המחלקה לבטיחות ולגיהות האוניברסיטה העברית
פרק ה' - הנחיות עבודה בביוטכנולוגיה וסיווג הגורמים הביולוגיים
המדריך לבטיחות ביולוגית » פרק ה' - הנחיות עבודה בביוטכנולוגיה וסיווג הגורמים הביולוגיים

עבודה בביוטכנולוגיה תתבצע ביחידה ברמת בידוד או כליאה 1 עד 4
(Biosafety level 1-4) ולפי כל כללי הבטיחות, על פי דרגת הסיכון של הגורם הביולוגי ועל פי הנחיות NIH- National Institutes of Health.

א.  הנחיות NIH
NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) מתעדכנות באופן שוטף וניתן לקבל מידע באתר Office of Biotechnology Activities

וגם בקישורים הבאים:

מאמר

NIH Guildelines

RAC

מטרת הנחיות NIH הנה לפרט תהליכי בניה ועיסוק: (1) במולקולות של DNA רקומבינטי, (2) באורגניזמים ונגיפים המכילים מולקולות של DNA רקומבינטי.
הגדרת מולקולות של DNA רקומבינטי:  (1) מולקולות הנבנות מחוץ לתאים חיים על ידי חיבור של קטעי DNA למולקולות של DNA אשר מסוגלות להתרבות בתוך תא חי, או (2) מולקולות שנוצרות מהתרבות אלה שתוארו ב-(1) לעיל.

המסמך הנ"ל מתייחס לכל הקשור למחקר בביוטכנולוגיה:
1. ניסויים החייבים אישור, ניסויים החייבים רישום, ניסויים שאינם חייבים אישור וכד'.
2.  ניסויים בחיות שלמות.
3.  ניסויים בצמחים שלמים.
4.  ניסויים בנפח תרבית מעל 10 ליטרים.
5.  ניסויים במכרסמים טרנסגניים. 
6. ניסויים בהעברת גנים של אדם (Human gene transfer) .
7. תיאור של תנאי בידוד לניסויים ב-DNA רקומביננטי בצמחים, בחיות ובגורמים ביולוגיים הקשורים אליהם.

ב.  רשימת גורמים ביולוגיים לפי קבוצות סיכון על פי הנחיות   NIH 
כל עבודה עם גורם ביולוגי תתבצע ביחידה בהתאם לרמת הבטיחות הנדרשת לגבי קבוצת הסיכון הרלוונטית.


Classification of Human Etiologic Agents on the Basis of Hazard
(Appendix B )

This appendix includes those biological agents known to infect humans as well as selected animal agents that may pose theoretical risks if inoculated into humans.  Included are lists of representative genera and species known to be pathogenic; mutated, recombined, and non-pathogenic species and strains are not considered. Non-infectious life cycle stages of parasites are excluded.

This appendix reflects the current state of knowledge and should be considered a resource document. Included are the more commonly encountered agents and is not meant to be all inclusive. Information on agent risk assessment may be found in the Agent Summary Statements of the CDC/NIH publication, Biosafety in Microbiological and Biomedical Laboratories (see Sections V-C, V-D, V-E, and V-F, Footnotes and References of Sections I through IV. Further guidance on agents not listed in Appendix B may be obtained through: Centers for Disease Control and Prevention, Biosafety Branch, Atlanta, Georgia 30333, Phone: (404) 639-3883, Fax: (404) 639-2294; National Institutes of Health, Division of Safety, Bethesda, Maryland 20892, Phone: (301) 496-1357; National Animal Disease Center, U.S. Department of Agriculture, Ames, Iowa 50010, Phone: (515) 862-8258.

Appendix B - Basis for the Classification of Biohazardous Agents by Risk Group (RG)

Risk Group 1 (RG1): Agents that are not associated with disease in healthy adult humans.
גורמים ביולוגיים שאינם קשורים למחלות באדם מבוגר בריא.

