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UNIVERSITY OF TEXAS MEDICAL BRANCH Notification of Use BSL3/4 and CDC/USDA Regulated Agents The purpose of this document is to ensure adequate review of occupational safety and health precautions and the procedures for use, handling, storage, and disposal of biohazardous agents. As the Principal Investigator (P.I.) or Supervisor, you should be fully aware of the specifics of potential hazards associated with the agents used in your work area. THIS MAY BECOME A PUBLIC DOCUMENT; DO NOT INSERT PROPRIETARY OR SECURITY SENSITIVE INFORMATION. Type of Submission: New Renewal Type of Agents: Biological Agent Recombinant Material Select Agent: Yes No The information provided in this document is accurate to the best of my knowledge. I am familiar with, the agree to abide by the provisions set forth in this plan as approved by the University of Texas Medical Branch Biological Safety and Institutional BioSafety Committees, the UTMB Safety Manual, the UTMB Institutional Handbook of Operating Procedures (IHOP), 42 CFR 73, 7 CFR 331, 9 CFR 121, the BioSafety in Medical and Biomedical Laboratories, NIH/CDC, most current edition, and the NIH guidelines for recombinant material. When using recombinant DNA, I agree to comply with the NIH Guidelines for Research Involving Recombinant DNA Molecules. I accept responsibility for training all laboratory workers involved in the research project described in this “Notification of Use” before commencing any work. P.I. (Signature) Responsible for Research P.I. (Printed Name) Title Extension Department Date Submitted Route BIOLOGICAL SAFETY COMMITTEE USE ONLY DATE APPROVED ______________ DATE FOR RESUBMISSION ___________ ________________________________ Chairman (Signature) __________________________________ Printed Name NIH rDNA category BSL3-4-Revised 03/12 NOU Number ______________ For EHS use only 1 SECTION I: General information NOU are renewed every 5 years. Annual updates must be submitted (form sent by EHS annually). Amendments to the NOU do not change renewal date, original approval dates apply. 1. List agent(s): Attach a copy of the biological material safety data sheet if available, (http://www.phac-aspc.gc.ca/msds-ftss/index.html). 2. Goal of the project (1-2 sentences): 3. Description of use (include techniques used for in-vitro, in-vivo and vector work-do not copy detailed protocols or grant information, this section should typically be about ½ page long): 4. Location: Building: Room(s): 5. Can this agent infect humans? No Yes If yes, is the infection associated with replication in humans or is it abortive (no infectious progeny; for example viral replicons or defective adenoviral vecotrs)? Replication Abortive If yes, can it cause disease in: - healthy humans? - Immunocompromised people? No No Yes Yes 6. Is immunization required for work at the listed biosafety level? Is immunization recommended at the listed biosafety level? (other than Yellow Fever vaccine for Keiller/GNL BSL3/ GNL BSL3E) Unknown Unknown No No Yes Yes List vaccine: If this is not an FDA-licensed vaccine (e.g. it is an IND product available through the U.S. Army Special Immunizations Program or a product available outside the U.S.), check here, consult the supplemental Vaccination Risk Assessment Form, and include vaccination information in your description of personnel experience and skill on question No. 12) BSL3-4-Revised 03/12 2 7. Is medical surveillance recommended prior to commencement of work? No Yes (Other than the respiratory surveillance and baseline serum program for BSL3/ BSL3E and Medical clearance for BSL4) If yes, please explain (Post exposure management is considered part of occupational health exposure management) 8. Have you educated your staff regarding safe handling and decontamination procedures for the agents in this NOU? No Yes 9. a. Risk Assessment: Describe pathogenicity, including disease incidence and severity. b. Describe potential routes of laboratory transmission c. Describe agent stability (environmental stability in the lab, susceptibility to decontamination) d. What is the infectious dose? e. What is the concentration (number of infectious organism per unit volume) and the volume of the material being handled at one time? (maximum volume and concentration cultured at one time) f. What is the origin of the infectious material (may refer to geographic location, host or nature of source), from where will you receive your agent? g. Summarize any data available from animal studies (pathogenicity, infectivity and route of transmission in animal)? h. Is there an effective prophylaxis or therapeutic intervention available? Specify prophylaxis or therapeutic intervention? 