIH Guidelines.

Does the experiment involve the formation of recombinant or synthetic nucleic acid containing genes coding for the synthesis of molecules toxic for vertebrates? If yes, your research is categorized under III-B-1 of the NIH Guidelines.. Does the experiment involve human gene transfer experiments? If yes, your research is categorized under III-C-1 of the NIH Guidelines.

E. Describe below, specific host(s), vector(s), DNA(s) and what proteins will be produced? (NOTE: Recombinant/synthetic nucleic acid molecules work that falls under any of the III-F sections or Appendices CI-CVIII excluding excepted paragraphs A, need not be described here and you may skip directly to part F of this section. Otherwise, please complete.)

Host Cells:_________________________________________________________________________________________________ __________________________________________________________________________________________________________ __________________________________________________________________________________________________________

Vector(s): _________________________________________________________________________________________________ __________________________________________________________________________________________________________ ___________________________________________________________________________________________________________ Inserted DNA/Synthetic Nucleic Acid Molecule: __________________________________________________________________________________________________________ __________________________________________________________________________________________________________ ___________________________________________________________________________________________________________ ___________________________________________________________________________________________________________

Protein produced (if applicable):________________________________________________________________________________ ____________________________________________________________________________________________________________ ____________________________________________________________________________________________________________

THE EXPERIMENTS IN THIS AUTHORIZATION CAN BE CATEGORIZED UNDER NIH GUIDELINES SECTION(S)(list all that apply):_____________________________________________________________________________________

F. Can your experiment or part of your experiment be listed under sections III-A, III-B, III-C, III-D, III-E-1 or III-E-2 of the NIH Guidelines? Yes If yes, complete parts G and H of this application. If your project includes experiments that fall under sections III-A, III-B, III-C, III-D, III-E-1, III-E-2 AND III-F, III-E-3a or Appendices CI-CVIII OF NIH Guidelines, complete parts G and H of this application. No If no, a.) Describe why your research (or part of your research) fits into section III-F, III-E-3a or Appendices CI-CVIII of the NIH Guidelines and provide a brief summary of your research.










http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Section_III-F._Exempt

http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Section_III-D._Experiments

http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Section_III-C._Experiments

http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Section_III-B._Experiments

http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Section_III-A._Experiments


http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Section_III-F._Exempt

http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Section_III-D._Experiments

http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Section_III-C._Experiments

http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Section_III-B._Experiments

http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Section_III-A._Experiments



b.) Describe key features of any key features cell line, virus or bacteria used in this project and if the experiments will result in acquisition of new characteristics e.g., enhanced virulence, infectivity, drug resistance, or change in host range. Give references if appropriate.

c.) Describe the source of the DNA/synthetic nucleic acid molecules, the nature of the inserted DNA/synthetic nucleic acid molecules sequences, the host(s) and vector(s) to be used, if an attempt will be made to obtain expression of a foreign gene and what protein will be produced. Be sure to account for whether or not the genes involved or expressed have potential: toxicity, allergenicity or other risk to research personnel

d.) Percent of the pathogen genome present in the vector (kilobases of the parent pathogen in the vector and packaging cell combined). e.) Outline the general procedures and techniques that will be employed e.g., cell culture, bacterial culture, DNA isolation. f.) Complete a copy of the Exposure Control Plan (page 13). ____________________________________________________________________________________________________ _____________________________________________________________________________________________________ _____________________________________________________________________________________________________ ______________________________________________________________ INCLUDE AS ATTACHMENT IF NECESSARY

G. If your experiment or part of your experiment can be listed under sections III-A, III-B, III-C, III-D, III-E-1 or III-E-2 of the NIH Guidelines, please complete the following fields. In submitting this application, you agree to understand and comply with the Principal Investigator responsibilities outlined in section IV-B-7 of the NIH Guidelines found here: http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Toc7261589

i. Provide a brief summary of your research involving recombinant or synthetic nucleic acid molecules in non-technical language INCLUDE AS ATTACHMENT IF NECESSARY:________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________.

ii. Will the experiment be carried out in E. coli or other prokaryotic host? Yes No If yes, specify: _________________________________________________________________________________________ Host strains: ___________________________________________________________________________________________ Vectors: _______________________________________________________________________________________________ Inserted DNA/synthetic nucleic acid molecules (include names of genes and organisms from which they were cloned): _______________________________________________________________________________________________________ Will whole virus or provirus be cloned? Yes No NIH Guideline Section: _________________________ Recommended Biosafety Level: __________________________

iii. Will the experiment be carried out in eukaryotic cells? Yes No If yes, specify: _________________________________________________________________________________________ Host strains: ___________________________________________________________________________________________ Vectors: _______________________________________________________________________________________________ Inserted DNA/synthetic nucleic acid molecules: _______________________________________________________________________________________________________ Helper virus or packaging cells if used: ____________________________________________________________________ What fraction of a eukaryotic viral genome is contained in the recombinant DNA molecules (including vector and insert)? <1/2 >1/2 but <2/3 >2/3 NIH Guidelines Section: _________________________ Recommended Biosafety Level: __________________________

iv. Will the experiment be carried out using whole plants or animals as hosts? Yes NoIf yes, specify: _________________________________________________________________________________________ Host strains: ___________________________________________________________________________________________ Vectors: _______________________________________________________________________________________________ Inserted DNA/synthetic nucleic acid molecules: ______________________________________________________________ ________________________________________________________________________________________________________ Helper virus or packaging cells if used: ____________________________________________________________________ What fraction of a eukaryotic viral genome is contained in the recombinant DNA/synthetic nucleic acid molecule? <2/3 >2/3

