PM 01-10

President James E. Lyons, Sr.

 


Recombinant DNA Project Registration


Instructions

The Biosafety Committee monitors the use of recombinant DNA at California State University, Dominguez Hills. All recombinant DNA projects require registration with the CSUDH Biosafety Committee.

Projects that require registration:

Projects that involve a living recombinant organism require registration with the CSUDH Biosafety Committee. Projects that require registration include those in which the only recombinant activity is the growing of plasmid in E. coli to make probes, the use of transgenic or knock-out animals, and experiments in which genes are cloned for site-directed mutagenesis. All (non-exempt, see below) projects will be initially reviewed by the Biosafety Committee and shall be updated whenever there is a change in procedure and personnel. In addition, projects will be updated and reviewed annually by the Office of Risk Management/Environmental Health & Occupational Safety (RM/EHOS).

Projects that do not involve living recombinants, e.g. the use of PCR and/or oligonucleotides alone, do not require registration.

Exempt projects:

The RM/EHOS office will review all projects and determine which projects are exempt and which require Biosafety Committee review. Exempt projects will require initial registration only, not annual updating. The RM/EHOS will notify you if your project is determined to be exempt.

Completing the form:

Location of the project: This information will be used to determine if the facility meets any special requirements to complete the project safely.

Animal use: The IACUC number is required if animals are used in conjunction with a recombinant DNA project.

Biological agent use: Complete this box if any infectious or regulated biological agents are used in the project. If so, please complete the bio-agent form also.

Isotope use: Complete this box if radioactive materials are used in the project.

Purpose: Use one sentence to outline the purpose of the project.

Technical description of the project: Describe the project to give the Biosafety Committee reviewers an understanding of the project.

If using viral vectors, mention the virus upon which the vector is based. List the amount of vector to be applied to cells or animals and the concentration used.

If applying recombinant virus or microorganisms to animals, list the amount and concentration of the vector or organism to be applied. Describe the application to the animal, i.e. injection, nasal application, applied through a cannula, etc. List any safety factors that you have already considered, like the use of blunt or self-sheathing needles or the use of a nasal inhalation containment device.

If using animals, describe the incubation period and what will be harvested or observed in the animal at the conclusion of the incubation period.

Describe the reason for using the specific genes and vectors, what outcome is expected, and what will be analyzed and/or measured.

Deliberate expression of genes: Answer yes or no. The information is used in conjunction with the NIH Guidelines to assess the appropriate containment level.

Production of toxins: Answer yes or no. The information is used in conjunction with the NIH Guidelines to assess the appropriate containment level.

Vectors: Please list vectors by name (e.g. pUC 18, pBS KS+, pTRUF-11) that will be used in the project. For vectors that are not commonly used or commercially available, please include a map detailing the regions of interest. The map may be hand drawn or a photocopy from a research article. The information is used to assess the appropriate containment level for each project.

Strains: List by strain name (e.g. HB101, JM109, 293T cells) any E. coli, other bacterial, yeast, insect, tissue culture, packaging, or other cells used for cloning, production, or expression in the project.

Genes: List the name of the nucleic acid sequence, gene, or protein that it encodes (green fluorescent protein, LacZ, DNA binding protein). For unknown genes, list the putative function. Please also list the source of DNA (human, murine, maize, Drosophila, etc.).

Bio-safety level and NIH Guideline citation: Use the web site http://www4.od.nih.gov/oba to find the NIH Guidelines online. Alternatively, leave this section blank and the RM/EHOS office will complete it for you.

Health Surveillance: Not all projects require health surveillance. Check the Agent List (attached) for use of biological agents that require health surveillance. For example, the use of vaccinia vectors or poliovirus may require immunization, the use of HIV may require testing and serum banking, and the use of Mycobacterium tuberculosis may require annual TB skin tests.

Personal Assurance Statement: All personnel, including other faculty, who work on a particular project must sign that they understand and will abide by the NIH Guidelines for Recombinant DNA Research. The Principal Investigator shall sign the statement assuring that all personnel will be trained and that the PI is responsible to ensure compliance with the guidelines.

Biosafety Committee Chair signature: Rarely, the Biosafety Committee Chair will be required to sign for a particular project. The CSUDH RM/EHOS will secure this signature.

Biological Safety Officer signature: In some cases, the RM/EHOS will sign or otherwise designate that a facility is in compliance with the NIH Guidelines.