10. Evaluation of Dual Use potential- experiments of concern (National Research Council Biotechnology Research in an Age of Terrorism, or “Fink Committee Report”). If answer “yes”, please explain in detail, use additional sheets as needed. BSL3-4-Revised 03/12 3 i. Would this research demonstrate how to render a vaccine (if applicable) ineffective? No Yes Specify: j. Would this research confer resistance to therapeutically useful antibiotics and antiviral agents? No Yes Specify: k. Would this research enhance the virulence of a pathogen, or render a non-pathogen virulent? No Yes Specify: l. Would this research increase transmissibility of this pathogen? No Yes Specify: m. Would this research alter the host range of this pathogen? No Yes Specify: n. Would this research enable the evasion of diagnostic/detection modalities of this agent? No Yes Specify: o. Would this research enable the weaponization of a biological agent or toxin? (the term “weaponization” includes, for example, enhancing the aerosol delivery of pathogens, new techniques for microencapsulation, and the synthesis of viral pathogens.) No Yes Specify: 11. What systems (cells and bacteria) are you using to propagate or study the agent(s) listed? 12. At what Biosafety Level will this agent be used? BSL2 BSL3 BSL3 E BSL4 13. Check the protective clothing or equipment used when handling this agent: Lab coat/ gloves/ eye protection (BSL2) Cover gown/ gloves/ eye protection (BSL3) Scrubs, cover gown/booties/gloves/ Dover/ Delta suits (BSL4) eye protection (BSL3E) PAPR (Racal/Max Air) Full/half face respirator Safety Centrifuge/blender Chemical Fume Hood Biological Safety Cabinet 14. N95 respirator Face Shield Other specify: Room location: Room location: Method for disposal of biohazardous waste: Placed in red bag for disposal. BSL3-4-Revised 03/12 4 Autoclaved, then placed in regular trash. Chemically disinfect, then placed in regular trash. Chemical disinfection of bulk liquid, then poured down sanitary drain (BSL3) or effluent treatment system (BSL3E and BSL4). Autoclaved, then packaged for incineration. (BSL 3 & 4 only) 15. List disinfectant(s) used for surface decontamination and spills: Cavicide Phenolic germicidal 70% alcohol MicroChem Other specify: 10% Bleach 16. Experience and skill level of personnel working with the material. Include experience with agents/cells, techniques used, animal species/procedures and biosafety levels. If applicable, please indicate if each staff member will be working with animals and/or arthropods and their specific experience with each. If you are using rDNA/RNA, please fill out section II If you are using a select agent, please fill out section III If you are planning any animal work, please fill out section IV If you are planning any arthropod vector work, please fill out section V BSL3-4-Revised 03/12 5 N/A N/A N/A N/A SECTION II: Recombinant DNA / RNA http://oba.od.nih.gov/rdna/nih_guidelines_oba.html Definition of a recombinant molecule per NIH-OBA guidelines In the context of the NIH Guidelines, recombinant DNA molecules are defined as either: (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii) molecules that result from the replication of those described in (i) above. Synthetic DNA segments which are likely to yield a potentially harmful polynucleotide or polypeptide (e.g., a toxin or a pharmacologically active agent) are considered as equivalent to their natural DNA counterpart. If the synthetic DNA segment is not expressed in vivo as a biologically active polynucleotide or polypeptide product, it is exempt from the NIH Guidelines. Genomic DNA of plants and bacteria that have acquired a transposable element, even if the latter was donated from a recombinant vector no longer present, are not subject to the NIH Guidelines unless the transposon itself contains recombinant DNA. 1. Goal of the project (1-2 sentences): 2. Description of the project (specific to recombinant work): 3. Location: Building: 4. At what biosafety level will you be conducting the cloning portion (not rescue) of your research: BSL1 5. Room(s): BSL2 BSL4 (full length viruses) Does this project involve synthetic DNA? Yes No Is this vector/insert commercially purchased? (No clone manipulation will be done in your lab.) Please provide the company’s name and product number: Yes No 7. Yes No 6. Is this vector/insert provided by a collaborator? (No clone manipulation will be done in your lab.) Please provide the collaborator’s institution: BSL3-4-Revised 03-12 6 8. Please fill out the following table Source of Insert DNA/RNA (Species) 9. Name of Vector(s) Used List them for all steps in the cloning process Name of Host(s) Used (bacteria or virus or cells) List them for all steps in the cloning process Nature of Inserted DNA Sequences If an attempt will be made to obtain expression of a foreign gene, indicate the protein that will be produced Answer the following questions, use