NIH Guidelines Section: _________________________ Recommended Biosafety Level: __________________________

v. Will any of the sequences code for toxins? Yes (LD50)__________ Novi. Will VSV-G be used for pseudotyping and are you aware that this can increase the risk of exposure through absorption and

inhalation along with injection and ingestion? Yes Novii. If using adeno or lentivirus, will you be using third or fourth generation systems for safety? Yes Noviii. If using oncogene inserts, a DNA sequencing library shall be kept. Indicate the location of these

records____________________________


http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm%23_Toc7261589


H. SPECIFIC NUCLEIC ACID INFORMATIONa.) Describe the source of the DNA/synthetic nucleic acid molecules, the nature of the inserted DNA/synthetic nucleic acid molecules sequences, the host(s) and vector(s) to be used, if an attempt will be made to obtain expression of a foreign gene and what protein will be produced. Be sure to account for whether or not the genes involved or expressed have potential: toxicity, allergenicity or other risk to research personnelb.) Attach vector maps c.)Describe key features of the agent, virus or bacteria used in this project and if the experiments will result in acquisition of new characteristics e.g., enhanced virulence, infectivity, drug resistance, or change in host range. Give references if appropriate.

d.) Percent of the pathogen genome present in the vector (kilobases of the parent pathogen in thevector and packaging cell combined). e.) Will the research involve the use of antibiotic selection markers? Yes No If yes, list the markers and microbial agents used (e.g. neomycin resistance marker in E. coli)

f.) Complete a copy of the Exposure Control Plan (page 13). INCLUDE AS ATTACHMENT IF NECESSARY_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

II. MICROORGANISMS

Agent (genus and species) Strain Hum

an Pathogen

Opportunis

tic Hum

an Pathogen

Anim

al Pathogen

Plant Pathogen

Non-

Pathogenic

Other

BSL-1,2, 2+

Building & Room agent is used or stored (indicate which) ex. SFH 229 stored

Biosafety Cabinet make, model and Certification Date

A. Is there a baseline serological test, vaccine, therapeutic treatment or post-exposure prophylaxis/plan (PEP) available should someone in the lab become exposed (If several microorganisms are indicated above, please list vaccine, therapeutic treatment, or PEP for each. The details of the PEP should be included in the Exposure Control Plan document)?________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________.

Answer the questions below per microorganism if using multiple microorganisms.

B. Do you work with quantities greater than 1 liter? Yes (microorganism)_____________, largest volume _________ No

C. Do you inactivate the agent/material prior to other laboratory manipulations? Yes (microorganism) ______________ No If yes, select method: Heat ______________ Chemical _____________ Radiation____________ Other_____________

D. Do you concentrate the material? Yes (microorganism) ______________ No If yes, select method: Centrifuge___________ Filtration ____________ Precipitation____________ Other_________

E. Do you insert the agent into intact animals? Yes, which microorganism/ animal species________________________ No IACUC Approval? Yes, number___________________ No Pending

F. If agent inserted into animal is a virus or viral vector, indicate the shedding period (if multiple, specify shedding period for each). ________________________________________________________________________________________________

G. Will this project at any time involve shipping biological materials over public thoroughfares or transporting between two Brown University owned or affiliated facilities? No Yes, explain _______________________________________________________________________________________________________________________________________________________________________.

H. Does the research involve human subjects or human products? No Yes N/A Commercial Cell Lines



IRB Approval? Yes, number___________________ No Pending N/A

I. If you have not provided the following details from section I. Recombinant DNA Experiments, please complete the following: Provide a brief summary of your research (nature and purpose): I have answered this question previously ______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________INCLUDE AS ATTACHMENT IF NECESSARY.

J. If you have not provided the following details from section I. Recombinant DNA Experiments, please complete the following:

a.) Describe the nature of the host(s) and vector(s) to be used. b.)Describe key features of the agent, virus or bacteria used in this project and if the experiments will result in acquisition

of new characteristics e.g., enhanced virulence, infectivity, drug resistance, or change in host range. Give references if appropriate.

c.) Outline the general procedures and techniques that will be employed e.g., cell culture, bacterial culture, DNA isolation.

d.) Complete a copy of the Exposure Control Plan (page 13). I have answered this question previously _____________________________________________________________________________________________________ _____________________________________________________________________________________________________ _____________________________________________________________________________________________________ _____________________________________________________________________________________________________ _______________________________________________________________ INCLUDE AS ATTACHMENT IF NECESSARY

III. HUMAN/NON-HUMAN PRIMATE MATERIALS ALL Human/Non-Human Primate Materials require BSL-2 unless fixed or embedded.

A. Human Materials/NHP MaterialsHuman/NHP Material Type and Source All Buildings and Rooms where used/stored

Blood

Body Fluids

Organs

Tissues

B. Tissue CulturePrimary Cell Lines/ Continuous Cell Lines

(indicate which) Type and Source All Buildings and Rooms where used/stored

C. Transplantable tumorsTumor/Description Type and Source Animal or Tissue Culture All Buildings and Rooms where used/stored