Risk Group 2 (RG2): Agents that are associated with human disease which is rarely serious  and for which preventive or therapeutic interventions are often available.
גורמים ביולוגיים הקשורים למחלות אדם שאינן חמורות ושעבורם קיימים בדרך כלל אמצעי מניעה או ריפוי.

Risk Group 3 (RG3): Agents that are associated with serious or lethal human disease for
           which preventive or therapeutic interventions may be available (high 
           individual risk but low community risk).
גורמים ביולוגיים הקשורים למחלות חמורות או קטלניות באדם, שעבורם עשויים להיות אמצעי מניעה או ריפוי זמינים (סיכון גבוה לאדם אבל סיכון נמוך לציבור).

Risk Group 4 (RG4): Agents that are likely to cause serious or lethal human disease for which 
 reventive or therapeutic interventions are not usually available (high   
                                  individual risk and high community risk).
גורמים ביולוגיים שעלולים לגרום למחלות חמורות או קטלניות באדם, שעבורם
אמצעי מניעה או ריפוי אינם זמינים (סיכון גבוה לאדם וסיכון גבוה לציבור).

 

Appendix B-I. Risk Group 1 (RG1) Agents


RG1 agents are not associated with disease in healthy adult humans. Examples of RG1 agents include asporogenic Bacillus subtilis or Bacillus licheniformis (see Appendix C-IV-A, Bacillus subtilis or Bacillus licheniformis Host-Vector Systems, Exceptions), Escherichia coli K-12 (see Appendix C-II-A, Escherichia coli K-12 Host Vector Systems, Exceptions), adeno-associated virus (AAV) types 1 through 4, and recombinant AAV constructs, in which the transgene does not encode either a potentially tumorigenic gene product or a toxin molecule and are produced in the absence of a helper virus.
Those agents not listed in Risk Groups (RGs) 2, 3 and 4 are not automatically or implicitly classified in RG1; a risk assessment must be conducted based on the known and potential properties of the agents and their relationship to agents that are listed.

Appendix B-II. Risk Group 2 (RG2) Agents

RG2 agents are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available.

Appendix B-II-A. Risk Group 2 (RG2) - Bacterial Agents Including Chlamydia

                             --Acinetobacter baumannii (formerly Acinetobacter calcoaceticus)
                             --Actinobacillus
                             --Actinomyces pyogenes (formerly Corynebacterium pyogenes)
                             --Aeromonas hydrophila
                             --Amycolata autotrophica
       --Archanobacterium haemolyticum (formerly Corynebacterium
                             haemolyticum)                                                                                          
                             --Arizona hinshawii - all serotypes
                             --Bacillus anthracis
                             --Bartonella henselae, B. quintana, B. vinsonii
                             --Bordetella including B. pertussis
                             --Borrelia recurrentis, B. burgdorferi
      --Burkholderia (formerly Pseudomonas species) except those listed in
                                Appendix B-III-A (RG3))
                             --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, including E. coli O157:H7
                             --Haemophilus ducreyi, H. influenzae
                             --Helicobacter pylori
                             --Klebsiella - all species except K. oxytoca (RG1)
                             --Legionella including L. pneumophila
                             --Leptospira interrogans - all serotypes
                             --Listeria
                             --Moraxella
                             --Mycobacterium (except those listed in Appendix B-III-A (RG3))
                                including M. avium complex, M. asiaticum, M. bovis BCG 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. agalactiae which are restricted
                                animal pathogens
                             --Neisseria gonorrhoeae, N. meningitidis
                             --Nocardia asteroides, N. brasiliensis, N. otitidiscaviarum, N. transvalensis
                             --Rhodococcus equi
                             --Salmonella including S. arizonae, S. cholerasuis, S. enteritidis, S.
                                gallinarum-pullorum, S. meleagridis, S. paratyphi, A, B, C, S. typhi,
                                S. typhimurium
                             --Shigella including S. boydii, S. dysenteriae, type 1, S. flexneri, S. sonnei
                             --Sphaerophorus necrophorus
                             --Staphylococcus aureus
                             --Streptobacillus moniliformis
                             --Streptococcus including S. pneumoniae, S. pyogenes
                             --Treponema pallidum, T. carateum
                             --Vibrio cholerae, V. parahemolyticus, V. vulnificus
                             --Yersinia enterocolitica