For additional information, please contact the CSUDH Risk Management / Environmental Health & Occupational Safety, at 243-3995.                         

R-DNA

CSUDH Document of Registration RM/EHOS                                                                                                                                          

                                                                                                                #                                                                                                                                                                  

Principal Investigator:  FORMTEXT                                               PI’s Title:  FORMTEXT      

Department:  FORMTEXT                                                             Address/Box:  FORMTEXT      

Phone:  FORMTEXT                                                                     Email:  FORMTEXT      

Project Title:      

Grant #’s covered (optional)  FORMTEXT      

1.  Location of project
Project bldg.:  FORMTEXT      
Project room:  FORMTEXT      

2.  Animal Use    FORMCHECKBOX  Yes   FORMCHECKBOX  No

IACUC#:  FORMTEXT      
Rooms animals housed:  FORMTEXT      

3.  Biological Agent Use    FORMCHECKBOX  Yes   FORMCHECKBOX  No

Bio-Safety Office
approval date:  FORMTEXT      

4.       Isotope Use    FORMCHECKBOX  Yes   FORMCHECKBOX  No

RCC Approval date:  FORMTEXT      

 

5.  Purpose of the Project (one sentence):

     FORMTEXT      

6.   Technical description of project (use attachment if necessary):

     FORMTEXT      

 

7.   Will you attempt deliberate expression of a gene?   FORMCHECKBOX  Yes   FORMCHECKBOX  No

 

8.   Will you use or produce any toxins?    FORMCHECKBOX  Yes   FORMCHECKBOX  No

9.     Vectors

 FORMTEXT      

 

10. Strains (bacterial, yeast, cell lines)

 FORMTEXT      

 

11.  Genes (names of gene or name of protein it encodes)

 FORMTEXT      

 


 

12.  Bio-Safety Level and NIH Guideline Citation

 FORMTEXT      

 

13.  Health Surveillance

 FORMTEXT      

 

 

14.  The undersigned individual(s) will be involved in the experimentation described above.  They are familiar with and agree to abide by the current NIH Guidelines.

 

Name (Please Type or Print)                                  Signatures                                                                 Date

 FORMTEXT                                                                                                                                                                                                 

 FORMTEXT                                                                                                                                                                                                 

 FORMTEXT                                                                                                                                                                                                 

 FORMTEXT                                                                                                                                                                                                 

 FORMTEXT                                                                                                                                                                                                 

 

I attest to the fact that these individuals are properly trained in the area of recombinant DNA experimentation.  Furthermore, I agree to comply with the NIH requirements pertaining to shipment and transfer of recombinant DNA materials.  I am familiar with and agree to abide by the provisions of the current NIH Guidelines and other specific NIH instructions pertaining to the proposed project.  The information above is accurate and complete.

 

Text Box: Principal Investigator                                        Date

Principal Investigator                                        Date

 

 

 


 

Principal Investigator                                        Date

 

15. (If required) I certify that the BiosafetyCommittee has reviewed the proposed project for recombinant DNA experiments andhas found to be in compliance with the NIH Guidelines and other specific NIHinstructions pertaining to the project.

 

 

Text Box: Biosafety Committee Chairperson                 Date

Biosafety Committee Chairperson                 Date

 

 

 


 

Biosafety Committee Chairperson                 Date

 

16.   The indicated sites have been inspected and are in compliance with theNIH Guidelines.

 

 

Text Box: RM/EHOS                                                            Date

RM/EHOS                                                            Date

 

 

 


 

RM/EHOS                                                            Date

 

BiologicalAgent

CSUDH                                                                                                        Document of Registration

RM/EHOS

                                                                                                             # FORMTEXT     

                                                                                                                                                           

PrincipalInvestigator:                                             PI’s Title:     

Department:                                                           Address/Box:     

Phone:                                                                   Email:     

ProjectTitle:     

Grant#’s covered (optional)     

1. Location of project
Project bldg.:     
Project room:     

2. Animal Use   FORMCHECKBOX Yes  FORMCHECKBOX No

IACUC#:     
Rooms animals housed:     

3. R-DNA Use   FORMCHECKBOX Yes  FORMCHECKBOX No

BiosafetyCommittee approval date: FORMTEXT     

 4.      Isotope Use   FORMCHECKBOX Yes  FORMCHECKBOX No

RCCapproval date:     