D. HybridomaCarrier cell line In vivo/In vitro Animal Used All Buildings and Rooms where used/stored



E. Is there a baseline serological test, vaccine, therapeutic treatment or post-exposure prophylaxis/plan (PEP) available should someone in the lab become exposed (If several microorganisms are indicated above, please list vaccine, therapeutic treatment, or PEP for each. The details of the PEP should be included in the Exposure Control Plan document)?_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

F. Do you work with quantities greater than 1 liter? Yes (human material)_____________, largest volume ________ No G. Do you concentrate the material? Yes (microorganism) ______________ No

If yes, select method: Centrifuge___________ Filtration ____________ Precipitation____________ Other_________H. Do you insert the material into intact animals? Yes, which microorganism/ animal species_____________________ No

IACUC Approval? Yes, number___________________ No PendingI. Will this project at any time involve shipping biological materials over public thoroughfares or transporting between two Brown

University owned or affiliated facilities? No Yes, explain I have answered this question previouslyJ. ___________________________________________________________________________________________________________________

________________________________________________________________________________________________________________________________________________________________________________________________________________________________

K. Does the research involve human subjects or human products? No Yes N/A Commercial Cell Line I have answered this question previously

IRB Approval? Yes, number___________________ No Pending N/A

L. If you have not provided the following details from section I. Recombinant DNA Experiments, or section II. Microorganisms, please complete the following:Provide a brief summary of your research (nature and purpose): I have answered this question previously____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ INCLUDE AS ATTACHMENT IF NECESSARY.

M. If you have not provided the following details from section I. Recombinant DNA Experiments, or section II. Microorganisms, please complete the following:

a.) Describe the nature of the human material(s), host(s) and vector(s) to be used. b.)Describe key features of the human material, virus or bacteria used in this project and if the experiments will result in acquisition of new characteristics e.g., enhanced virulence, infectivity, drug resistance, or change in host range. Give references if appropriate. c.) Outline the general procedures and techniques that will be employed e.g., cell culture, bacterial culture, DNA isolation. d.) Complete a copy of the Exposure Control Plan (page 13). I have answered this question previously _____________________________________________________________________________________________________ _____________________________________________________________________________________________________ _______________________________________________________________ INCLUDE AS ATTACHMENT IF NECESSARY .

IV. ANIMALS, ARTHROPODS, INSECTS OR PLANTS

A. Animal/Arthropod/Insect/Plant

Animal/Arthropod/Insect/Plant (Genus

species)

USDA, USFW, CDC Permit Applicable

only for capture/transport (indicate which)

Biosafety Level (BSL-#), Animal Biosafety

Level(ABSL-#), Plant Biosafety Level (BL#-P)

For containment

Transgenic or Creating

TransgenicIf yes, please make

sure this is represented in section I of this

form

Screened for

pathogens prior to arrival?

All Buildings and Rooms

where used/stored



B. Tissue CultureCell Line Type and Source Biosafety Level All Buildings and Rooms where used/stored

C. Transplantable tumors

Tumor/Description Type and Source Animal or Tissue Culture Biosafety Level All Buildings and Rooms where used/stored

D. Hybridoma

Carrier cell line In vivo/In vitro Animal Used Biosafety Level All Buildings and Rooms where used/stored

Do not complete the section below if you’ve already answered these questions for Non-Human Primates in section III.

E. Is there a baseline serological test, vaccine, therapeutic treatment or post-exposure prophylaxis/plan (PEP) available should someone in the lab become exposed (If several microorganisms are indicated above, please list vaccine, therapeutic treatment, or PEP for each. The details of the PEP should be included in the Exposure Control Plan document, page 13)?________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Do you work with quantities greater than 1 liter? Yes (material type)_____________, largest volume _____________ No

F. Do you concentrate the material? Yes (material type) ______________ No

If yes, select method: Centrifuge___________ Filtration ___________ Precipitation____________ Other_________G. Do you insert the material into intact animals? Yes, which microorganism/ animal species_____________________ No

IACUC Approval? Yes, number___________________ No PendingH. Will this project at any time involve shipping biological materials over public thoroughfares or transporting between two Brown

University owned or affiliated facilities? No Yes, explain (You may skip this question if you have answered in a previous section)______________________________________________________________________________________________________________________________________________________________________________________________________________________

I. Does the research involve human subjects or human products? No Yes N/A Commercial Cell Lines (You may skip this question if you have answered in a previous section)

IRB Approval? Yes, number___________________ No Pending

J. If you have not provided the following details in section I. Recombinant DNA Experiments, section II. Microorganisms, or section III. Human Materials please complete the following:Provide a brief summary of your research (nature and purpose): I have answered this question previously _____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ INCLUDE AS ATTACHMENT IF NECESSARY.