Appendix B-II-B. Risk Group 2 (RG2) - Fungal Agents
                             --Blastomyces dermatitidis
                             --Cladosporium bantianum, C. (Xylohypha) trichoides
                             --Cryptococcus neoformans
                              --Dactylaria galopava (Ochroconis gallopavum)
                              --Epidermophyton
                              --Exophiala (Wangiella) dermatitidis
                              --Fonsecaea pedrosoi
                              --Microsporum
                              --Paracoccidioides braziliensis
       --Penicillium marneffei
                              --Sporothrix schenckii
                              --Trichophyton

Appendix B-II-C. Risk Group 2 (RG2) - Parasitic Agents

                             --Ancylostoma human hookworms including A. duodenale, A. ceylanicum
                             --Ascaris including Ascaris lumbricoides suum
                             --Babesia including B. divergens, B. microti
                             --Brugia filaria worms including B. malayi, B. timori
                             --Coccidia
                             --Cryptosporidium including C. parvum
                             --Cysticercus cellulosae (hydatid cyst, larva of T. solium)
                             --Echinococcus including E. granulosis, E. multilocularis, E. vogeli
                             --Entamoeba histolytica
                             --Enterobius
                             --Fasciola including F. gigantica, F. hepatica
                             --Giardia including G. lamblia
                             --Heterophyes
                             --Hymenolepis including H. diminuta, H. nana
                             --Isospora
                             --Leishmania including L. braziliensis, L. donovani, L. ethiopia, L. major,
                                L. mexicana, L. peruvania, L. tropica
                             --Loa loa filaria worms
                             --Microsporidium
                             --Naegleria fowleri
                             --Necator human hookworms including N. americanus
                             --Onchocerca filaria worms including, O. volvulus
                             --Plasmodium including simian species, P. cynomologi, P. falciparum,
                                P. malariae, P. ovale, P. vivax
                             --Sarcocystis including S. sui hominis
                             --Schistosoma including S. haematobium, S. intercalatum, S. japonicum,
                                S. mansoni, S. mekongi
                             --Strongyloides including S. stercoralis
                             --Taenia solium
                             --Toxocara including T. canis
                             --Toxoplasma including T. gondii
                             --Trichinella spiralis
                             --Trypanosoma including T. brucei brucei, T. brucei gambiense,
                                T. brucei rhodesiense, T. cruzi
                             --Wuchereria bancrofti filaria worms

Appendix B-II-D. Risk Group 2 (RG2) - Viruses

                             Adenoviruses, human - all types

                             Alphaviruses (Togaviruses) - Group A Arboviruses
                             --Eastern equine encephalomyelitis virus
                             --Venezuelan equine encephalomyelitis vaccine strain TC-83
                             --Western equine encephalomyelitis virus

                             Arenaviruses
                             --Lymphocytic choriomeningitis virus (non-neurotropic strains)
                             --Tacaribe virus complex
                             --Other viruses as listed in the reference source (see Section V-C,
                                Footnotes and References of Sections I through IV)

                             Bunyaviruses
                             --Bunyamwera virus
                             --Rift Valley fever virus vaccine strain MP-12
                             --Other viruses as listed in the reference source (see Section V-C,
                               Footnotes and References of Sections I through IV)

                             Calciviruses

                             Coronaviruses

                             Flaviviruses (Togaviruses) - Group B Arboviruses
                             --Dengue virus serotypes 1, 2, 3, and 4
                             --Yellow fever virus vaccine strain 17D
                             --Other viruses as listed in the reference source (see Section V-C,            
                             Footnotes and References of Sections I through IV)