5. Biological Agents
listagents                                                                    bio-safety level
     

 

6. Safety Procedures
personal protective equipment:  FORMTEXT     
method of inactivation of agent:  FORMTEXT     
disinfection of surfaces procedure:  FORMTEXT     

7.    Safety Equipment

bio-safety cabinet  FORMCHECKBOX Yes  FORMCHECKBOX No

model:  FORMTEXT     

location:  FORMTEXT     

certification date:      

 

 

autoclave available:  FORMCHECKBOX Yes  FORMCHECKBOX No

location:      

monitored:  FORMCHECKBOX Yes  FORMCHECKBOX No

 

8.    Description of Project:

     

 

 

9.    The undersigned individual(s) will be involvedin the experimentation described above. They are familiar with and agree toabide by the current CSUDH guidelines.

 

Name(Please Type or Print)                                 Signatures                                                                Date

                                                                                                                                                                                                

                                                                                                                                                                                                

                                                                                                                                                                                                

                                                                                                                                                                                                

                                                                                                                                                                                                

 

I attest to the fact that theabove named individuals are properly trained in this area of experimentation.

 

 

Text Box: Principal Investigator                                        Date

Principal Investigator                                        Date

 

 

 


 

Principal Investigator                                        Date

 

 

10. The indicated sites have been inspected and arein compliance with the CSUDH guidelines.

 

 

 

Text Box:  

 

 

 

 


 

RM/EHOS                                                            Date

 

 

                                                     AcuteToxin

CSUDH                                                                                                        Document of Registration

RM/EHOS

                                                                                                             #FORMTEXT     

                                                                                                                                                           

PrincipalInvestigator:                                             PI’s Title:     

Department:                                                           Address/Box:     

Phone:                                                                   Email:     

Project Title:     

Grant#’s covered (optional)     

1. Location of project:   Building                                  Room     
 

2.      Purpose of research:

       FORMTEXT     

3.    Name of toxin:      

LD50:                         mouse: FORMCHECKBOX    rat: FORMCHECKBOX    other: FORMCHECKBOX

 



 

 

4. Quantity on hand:  FORMTEXT     
(amount of material should be kept to a minimum)

 

5. Toxins are required to be kept in locked cabinetsor freezers. Is this being done?
 FORMCHECKBOX Yes  FORMCHECKBOX No

 

6. Please outline the safety practices being utilizedby the staff during the conduct of the project.
 FORMTEXT     

 

7. How is the compound inactivated/disposed of?
 FORMTEXT     

 

 

8.    We are familiar with the preceding informationand have been trained regarding emergency procedures in the event of anaccident.

 

Name(Please Type or Print)                                 Signatures                                                                Date

                                                                                                                                                                                                

                                                                                                                                                                                                

                                                                                                                                                                                                

                                                                                                                                                                                                

I certify that this information is complete and correct.

 

                        Text Box: Principal Investigator                                        Date

Principal Investigator                                        Date

 

 

 


 

  

9.    The indicated sites have been inspected and are in compliance with CSUDH guidelines.

 

 

 

Text Box:  

 

 

 

 


 

 

 

Biological WasteDisposal Policy

This policy is intended to provideguidance and insure compliance with the

NIH/CDC guidelines

 

Infectious/potentially infectious/R-DNA

a) human pathogens

b) animal pathogens

c) plant pathogens

d) recombinant DNA

e) human and primate blood, bloodproducts and other body fluids

f) human and primate tissue

g) any material containing orcontaminated with any of the above (test tubes,

needles*, syringes, tubing, culturedishes, flasks, etc.)

 

This waste must be inactivated prior todisposal. The preferredmethod is

steam sterilization (autoclaving),although chemical inactivation or incineration

may be appropriate in some cases.Storage of non-inactivated waste is restricted

to within the generating laboratory. Thematerial may not be stored longer than

     24 hours prior toinactivation.

 

 

Regulated BiologicalMaterials

Agents, such as plant pathogens orexotic microorganisms, that are regulated by

federal or state agencies (USDA/APHIS,EPA, FDA, DPI, etc.) shall be registered

with the RM/EHOS by submission of aphotocopy of the permit and

permit conditions that have been grantedby that agency. No special form is

required unless theagent fits into one of the first three categories.