additional pages if needed specify Additional info needed a) Does the inserted gene encode a known oncogene? b) Does the viral DNA integrate into the host genome? c) Does the modification have the potential to increase the replication capacity of virus? Does the modification increase the pathogenicity of the agent? Does the modification change the host range of the agent? e) Does the inserted gene have the potential for altering the cell cycle? h) Is there a probability of generating replication-competent viruses? BSL3-4-Revised 03-12 7 Yes No Yes No Yes No Yes No Yes No See section I10: Evaluation of Dual use Will this work involve the deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally? Other than E. coli cloning selection Yes No Could this acquisition compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture? Yes No Will this experiment involve the cloning of toxin molecules with LD50 of less than 100 Nanograms per Kilogram body weight (e.g., microbial toxins such as the botulinum toxins, tetanus toxin, diphtheria toxin, and Shigella dysenteriae neurotoxin)? Yes No A-1a B-1 a) Provide LD50 ng/Kg of body weight: b) Is this molecule lethal to vertebrates at 100 ng to 100 mg per kg body weight? c) Is the cloning done in Escherichia coli K-12? Yes No Yes No Will this experiment involving the deliberate transfer of recombinant DNA, or DNA/RNA derived from recombinant DNA, into one or more human research participants. Contact EHS before submitting Yes No C-1 Will this experiment involve using Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents as Host-Vector Systems? If no please go to section D-2. Yes No D-1 Will this experiment involve the introduction of recombinant DNA into Risk Group 2 agents? Yes No D-1-a Will this experiment involve the introduction of recombinant DNA into Risk Group 3 agents? Yes No D-1-b Will this experiment involve the introduction of recombinant DNA into Risk Group 4 agents? Yes No D-1-C Will this experiment involve the introduction of recombinant DNA into restricted agents? Yes No D-1-d Will this experiment involve DNA From Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents to be Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems? If no please go to section D-3 Yes No D-2 Yes No D-2-a a) Please list prokaryotes used b) Please list lower eukaryotes used Will this experiment involve DNA from Risk Group 2 or Risk Group 3 agents to be transferred into nonpathogenic prokaryotes or lower eukaryotes? BSL3-4-Revised 03-12 8 Yes No if no: work must be done at BSL4 Yes No D-2-b Will this experiment involve the Use of Infectious DNA/RNA Viruses in Tissue Culture Systems? Will this experiment involve the Use of Defective DNA/RNA Viruses in the Presence of Helper Virus in Tissue Culture Systems? If no please go to section D-4 Yes No D-3 Will this experiment involve the use of infectious or defective Risk Group 2 viruses in the presence of helper virus? Yes No D-3-a Will this experiment involve the use of infectious or defective Risk Group 3 viruses in the presence of helper virus? Yes No D-3-b Will this experiment involve the use of infectious or defective Risk Group 4 viruses in the presence of helper virus? Yes No D-3-c Will this experiment involve the use of infectious or defective restricted poxviruses in the presence of helper virus? Contact EHS before submission. Yes No D-3-d Will this experiment involve the use of infectious or defective viruses in the presence of helper virus, which are not covered in Sections III-D-3a through III-D-3-d? Yes No D-3-e Is the DNA from Risk Group 4 agents present in a given recombinant is totally and irreversibly defective fraction of the agent's genome? Will this experiment involve DNA from restricted agents to be transferred into nonpathogenic prokaryotes or lower eukaryotes? Will this experiment involve the use of Whole Animals? This section covers experiments involving whole animals in which the animal's genome has been altered by stable introduction of recombinant DNA, or DNA derived therefrom, into the germ-line (transgenic animals) and experiments involving viable recombinant DNA-modified microorganisms tested on whole animals. If no please go to section E. Will this experiment involve any of the following: 1) Recombinant DNA, or DNA or RNA molecules derived therefrom, from any source except for greater than two-thirds of eukaryotic viral genome may be transferred to any non-human vertebrate or any invertebrate organism. 2) Animals that contain sequences from viral vectors, which do not lead to transmissible infection either directly or indirectly as a result of complementation or recombination in animals. 