K. If you have not provided the following details in section I. Recombinant DNA Experiments, section II. Microorganisms, or section III. Human Materials please complete the following:

a.) Describe the nature of the biological material(s), host(s) and vector(s) to be used. b.) Describe key features of the biological material, virus or bacteria used in this project and if the experiments will result in



acquisition of new characteristics e.g., enhanced virulence, infectivity, drug resistance, or change in host range. Give references if appropriate. c.) Outline the general procedures and techniques that will be employed e.g., cell culture, bacterial culture, DNA isolation. d.) Complete a copy of the Exposure Control Plan (page 13). I have answered this question previously _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________

_______________________________________________________________________ INCLUDE AS ATTACHMENT IF NECESSARY

V. Biological Toxins and Select Agents (For more information on the Select Agents and Toxins Program e.g., list of agents, regulatory limits etc., please visit the following URL: http://www.selectagents.gov/)

A. Biological Toxins and Select Agents

Type of Toxin/Select

AgentTotal Amount in

Lab/SupplierExperimental Concentration

Toxin LD50 Biosafety Level (BSL)

Inactivation Protocol

Prepared?All Buildings and Rooms

where used/StoredHuman Animal

Ex:Tetrodotoxin 2mg/ Sigma 0.05 m 334g/kg .334 mg/kg

2 Yes See attachment

SFH 887

B. Is there a baseline serological test, vaccine, therapeutic treatment or post-exposure prophylaxis/plan (PEP) available should someone in the lab become exposed (If several agents/toxins are indicated above, please list vaccine, therapeutic treatment, or PEP for each. The details of the PEP should be included in the Exposure Control Plan document)?________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

B. Do you work with quantities greater than 1 liter? Yes (material type)_____________, largest volume _______________ No

C. Do you concentrate the material? Yes (material type) ______________ No If yes, select method: Centrifuge___________ Filtration ___________ Precipitation____________ Other_________

D. Do you insert the material into intact animals? Yes, which microorganism/ animal species_____________________ No IACUC Approval? Yes, number___________________ No Pending

E. Will this project at any time involve shipping biological toxins/select agents over public thoroughfares or transporting between two Brown University owned or affiliated facilities? No Yes, explain (You may skip this question if you have answered in a previous section)____________________________________________________________________________________________________________________________________________________________________________________________________________________Does the research involve human subjects or human products? No Yes N/A Commercial Cell Lines I have answered this question previously

F. IRB Approval? Yes, number___________________ No Pending

G. If you have not provided the following details in section I. Recombinant DNA Experiments, section II. Microorganisms, section III. Human Materials or section IV. Animals, Arthropods, Insects or Plants please complete the following: Provide a brief summary of your research (nature and purpose): I have answered this question previously______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________.

H. If you have not provided the following details in section I. Recombinant DNA Experiments, section II. Microorganisms, section III. Human Materials or section IV. Animals, Arthropods, Insects or Plants please complete the following:

a.) Describe the nature of the biological toxin(s)/select agent(s), host(s) and vector(s) to be used. b.)Describe key features of the biological toxin/select agent, virus or bacteria used in this project and if the experiments will result in acquisition of new characteristics e.g., enhanced virulence, infectivity, drug resistance, or change in host range.


http://www.selectagents.gov/


Give references if appropriate. c.) Outline the general procedures and techniques that will be employed e.g., cell culture, bacterial culture, DNA isolation. d.) Complete a copy of the Exposure Control Plan ([age 13). I have answered this question previously _____________________________________________________________________________________________________ _____________________________________________________________________________________________________ _____________________________________________________________________________________________________

________________________________________________________________INCLUDE AS ATTACHMENT IF NECESSARY .The application form (summary and any attachments) must provide sufficient detail for the Biological Safety Committee to understand and evaluate components of the project in order to review the application. For attached published references, please highlight pertinent paragraphs or sentences. Submissions that lack detail or are illegible will be deferred from action and returned for revision and resubmission. Incomplete applications may be delayed.

Certification and Signature

The information contained in this application is accurate and complete. I am familiar with and agree to abide by the provisions of the current NIH Guidelines, the NIH Guide for Grants and Contracts, Brown University policies and procedures, and local, state, and federal regulations.

In addition, I agree to abide by the following requirements:

a. I will initiate no recombinant or synthetic nucleic acid molecule research subject to the NIH Guidelines until that research has been reviewed by the Biological Safety Committee.

b. I will follow appropriate biosafety level laboratory techniques in the research.c. I will comply with all shipping requirements for recombinant or synthetic nucleic acid materials.d. I will make available to the laboratory staff copies of the approved protocols that describe the potential

biohazards and the precautions to be taken.e. I will have a specific protocol in place for post-exposure prophylaxis and/or treatment and my laboratory

personnel will know it’s location and have access to this document at all times.f. I will train the laboratory staff in good microbiological practices and techniques required to ensure safety for

this project, in the procedures for dealing with accidents, and in waste management procedures, prior to any project work and at least annually thereafter.

g. I will ensure that all laboratory staff are listed with the Office of Environmental Health & Safety.h. I will submit in writing a request for approval from the Biological Safety Committee for any significant

modifications to the study, facilities, or procedures.i. I will supervise staff, and correct work errors and conditions that could result in breach of the NIH Guidelines

or Brown University policy.j. I will submit to the Biosafety Officer, the Biological Safety Committee, and the Office of Recombinant DNA

Activities at NIH (if applicable), reports of any research related accident, exposure incident, release of recombinant or synthetic nucleic acid molecules to the environment, problems pertaining to the implementation of biological and physical containment procedures, or violations of the NIH Guidelines

k. I have read and understood the United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (DURC) http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=2&ved=0CDQQFjAB&url=http%3A%2F%2Foba.od.nih.gov%2Foba%2Fbiosecurity%2FPDF%2FUnited_States_Government_Policy_for_Oversight_of_DURC_FINAL_version_032812.pdf&ei=KkMzUuLAD8-u4APYm4HgAw&usg=AFQjCNFjinfNI2PPtgpyrA4bKJ3rCgKCug&bvm=bv.52164340,d.dmg I have notified the Institutional Biosafety Committee (IBC) and the Biological Safety Officer as to the applicability of this program to my research.