 

Agents List

The following agents have been listedaccording to the most appropriate

Biological Safety Level to be used. Thelist presented below is based upon the

risk groups given in Appendix B of theMarch 1996Guidelines for Research

Involving Recombinant DNA Molecules(NIH Guidelines), the agentsummary

statements in the CDC/NIH publication,Biosafety in Microbiological and

Biomedical Laboratories (BMBL),3rdedition (1993), guidance from state andlocal

regulatory agencies, and recommendationsof the CDC.

Please note that Biological SafetyLevels are not inherent to an agent but are

performance recommendations and shouldbe chosen after a risk assessment is

completed.

A proper risk assessment takes intoaccount the characteristics of the agent

involved, the activities to beperformed, and the environment in which the work

will be completed. Therefore, certainagents may be used at different Biological

SafetyLevels depending upon the circumstances. For instance, human clinical

samples from HIV-positive patients maybe safely handled at BSL-2. Growth of

HIV in culture should be performed underBSL-3 containment. Biological Safety

Levels may be higher or lower than whatis given below for a particular agent

depending upon the circumstances of itsuse.

The RM/EHOSreviews all projects involving recombinant DNA, infectious disease agents, andagents of concern to livestock and agriculture and will assist you in the riskassessment process. Once the Biosafety Committee and/or the RM/EHOS assigns aBiological Safety Level, it must be adhered to unless new information to warranta change, in most cases from peer-reviewed literature, is provided. TheBiosafety Committee and/or RM/EHOS will review the literature and make anadjustment, if warranted.

 

Biological SafetyLevel 1 (BSL-1)

Agents that are not associated withdisease in healthy adult humans, are of

minimal potential hazard to laboratorypersonnel, and of minimal potential

hazard to the environment may be used atBSL-1. Agents that may be used at

BSL-1 includeLactobacillusspp.,asporogenicBacillus subtilisorBacillus

licheniformis,Escherichia coli-K12 (cloning strains), Baculoviruses, and adeno-associatedvirus types 1 through 4.

Those agents not listed under BiologicalSafety Levels 2, 3 and 4 are not

automatically orimplicitly classified in BSL-1; a risk assessment must be

conducted based on the known andpotential properties of the agents and their

relationship to agents that are listed.

 

 

Biological SafetyLevel 2 (BSL-2)

Agents to be used at BSL-2 areassociated with human disease which is rarely

serious and for which preventive ortherapeutic interventions are often available.

They are of moderate potential hazard tolaboratory personnel and/or the

environment.

BSL-2 Bacterial Agents IncludingChlamydia

·Acinetobacter baumannii(formerlyAcinetobacter calcoaceticus)

·Actinobacillus

·Actinomyces pyogenes(formerlyCorynebacterium pyogenes)

·Aeromonas hydrophila

·Amycolata autotrophica

·Archanobacterium haemolyticum(formerlyCorynebacteriumhaemolyticum)

·Arizona hinshawii -all serotypes

·Bacillus anthracis

·Bartonella henselae, B. quintana, B.vinsonii

·Bordetella including B. pertussis

·Borrelia recurrentis, B. burgdorferi

·Burkholderia(formerlyPseudomonasspecies)except those listed under BSL-3

·Campylobacter coli, C. fetus, C. jejuni

·Chlamydia psittaci, C. trachomatis, C.pneumoniae

·Clostridium botulinum, Cl. chauvoei, Cl.haemolyticum, Cl. histolyticum, Cl. novyi,

 Cl. septicum, Cl. tetani

·Corynebacterium diphtheriae, C.pseudotuberculosis, C. renale

·Dermatophilus congolensis

·Edwardsiella tarda

·Erysipelothrix rhusiopathiae

·Escherichia coli -all enteropathogenic, enterotoxigenic,enteroinvasive and

  strains bearing K1 antigen, includingE. coliO157:H7

·Haemophilus ducreyi, H. influenzae

·Helicobacter pylori

·Klebsiella -all species exceptK. oxytoca(BSL-1)

·LegionellaincludingL. pneumophila

·Leptospira interrogans -all serotypes

·Listeria

·Moraxella

·Mycobacterium(except those listed under BSL-3)includingM. avium complex,

  M. asiaticum, M. bovisBCG vaccine strain, M. chelonei, M.fortuitum, M.

  kansasii, M. leprae, M. malmoense, M.marinum, M. paratuberculosis, M.