3) For experiments involving recombinant DNA-modified Risk Groups 2, 3, 4, or restricted organisms. It is important that the investigator demonstrate that the fraction of the viral genome being utilized does not lead to productive infection. BSL3-4-Revised 03-12 9 Yes No Yes No D-4 D-4-a Will this experiment involve the use of replicating recombinant risk group 2-3-4 and restricted agents involving whole animals, including transgenic animals, and not covered by Sections III-D-1 or III-D-4-a? Yes No D-4-b Will this experiment involve the use of whole Plants? Contact EHS before submitting. Yes No D-5 / E-2 Will this experiment involve more than 10 Liters of culture? Contact EHS before submitting. Yes No D-6 Experiments with influenza viruses generated by recombinant methods (e.g., generation by reverse genetics of chimeric viruses with reassorted segments, introduction of specific mutations) work at the biosafety level corresponding to the risk group of the virus that was the source of the majority of segments in the recombinant virus Yes No D-7 Experiments with influenza viruses containing genes or segments from 1918-1919 H1N1 (1918 H1N1), human H2N2 (1957-1968) and highly pathogenic avian influenza H5N1 strains within the Goose/Guangdong/96-like H5 lineage (HPAI H5N1 work at BSL3E Yes No D-7 Human H2N2 (1957-1968). Experiments with influenza viruses containing the H2 hemagglutinin (HA) segment - work at BSL3E Yes No D-7a Human H2N2 (1957-1968). Experiments with the H2 HA gene in cold-adapted, live attenuated vaccine strains (e.g., A/Ann Arbor/6/60 H2N2) may be conducted at BL2 containment provided segments with mutations conferring temperature sensitivity and attenuation are not altered in the recombinant virus. Experiments with Risk Group 2 influenza viruses containing genes from human H2N2 other than the HA gene - work at BSL2. Yes No D-7a Highly Pathogenic Avian Influenza H5N1 strains within the Goose/Guangdong/96-like H5 lineage (HPAI H5N1). Experiments involving influenza viruses containing a minority/majority of genes and/or segments from a HPAI H5N1 influenza virus - work at BSL3E (contact EHS to lower biosafety level) Yes No D-7b 1918 H1N1. Experiments involving influenza viruses containing any gene or segment from 1918 H1N1- work at BSL3E Yes No D-7c Yes No D-7d (if yes mark A1 yes also a) Specify biosafety level worked at Antiviral Susceptibility and Containment. – contact EHS before submission An influenza virus containing genes from one of 1918 H1N1, HPAI H5N1, and human H2N2 (1957-1968) viruses is resistant to both BSL3-4-Revised 03-12 10 classes of current antiviral agents, adamantanes and neuraminidase inhibitors. Experiments with 1918 H1N1, human H2N2 (1957-1968) or HPAI H5N1 that are designed to create resistance to neuraminidase inhibitors or other effective antiviral agents (including investigational antiviral agents being developed for influenza) Will this experiment involve the Formation of Recombinant DNA Molecules Containing No More than Two-Thirds of the Genome of any Eukaryotic Virus? This section covers 1) Recombinant DNA molecules containing no more than two-thirds of the genome of any eukaryotic virus (all viruses from a single Family being considered identical) may be propagated and maintained in cells in tissue culture using BL1 containment. For such experiments, it must be demonstrated that the cells lack helper virus for the specific Families of defective viruses being used. 2) The DNA may contain fragments of the genome of viruses from more than one Family but each fragment shall be less than two-thirds of a genome. Yes No E-1 Will this experiment involve the use of arthropods? This section covers experiments with recombinant DNA-modified arthropods or small animals associated with plants, or with arthropods or small animals with recombinant DNA-modified microorganisms associated with them if the recombinant DNAmodified microorganisms have no recognized potential for serious detrimental impact on managed or natural ecosystems. Yes No E-2-b-5 Will this experiment involve the use of transgenic rodents? This section covers experiments involving the generation of rodents in which the animal's genome has been altered by stable introduction of recombinant DNA, or DNA derived therefrom, into the germ-line (transgenic rodents). Yes No E-3 Exempt Experiments. The following recombinant DNA molecules are exempt from the NIH Guidelines and registration with the Institutional Biosafety Committee is not required. The following recombinant DNA molecules are exempt: Those that are not in organisms or viruses. The following recombinant DNA molecules are exempt: Those that consist entirely of DNA segments from a single nonchromosomal or viral DNA source, though one or more of the segments may be a synthetic equivalent. The following recombinant DNA molecules are exempt: Those that consist entirely of DNA 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. BSL3-4-Revised 03-12 11 F Yes No F-1 