Please identify either yourself or another individual who has significant and appropriate microbiological education and experience to conduct the work at the biosafety level requested and with the biohazards identified.

Circle one: Self Other ____________________________________________Name of Identified Individual

Signature _________________________________________ Electronic Signature of Identified Individual


http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=2&ved=0CDQQFjAB&url=http%3A%2F%2Foba.od.nih.gov%2Foba%2Fbiosecurity%2FPDF%2FUnited_States_Government_Policy_for_Oversight_of_DURC_FINAL_version_032812.pdf&ei=KkMzUuLAD8-u4APYm4HgAw&usg=AFQjCNFjinfNI2PPtgpyrA4bKJ3rCgKCug&bvm=bv.52164340,d.dmg




As Principal Investigator, I accept responsibility for the safe conduct of work with this material. I will ensure that all personnel receive training in regard to proper safety practices and protective equipment needed for this work.

Electronic Signature (Principal Investigator) __________________________________________________ Date: ___________

Exposure Control Plan

Brown University’s Institutional Biosafety Committee, along with the Office of Environmental Health and Safety, has developed a template Exposure Control Plan (ECP) for all Biological Research Authorizations and Biological Safety Manuals.

The Laboratory Supervisor must read the ECP template and carefully fill out key components specific to the protocol in which it belongs. In some cases one ECP may be thorough enough to be used for more than one protocol however, ALL ECP’s involving the use of human/non-human primate blood, cells, tissues, or bodily fluid must be reviewed and updated annually. All other ECP’s must be reviewed and updated when necessary (i.e., a change of agent, procedure, location, or staff). It is the responsibility of the PI to ensure that all personnel who will be working on the protocol are listed on the application and in the ECP and that they complete all of the required Brown University EHS safety training.

Please contact Brown University’s Biological Safety Officer for assistance at 401-863-3353.



Exposure Control Plan (ECP)

POLICY

Brown University is committed to providing a safe and healthful work environment for faculty, students, and staff. In pursuit of this goal, the following Exposure Control Plan (ECP) is provided to assist researchers in developing procedures to eliminate or minimize occupational exposure to biological hazards and bloodborne pathogens in accordance with the Institutional Biosafety Committee (IBC) and OSHA standards. This ECP includes:

Determination of researcher exposure Implementation of various methods of exposure control, including:

Universal precautions Engineering and administrative controls Personal protective equipment Hepatitis B vaccination Disinfection/sterilization Housekeeping Post-exposure evaluation and follow-up Recordkeeping Communication of hazards to visitors/contractors and training

Implementation methods for these elements of the standard are discussed in the subsequent pages of this ECP.

Please Note: Where biological research is conducted with hazardous chemicals, the Chemical Hygiene Plan, Chemical Safety Protocols and Lab Safety Manual shall be used according to the policies discussed in Laboratory Safety Training.

PROGRAM ADMINISTRATION

The Laboratory Supervisor (listed below) is responsible for implementation of the ECP in location(s) covered by the plan, will maintain, review and update the ECP at least annually, and whenever necessary to include new or modified tasks and procedures.

Laboratory Supervisor Name/Research Location:

Title of the protocol covered by this ECP:

IBC Authorization number of the protocol covered by this ECP:Contact Number (include area code):

24-Hour Contact Number (mobile/home):



RESEARCHER EXPOSURE DETERMINATION

The following is a list of all laboratory personnel who perform tasks and procedures in which occupational exposure may occur and who must comply with all provisions outlined in this Exposure Control Plan.

Name/Job Title (example: John Smith, Research Asst.)

Department/Laboratory Location (example: MCB/BMC 864)

Task/Procedure where occupational exposure may occur (example: Cell injection in live mice)

METHODS OF IMPLEMENTATION AND CONTROL

Universal Precautions

Universal Precautions is an approach to infection control. According to the concept of Universal Precautions, all human blood and other potentially infectious material (OPIM) such as certain human body fluids are treated as if known to be infectious for HIV, HBV, and other bloodborne pathogens.

Even when working with biological substances believed not to be infectious, researchers shall use universal precautions.

Exposure Control Plan Training

In addition to completion of Brown University EHS Biological Safety Training and Bloodborne Pathogen (BBP) Training, researchers shall read and understand the specific ECP for the protocol on which they are assigned.

Engineering Controls and Administrative Controls

Engineering controls and administrative controls will be used to prevent or minimize exposure to biological materials and bloodborne pathogens. Whenever possible, select and utilize engineering controls and administrative controls that mitigate exposure such as, but not limited to:

Appropriate Biosafety Cabinets Non-glass capillary tubes Sharps with Engineered Sharps Injury Protections (SESIP’s) Needleless systems Personal protective equipment

Administrative controls are defined as: controlling workplace hazards through methods such as training, written operating procedures, work permits, safe work practices, exposure time limitations, alarms, signs, and warnings. The specific engineering controls and administrative controls used as part of this research protocol are listed below:

Engineering Controls (example: Biosafety Cabinet) Administrative Controls (example: food and drink prohibited in lab)



Sharps containers shall be replaced before they become overfilled to prevent needle sticks. Sharps must fit completely into the selected sharps container (i.e., not to exceed the manufacturers marked "full" line). Do not bend, break, re-cap, or re-sheath any needle. Do not force or push any item into a sharps container. When the fill line is reached, sharps containers must be closed and locked (all sharps containers come with a locking mechanism). Requests for full sharp container pick-up and replacement containers supplied by Environmental Health and Safety can be made through the Container Request form located at the following URL:

http://brown.edu/Administration/EHS/container_disposal/

Personal Protective Equipment (PPE)

Describe below, the appropriate PPE that will be used for specific tasks or procedures. (Examples: Nitrile gloves shall be used for handling specimens preserved in formaldehyde, splash goggles will be worn while performing blood draws on mice etc.) Remember, a minimum level of PPE must be worn in the lab at all times i.e., safety glasses and appropriate clothing.