  scrofulaceum, M. simiae, M. szulgai,M. ulcerans, M. xenopi

·Mycoplasma, except M. mycoides and M.agalactiaewhich arerestricted animal

  pathogens

·Neisseria gonorrhoea, N. meningitidis

·Nocardia asteroides, N. brasiliensis, N.otitidiscaviarum, N. transvalensis

·Rhodococcus equi

·SalmonellaincludingS. arizonae, S. cholerasuis,S. enteritidis, S. gallinarum-

  pullorum, S. meleagridis, S.paratyphi,A, B, C, S.typhi, S. typhimurium

·ShigellaincludingS. boydii, S. dysenteriae,type 1, S. flexneri, S. sonnei

·Sphaerophorus necrophorus

·Staphylococcus aureus

·Streptobacillus moniliformis

·StreptococcusincludingS. pneumoniae, S. pyogenes

·Treponema pallidum, T. carateum

·Vibrio cholerae, V. parahemolyticus, V.vulnificus

·Yersinia enterocolitica

BSL-2 - Fungal Agents

·Blastomyces dermatitidis

·Cladosporium bantianum, C. (Xylohypha)trichoides

·Cryptococcus neoformans

·Dactylaria galopava (Ochroconisgallopavum)

·Epidermophyton

·Exophiala (Wangiella) dermatitidis

·Fonsecaea pedrosoi

·Microsporum

·Paracoccidioides braziliensis

·Penicillium marneffei

·Sporothrix schenckii

·Trichophyton

BSL-2 - Parasitic Agents

·Ancylostomahuman hookworms includingA.duodenale, A. ceylanicum

·AscarisincludingAscaris lumbricoides suum

·BabesiaincludingB. divergens, B. microti

·Brugiafilaria worms includingB. malayi, B.timori

·Coccidia

·CryptosporidiumincludingC. parvum

·Cysticercus cellulosae(hydatid cyst, larva ofT. solium)

·EchinococcusincludingE. granulosis, E.multilocularis, E. vogeli

·Entamoeba histolytica

·Enterobius

·FasciolaincludingF. gigantica, F. hepatica

·GiardiaincludingG. lamblia

·Heterophyes

·HymenolepisincludingH. diminuta, H. nana

·Isospora

·LeishmaniaincludingL. braziliensis, L.donovani, L. ethiopia, L. major, L.

  mexicana, L. peruvania, L. tropica

·Loa loafilaria worms

·Microsporidium

·Naegleria fowleri

·Necatorhuman hookworms includingN.americanus

·Onchoercafilaria worms including,O. volvulus

·Plasmodiumincluding simian species, P.cynomologi, P. falciparum, P. malariae,

  P. ovale, P. vivax

·SarcocystisincludingS. sui hominis

·SchistosomaincludingS. haematobium, S.intercalatum, S. japonicum, S. mansoni,

  S. mekongi

·StrongyloidesincludingS. stercoralis

·Taenia solium

·ToxocaraincludingT. canis

·ToxoplasmaincludingT. gondii

·Trichinella spiralis

·TrypanosomaincludingT. brucei brucei, T. bruceigambiense, T. brucei rhodesiense,

 T. cruzi

·Wuchereria bancroftifilaria worms

BSL-2 - Viruses

Adenoviruses, human - all types

Alphaviruses (Togaviruses) - Group AArboviruses

·Eastern equine encephalomyelitis virus

·Venezuelan equine encephalomyelitisvaccine strain TC-83

·Western equine encephalomyelitis virus

Arenaviruses

·Lymphocytic choriomeningitis virus (non-neurotropicstrains)

·Tacaribe virus complex

·Other viruses as listed in theBMBL

Bunyaviruses

·Bunyamwera virus

·Rift Valley fever virus vaccine strainMP-12

·Other viruses as listed in theBMBL

Calciviruses

Coronaviruses

Flaviviruses (Togaviruses) - Group BArboviruses

·Dengue virus serotypes 1, 2, 3, and 4

·Yellow fever virus vaccine strain 17D

·Other viruses as listed in theBMBL

Hepatitis A, B, C, D, and E viruses

Herpesviruses - exceptHerpesvirussimiae(Monkey B virus), BSL-4

·Cytomegalovirus

·Epstein Barr virus

·Herpesvirus ateles

·Herpesvirus saimiri

·Herpes simplextypes 1 and 2

·Herpes zoster

·Human herpesvirus types 6 and 7

·Marek's disease virus

·Murine cytomegalovirus

·Pseudorabies virus

Orthomyxoviruses

·Influenza viruses types A, B, and C

·Other tick-borne orthomyxoviruses aslisted in theBMBL

Papovaviruses

·All human papilloma viruses

·Bovine papilloma virus

·Polyoma virus

·Shope papilloma virus

·Simian virus 40 (SV40)