Yes No F-2 Yes No F-3 The following recombinant DNA molecules are exempt: Those that consist entirely of DNA from an 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). The following recombinant DNA molecules are exempt: Those that 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. Contact EHS before starting. The following recombinant DNA molecules are exempt: Those that do not present a significant risk to health or the environment (see Section IV-C-1-b-(1)-(c), Major Actions), as determined by the NIH Director, with the advice of the RAC, and following appropriate notice and opportunity for public comment. See Appendix C, Exemptions under Section III-F-6 for other classes of experiments which are exempt from the NIH Guidelines. If you are using a select agent, please fill out section III N/A If you are planning any animal work, please fill out section IV N/A If you are planning any arthropod viral work, please fill out section V BSL3-4-Revised 03-12 12 Yes No F-4 Yes No F-5 Yes No F-6 N/A Section III: Select agent Transfer 1. Will select agent transfers (shipping and receiving) be conducted with institutions or agencies outside the UTMB campus? No 2. If yes describe: Will transfer of select agents be conducted within the UTMB campus? No 3. Yes Yes If yes describe: Please provide secondary contact person. Name: Work #: Cell #: Home #: If you are planning any animal work, please fill out section IV N/A If you are planning any arthropod viral work, please fill out section V N/A BSL3-4-Revised 03-12 13 Section IV: Animal Use A copy of the IACUC flow diagram must be provided. IACUC Protocol #: Species: IACUC Approval date: 1. Give a project description (specific to animal use, include techniques used per species and biosampling ½ page): 2. Can the infected animal present a human health risk after administration? No Yes Route of excretion: 3. Respiratory Blood Milk Other: Urine Feces Saliva What animal biosafety level is recommended? ABSL2 4. If yes describe provide the following information: ABSL3 ABSL3 E ABSL4 Check the protective clothing level and equipment used when handling the infected animal. Eye protection to be used at all biosafety levels ABSL2 PPE ABSL3 PPE Biological Safety Cabinet N95 Respirator PAPR (Racal/Max Air) ABSL3-E PPE ABSL4 Delta/Dover suits Chemical Fume Hood Full/ half-face respirator Other (specify): 5. Dose per animal (provide volume and concentration): 6. Route of administration: Intra-Cranial Intra-Peritoneal Intra-Venous Sub-Cutaneous Inhalation Gavage Other: BSL3-4-Revised 03-12 Intra-Dermal Intra-Cardiac Topical 14 Intra-Muscular Intra-Nasal Oral 7. 8. Biosampling: retro-orbital bleeds Intra-Venous bleeds Throat swabs Other: Sub-mandibular bleeds Saphenous bleeds Urine Milk Intra-Cardiac bleeds Nasal swabs Feces Specific animal procedures. Anesthetic used: Injectable Gas- drop method Anesthetic chamber Surgeries, specify type of surgery: Necropsy, specify organs removed: Perfusions. If checked, please describe the following: Perfusion system used: Method of collection of fluids: Trainer for the laboratory, Species: including experience and animal species: 9. Will the study use recombinant DNA, viral vectors, gene transfer experiments or creation of transgenic animals? Yes No 10. Are the vectors replicative deficient? 11. Discuss any safety concern associated with the vectors and also are there any toxins or virulence factors associated with the expression of transgene: 12. If there is a deviation from standard facility procedures for disposal/treatment of contaminated materials after usage (animals, bedding, glassware, bench tops, hoods, etc.), please describe. Yes None BSL3-4-Revised 03-12 15 No Note: Investigators are reminded that when planning experiments with animals which will include the use of hazardous agents, you must submit the Hazard Start-Up form located here: http://research.utmb.edu/arc/forms.shtm This is required at least 2 weeks prior to startup. All must have approval from the appropriate committee before you submit the form. If you are planning any arthropod viral work, please fill out section V BSL3-4-Revised 03-12 16 N/A Section V: Arthropod Use 1. Provide a description of the project (Specific to arthropod use): 2. Arthropod to be used: Mosquitoes 3. Indicate life stage used: Eggs 4. List animal species to be used: 5. What Arthropod Containment Level (ACL) is recommended? ACL2 ACL3 ACL4 6. Check the protective clothing level and equipment used when handling the infected arthropod. Eye protection to be used at all biosafety level. ACL2 PPE 7. Larvae ACL3 PPE Biological Safety Cabinet Infection method for arthropod: Intra-thoracic inoculation Fleas Nymphs Adults ACL4 Delta/Dover suit Glove box Other specify: Artificial blood meal Intra-rectal inoculation BSL3-4-Revised 03-12 Ticks 17 Animal feed