PPE (example: splash goggles) Task/Procedure (example: worn when pouring liquid nitrogen)

All researchers using PPE must observe the following precautions:

Remove gloves carefully to avoid spraying or spatter Wash hands immediately or as soon as feasible after removing gloves or other PPE. Remove PPE after it becomes contaminated and before leaving the work area For proper disposal of PPE please refer to the Brown University Biological Waste Program found at the following

URL:

http://brown.edu/Administration/EHS/policies/biological_waste_program.pdf

Wear appropriate gloves when it is reasonably anticipated that there may be hand contact with blood or OPIM, and when handling or touching contaminated items or surfaces; replace gloves if torn, punctured or contaminated, or if their ability to function as a barrier is compromised

Never wash or decontaminate disposable gloves for reuse.



http://brown.edu/Administration/EHS/container_disposal/


Wear appropriate face and eye protection when splashes, sprays, spatters, or droplets of blood or OPIM pose a hazard to the eye, nose, or mouth

Remove immediately or as soon as feasible any garment contaminated by blood or OPIM, in such a way as to avoid contact with the outer surface

If utility gloves are being used, dispose if contaminated

Vaccination/Screening Program

Are there any non-routine measures such as special vaccinations or additional health screening techniques that would potentially benefit research staff participating in or supporting this project?

___ No.

___ Yes. If yes, describe________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________.

Please indicate a Post Exposure prophylaxis or treatment if applicable: (e.g., anti-viral medication for certain viral exposures), or if specific procedures are required, describe the Post Exposure Plan (PEP) here:____________________________________________________________________________________________________________________________________________________________________________________________________.

Disinfection and Sterilization

Disinfection and sterilization is important for any biological research or biological waste disposal. To choose an appropriate disinfectant, the identity of the micro-organisms, their concentration and the degree of inactivation desired should be considered. Physical factors such as whether a space or surface is to be decontaminated, the type of surface, and any interaction between the material and potential disinfectants should also be factored in the selection. Time available for disinfection and the time required for particular disinfectants to be effective need to be considered. For clarification, “disinfection” is not sporicidal. A few disinfectants will kill spores with prolonged exposure times (3-12 hours) and are called “chemical sterilants.”

Factors that may affect the efficacy of chemical disinfectants include the following:

Organic and inorganic load present Type and level of microbial contamination Concentration of and exposure time to the germicide Physical nature of the object (e.g., crevices, hinges etc.) Presence of biofilms Temperature and pH of the disinfection process In some cases, relative humidity of the sterilization process

Most disinfectant solutions need to be regularly prepared as fresh solutions to avoid growth of micro-organisms in the solution and to ensure optimum activity of the disinfectant chemical.

Remember to don proper PPE including chemically resistant gloves while performing disinfection.If using commercial disinfectants, Federal law requires all applicable label instructions on EPA-registered products to be followed (e.g., use-dilution, shelf life, storage, material compatibility, safe use, and disposal). If the user selects exposure



conditions (e.g., exposure time) that differ from those on the EPA-registered products label, the user assumes liability for any injuries resulting from off-label use and is potentially subject to enforcement action under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 65.

Disinfection Tool (Table 1):

All University researchers, staff and students listed in this Exposure Control Plan must reference this chart before engaging in a protocol, disposing of, storing, or transporting within a building biological materials in order to understand the specific disinfectants that must be used in the authorization.

Using the Disinfection Tool (Table 1):

For all biological materials, and biological wastes encountered, the users of an Exposure Control Plan must indicate which disinfectant or sterilant they intend to use along with the recommended dilution, contact time, pH and temperature. A reference in which this disinfectant was recommended must be included in the column labeled “REFERENCE.” If using an EPA-registered or commercial product for disinfection/sterilization please also indicate the name of this product along with its recommended dilution, contact time, pH and temperature (in the disinfection table provided). If utilizing steam sterilization, indicate the settings used i.e., time, temperature and pressure. A good resource for this information is the “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008” from the Centers for Disease Control (CDC). To obtain a list of Selected EPA-registered Disinfectants visit:

http://www.epa.gov/oppad001/chemregindex.htm

Attachments to this table may be included.

Spaces within the table that are shaded and marked “NR” refer to disinfectants that were specifically Not Recommended for certain biological materials/wastes by either the CDC, World Health Organization (WHO) and/or the Brown University Institutional Biosafety Committee. For example, the prions category marked with many “NR’s” were shown to have a high innate resistance to many chemical germicides. In fact, proper chemical decontamination for prions as recommended by the WHO include a combination heat and NaOH or for surfaces, by flooding for one hour, with NaOH or sodium hypochlorite, followed by water rinses.