Paramyxoviruses

·Newcastle disease virus

·Measles virus

·Mumps virus

·Parainfluenza viruses types 1, 2, 3, and4

·Respiratory syncytial virus

Parvoviruses

·Human parvovirus (B19)

Picornaviruses

·Coxsackie viruses types A and B

·Echoviruses - all types

·Polioviruses - all types, wild andattenuated

·Rhinoviruses - all types

Poxviruses

·vaccinia

·all types except Monkeypox virus (BSL-3)and restricted poxviruses

including Alastrim, Smallpox, andWhitepox (restricted to the CDC, Atlanta,

GA)

Reoviruses - all types includingColtivirus, human Rotavirus, and Orbivirus

(Colorado tick fever virus)

Retroviruses

·Avian leukosis virus

·Avian sarcoma virus

·Bovine leukemia virus

·Clinical samples from HIV-positivepatients

·Feline immunodeficiency virus

·Feline leukemia virus

·Feline sarcoma virus

·Gibbon leukemia virus

·Mason-Pfizer monkey virus

·Mouse mammary tumor virus

·Murine leukemia virus

·Murine sarcoma virus

·Rat leukemia virus

NOTE:Murine Retroviral Vectors

Murine retroviral vectors to be used forhuman transfer experiments (less than

10 liters) that contain less than 50% oftheir respective parental viral genome and

that have been demonstrated to be freeof detectable replication competent

retrovirus can be maintained, handled,and administered, under BL1

containment.

Rhabdoviruses

·Rabies virus - all strains

·Vesicular stomatitis virus - laboratoryadapted strains ONLY including VSV-Indiana,

San Juan, and Glasgow

Togaviruses (see Alphaviruses andFlaviviruses)

·Rubivirus (rubella)

 

Biological SafetyLevel 3 (BSL-3)

Agents to be used at BSL-3 areassociated with serious or lethal human disease

for which preventive or therapeuticinterventions may be available.

BSL-3 - Bacterial Agents IncludingRickettsia

·Bartonella

·BrucellaincludingB. abortus, B. canis, B.suis

·Burkholderia (Pseudomonas) mallei, B.pseudomallei

·Coxiella burnetii

·Francisella tularensis

·Mycobacterium bovis(except BCG strain, BSL-2),M.tuberculosis

·Pasteurella multocidatype B -“buffalo” and other virulentstrains

·Rickettsia akari, R. australis, R.canada, R. conorii, R. prowazekii, R. rickettsii, R,

siberica, R. tsutsugamushi, R. typhi (R.mooseri)

·Yersinia pestis

BSL-3 - Fungal Agents

·Coccidioides immitis(sporulating cultures; contaminatedsoil)

·Histoplasma capsulatum,H. capsulatumvar..duboisii

 

BSL-3 - Parasitic Agents

None

BSL-3 - Viruses and Prions

Alphaviruses (Togaviruses) - Group AArboviruses

·Semliki Forest virus

·St. Louis encephalitis virus

·Venezuelan equine encephalomyelitisvirus (except the vaccine strain TC-83

is BSL-2)

·Other viruses as listed in theBMBL

Arenaviruses

·Lymphocytic choriomeningitis virus (LCM)(neurotropic strains)

·Flexal

Bunyaviruses

·Hantaviruses including Hantaan virus

·Rift Valley fever virus

Flaviviruses (Togaviruses) - Group BArboviruses

·Japanese encephalitis virus

·Yellow fever virus

·Other viruses as listed in theBMBL

Poxviruses

·Monkeypox virus

Prions

·Transmissible spongioformencephalopathies (TME) agents, Creutzfeldt-Jacob

disease and kuru agents (seeBMBLfor specific containment

instruction)

Retroviruses

·Human immunodeficiency virus (HIV) types1 and 2

·Human T cell lymphotropic virus (HTLV)types 1 and 2

·Simian immunodeficiency virus (SIV)

Rhabdoviruses

·Vesicular stomatitis virus

 

Biological SafetyLevel 4 (BSL-4)

Agents to be used at BSL-4 are likely tocause serious or lethal human disease for

which preventive or therapeuticinterventions are not usually available.

BSL-4 - Bacterial Agents

None

BSL-4 - Fungal Agents

None

BSL-4 - Parasitic Agents

None

BSL-4 - Viral Agents

Arenaviruses (Togaviruses) - Group AArboviruses

·Guanarito virus

·Lassa virus

·Junin virus

·Machupo virus

·Sabia virus

Bunyaviruses (Nairovirus)

·Crimean-Congo hemorrhagic fever virus

Filoviruses

·Ebola virus

·Marburg virus

Flaviruses (Togaviruses) - Group BArboviruses

·Tick-borne encephalitis virus complexincluding Absetterov, Central

European encephalitis, Hanzalova, Hypr,Kumlinge, Kyasanur Forest

disease, Omsk hemorrhagic fever, andRussian spring-summer encephalitis

viruses

Herpesviruses (alpha)

·Herpesvirus simiae (Herpes B or Monkey Bvirus)

Paramyxiviruses

·Equine morbillivirus

Hemorrhagic feveragents and viruses as yet undefined

 

Toxins Table

Toxins with a mammalian LD50of<100 mg/kg must be registeredwith the

RM/EHOS. Therefore, use of the followingtoxins may require registration. If a toxin is not on the list, it still mayrequire registration, depending upon the LD50.For more information, please contact the RM/EHOS at 243-3995.

 

Toxicity

LD50(mg/kg)*

Abrin 0.7

Aerolysin 7.0

Botulinin toxin A 0.0012

Botulinin toxin B 0.0012

Botulinin toxin C1 0.0011

Botulinin toxin C2 0.0012

Botulinin toxin D 0.0004

Botulinin toxin E 0.0011

Botulinin toxin F 0.0025

b-bungarotoxin 14.0

Caeruleotoxin 53

Cereolysin 40-80

Cholera toxin 250

Clostridium difficileenterotoxin A 0.5

Clostridium difficilecytotoxin B 220

Clostridium perfringenslecithinase 3

Clostridium perfringenskappa toxin 1500

Clostridium perfringensperfringolysin O 13-16

Clostridium perfringensenterotoxin 81

Clostridium perfringensbeta toxin 400

Clostridium perfringensdelta toxin 5

Clostridium perfringensepsilon toxin 0.1

Conotoxin 12-30

Crotoxin 82

Diphtheria toxin 0.1

Listeriolysin 3-12

Leucocidin 50

Modeccin 1-10

Nematocyst toxins 33-70

Notexin 25

Pertussis toxin 15

Pneumolysin 1.5

Pseudomonas aeruginosatoxin A 3

Ricin 2.7

Saxitoxin 8

Shiga toxin 0.250

Shigella dysenteriaeneurotoxin 1.3

Streptolysin O 8

Staphylococcus enterotoxin B 25

Staphylococcus enterotoxin F 2-10

Streptolysin S 25

Taipoxin 2

Tetanus toxin 0.001

Tetrodotoxin 8

Viscumin 2.4-80

Volkensin 1.4

Yersinia pestis murine toxin 10

 

*Please note that the LD50values are from a number ofsources (see below). For

specifics on route of application (i.v.,i.p., s.c.), animal used, and variations on

the listed toxins, please go to thereferences listed below.

 

Reference:

1. Gill, D. Michael; 1982; Bacterialtoxins: a table of lethal amounts;

Microbiological Reviews;46: 86-94

2.Stirpe, F.; Luigi Barbieri; Maria GiuliaBattelli, Marco Soria and Douglas

A. Lappi; 1992; Ribosome-inactivatingproteins from plants: present status

and future prospects;Biotechnology;10: 405-412

3.Registry of toxic effects of chemicalsubstances (RTECS): comprehensive

guide to the RTECS. 1997. Doris V.Sweet, ed., U.S. Dept of Health and

Human Services, Public Health Service,Centers for Disease Control and

Prevention, National Institute forOccupational Safety and Health;

Cincinnati, Ohio