If in the course of your research you find conflicting support for disinfectants/sterilants that have been automatically labeled as “NR” in the Disinfection Tool, please include a reference that indicates your selected disinfectant is effective. It is possible that a product listed as “NR” might be sufficient for the type of disinfection/sterilization you require.

Additionally, when using this tool please consider the exceptions and restrictions listed below.

Exceptions and Restrictions:

Ethanol is not recommended for surface contamination due to the low contact time before evaporation Bleach dilutions made be made fresh daily as the efficacy only last 24 hours Formaldehyde is not a recommended disinfectant due to its carcinogenic properties and its Short Term Exposure

Limit (STEL) of 2ppm as set by OSHA. Hydrogen peroxide can cause cosmetic and functional changes in equipment UV radiation has several potential applications, but unfortunately its germicidal effectiveness and use is

influenced by organic matter; wavelength; type of suspension; temperature; type of microorganism; and UV intensity, which is affected by distance. UV radiation is not recommended to disinfect surfaces because of lack of penetration


http://www.epa.gov/oppad001/chemregindex.htm


The level of biocidal activity of Ortho-phthalaladehyde(OPA) was directly related to the temperature. 0.5% OPA was not sporicidal with 270 minutes of exposure

Paracetic Acid and Hydrogen Peroxide can cause cosmetic and functional changes in equipment



Table 1.Sterilizer/Disinfectant Micro-Organisms/Biologically Active Substances and Wastes

Spor

es

Gra

m (

-)

bact

eria

Gra

m (

+)

bact

eria

Non

lipid

or

Smal

l V

irus

es

Fung

i

Veg

etat

ive

bact

eria

Lipi

d or

M

ediu

m-

size

Vir

uses

DN

A

Cells

Prio

ns

Blo

odbo

rne

Path

ogen

s

Prot

ozoa

Was

tes

REF

EREN

CE

Steam Sterilization(specify temp, time, and pressure setting)Gaseous Disinfectants (ETO etc.) NRCommercial Disinfectant/Sterilizer NRAlcohols NR NR NR NR NR NR

C.parvumChlorine and Chlorine Compounds

NRC.parvumCryptosporidium

Glutaraldehyde NRFungal ascospores

NRSome mycobacteria

NRNRC.parvumCryptosporidium

Formaldehyde NR NR NR NR NR NR NR NR NR NR NR NR NRHydrogen Peroxide NRIodophores NR NR NROrtho-phthalaldehyde NRParacetic Acid NR NR

C.parvumParacetic Acid and Hydrogen Peroxide NRPhenolics NR NR NRQuaternary Ammonium Compounds

NR NR NR NRmycobacteria NR NR

C.parvumUltraviolet (UV) Radiation NR NR

= Not Recommended



Housekeeping

An organized, clean laboratory is imperative for safety and good research. Maintenance of safety equipment (i.e., emergency eyewashes) is also an important factor in keeping a safe laboratory environment. Routine cleaning and disinfection of all surfaces must be employed. Ensure that only cleanable, non-porous surfaces are used (i.e., fabric chairs shall not be used in the lab). Below, is a list of the routine cleaning/disinfection/maintenance procedures the lab will follow and their frequency:

Cleaning/Disinfection/Maintenance (Example: 10% Bleach dilution/contact

time 15 minutes)

Task/Procedure (Example: sprayed on bench tops)

Frequency (Example: nightly)

For a full description of disposal requirements for Biological Waste refer to:


Laundry

At Brown University cotton or fire-resistant lab coats are required. Synthetic lab coats are a risk for injury when working with open flames or pyrophoric chemicals because synthetic fibers burn, melt and stick to the skin at a higher rate than natural fibers.

Laboratory coats must be kept in the laboratory when not in use and should never be brought home for laundering. Laboratory coats that have been heavily contaminated with biological agents, infectious substances, or hazardous chemicals shall be replaced. Routine laundering of laboratory coats may be conducted in-house (if available) or by a professional laundering service and approved vendor. Contact Falvey Linen and Uniform Supply at 401-942-8900 for information about laundering lab coats or your purchasing representative to order disposable lab coats from approved vendors.

List the types of items specific to this lab or this protocol that may require laundering or replacement when contaminated:

Item (Example: Disposable lab coats) Replacement/Disposal/Laundering Frequency (Example: after contamination, autoclaved, disposed of

in garbage and replaced)

In addition, the following general laundering requirements must be met:

22Brown University Office of Environmental Health and SafetyApplication form revised 12/2012



Handle potentially contaminated laundry as little as possible, with minimal agitation Place wet laundry in leak-proof and appropriately labeled containers before transport Wear appropriate PPE when handling and/or sorting laundry

Labels and Door Signs

Any equipment or container contaminated with biological materials, bloodborne pathogens or OPIM must display the universal Biohazard symbol i.e., biological sharps containers, vacuum flasks etc.

To be NIH compliant, this symbol must also appear on any door where Biosafety Level 1 or 2 (BSL 1 or 2) work occurs or biological waste is held. Also required for a BSL-1 sign:

Biosafety Level Name of agent(s) in use Name and phone number of lab supervisor

Required for a BSL-2 sign: Biosafety level Laboratory supervisor’s name and telephone number required procedures for entering and exiting the laboratory

The standard CEMS emergency contact door sign posted on every laboratory door should reflect this information. If your current sign does not, contact EHS at 401-863-3353.

EMERGENCIES

In general, Brown University employees and students must not engage in spill response for hazardous substances such as chemical, biological, and radioactive materials. However, in some situations, such as clean up of incidental spills (i.e., a few drops), it is appropriate for the person who caused the incidental spill to clean up the material but only if they have been properly trained and have the appropriate equipment. All other spills must be reported to Brown University Public Safety at 863-4111 so that the Environmental Health & Safety Emergency Response Team may be activated.

In the event of a hazardous substance emergency or spill, the following action should be taken:

Immediately alert all personnel to evacuate the room. Once everyone is out, close the door behind you. Find a nearby phone and contact Brown University Public Safety at 863-4111. Tend to injured or contaminated personnel.



Stay in the general area, at a safe distance away, and wait for emergency responders. Introduce yourself to emergency responders as they arrive. Emergency responders want to ensure that the

information they have is accurate and that conditions have not changed since the initial phone call was made.

POST-EXPOSURE EVALUATION AND FOLLOW-UP

There are several types of exposure that could lead to injury or illness in faculty, staff and students:

Parenteral-puncture from a sharp, animal bites/scratches Mucous Membrane- contact through eyes, nose, mouth, inhalation Non-intact Skin-cut/scrape, rash, cold sore, acne, hang nail

Should an exposure incident occur:

• Immediately wash area with soap and water, or in case of an eye exposure flush with copious amounts of water use an emergency eyewash if available

• Notify your supervisor • Contact public safety at 401-863-4111

-if minor/low risk exposure, report to EHS as an alternative to calling public safety• Seek first aid/medical treatment and always consult with a physician i.e., health services, your doctor etc.• **If the exposure involves recombinant or synthetic nucleic acid molecules, the PI along with the

Biological Safety Officer will likely have to report it to NIH. A document explaining when this is necessary and how to file a report can be found here:

http://oba.od.nih.gov/oba/ibc/FAQs/FAQs_about_Incident_Reporting.pdf

For proper reporting use the forms found here:

http://www.brown.edu/Administration/EHS/lab/PDFs/accident_form.pdf

http://www.brown.edu/Administration/Office_of_Insurance_and_Risk/documents/Injury%20AR%20Form%20Rev.6%2706.doc.pdf

RESEARCHER TRAINING

All researchers who have reasonably anticipated occupational exposure to biological materials, bloodborne pathogens, or OPIM, or potentially dangerous equipment, should receive task-specific/equipment-specific training conducted by the Laboratory Supervisor or designee. The Laboratory Supervisor shall also ensure that task-specific/equipment-specific training is appropriately documented. The expectation is that this table will be used to declare any task-specific training you intend to document.

Provide below tasks/procedures for which laboratory researchers will receive task-specific/equipment-specific training:(Examples: Cardiac puncture blood-draw on mouse, centrifuge training)


http://www.brown.edu/Administration/Office_of_Insurance_and_Risk/documents/Injury%20AR%20Form%20Rev.6'06.doc.pdf

http://www.brown.edu/Administration/Office_of_Insurance_and_Risk/documents/Injury%20AR%20Form%20Rev.6'06.doc.pdf

http://www.brown.edu/Administration/EHS/lab/PDFs/accident_form.pdf

http://oba.od.nih.gov/oba/ibc/FAQs/FAQs_about_Incident_Reporting.pdf


RECORDKEEPING

Training Records

Training for task-specific/equipment-specific training shall be documented. These documents will be kept (Insert location of records here____________) for the duration of the Biological Research Authorization and any associated Renewals/Amendments.

The following training form template shall be used to document laboratory/equipment specific training:

http://www.brown.edu/Administration/EHS/restricted/supervisors_training_template.pdf

The training records include:

Dates of the training sessions Contents or a summary of the training sessions Names and qualifications of persons conducting the training Names and job titles of all persons attending the training sessions

Communication of Hazards

Informing Other Employers/Contractors

It is the responsibility of the Laboratory Supervisor to provide other employees and contractors with information about hazardous chemicals, biological materials, bloodborne pathogens, and OPIM that employees may be exposed to on a job site along with suggested precautions and PPE.

Before scheduling service with an outside contractor, the equipment to be serviced must be decontaminated unless that piece of equipment is being decontaminated by said outside contractor. In all events contractors or employees should use Universal Precaution while servicing equipment in a Brown University Laboratory.

Laboratory Moving/Closeout Policy

The purpose of the Brown University Closeout Policy is to ensure that all Research Laboratories and Research Support Areas are properly cleaned and decontaminated prior to decommissioning. Decommissioning of a laboratory or research support area may be necessary when a Laboratory Supervisor leaves the University, transfers to another space, or when a laboratory is prepared for demolition/renovation.

There are several resources available to assist Laboratory Supervisors and Departments with tasks related to the proper decommissioning of research space. Some of these resources include, but are not limited to, the following:

• Office of Environmental Health & Safety at 401-863-3353• Purchasing Department at 401-863-2206• Facilities Management at 401-863-7800

More information on this policy can be located at the following URL:http://www.brown.edu/Administration/EHS/restricted/lab_closeout.pdf


http://www.brown.edu/Administration/EHS/restricted/supervisors_training_template.pdf

Documents

Brown University · Web viewBrown University is committed to providing a safe and healthful work environment for faculty, students, and staff. In pursuit of this goal, the following