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

                             Herpesviruses - except Herpesvirus simiae (Monkey B virus) (see Appendix
                             B-IV-D, Risk Group 4 (RG4) -Viral Agents)
                             --Cytomegalovirus
                             --Epstein Barr virus
                             --Herpes simplex types 1 and 2
                             --Herpes zoster
                             --Human herpesvirus types 6 and 7

                             Orthomyxoviruses
                             --Influenza viruses types A, B, and C
                             --Other tick-borne orthomyxoviruses as listed in the reference source (see
                             Section V-C, Footnotes and References of Sections I through IV)

                             Papovaviruses
                             --All human papilloma viruses

                             Paramyxoviruses
                             --Newcastle disease virus
                             --Measles virus
                             --Mumps virus
                             --Parainfluenza viruses types 1, 2, 3, and 4
                             --Respiratory syncytial virus

                             Parvoviruses
                             --Human parvovirus (B19)

                             Picornaviruses
                             --Coxsackie viruses types A and B
                             --Echoviruses - all types
                             --Polioviruses - all types, wild and attenuated
                             --Rhinoviruses - all types

                             Poxviruses - all types except Monkeypox virus (see Appendix B-III-D, Risk
                             Group3 (RG3) - Viruses and Prions) and restricted poxviruses including 
                             Alastrim, Smallpox, and Whitepox (see Section V-L, Footnotes and 
                             References of Sections I through IV)

                             Reoviruses - all types including Coltivirus, human Rotavirus, and Orbivirus
                             (Colorado tick fever virus)

                             Rhabdoviruses
                             --Rabies virus - all strains
                             --Vesicular stomatitis virus - laboratory adapted strains including
                             VSV-Indiana, San Juan, and Glasgow

                             Togaviruses (see Alphaviruses and Flaviviruses)
                             --Rubivirus (rubella)

Appendix B-III. Risk Group 3 (RG3) Agents

                             RG3 agents are associated with serious or lethal human disease for which
                             preventive or therapeutic interventions may be available.

Appendix B-III-A. Risk Group 3 (RG3) - Bacterial Agents Including Rickettsia

                             --Bartonella
                             --Brucella including B. abortus, B. canis, B. suis
                             --Burkholderia (Pseudomonas) mallei, B. pseudomallei
                             --Coxiella burnetii
                             --Francisella tularensis
                             --Mycobacterium bovis (except BCG strain, see Appendix B-II-A, Risk
                             Group 2 (RG2) - Bacterial Agents Including Chlamydia), M. tuberculosis
                             --Pasteurella multocida type B -"buffalo" and other virulent strains
                             --Rickettsia akari, R. australis, R. canada, R. conorii, R. prowazekii,
                             R. rickettsii, R. siberica, R. tsutsugamushi, R. typhi (R. mooseri)
                             --Yersinia pestis

Appendix B-III-B. Risk Group 3 (RG3) - Fungal Agents

                             --Coccidioides immitis (sporulating cultures; contaminated soil)
                             --Histoplasma capsulatum, H. capsulatum var. duboisii

Appendix B-III-C. Risk Group 3 (RG3) - Parasitic Agents

                             None

Appendix B-III-D. Risk Group 3 (RG3) - Viruses and Prions

                             Alphaviruses (Togaviruses) - Group A Arboviruses
                             --Semliki Forest virus
                             --St. Louis encephalitis virus
                             --Venezuelan equine encephalomyelitis virus (except the vaccine strain
                             TC-83, see Appendix B-II-D (RG2))
                             --Other viruses as listed in the reference source (see Section V-C,
                             Footnotes and References of Sections I through IV)

                             Arenaviruses
                             --Flexal
                             --Lymphocytic choriomeningitis virus (LCM) (neurotropic strains)

                             Bunyaviruses
                             --Hantaviruses including Hantaan virus
                             --Rift Valley fever virus

                             Flaviviruses (Togaviruses) - Group B Arboviruses
                             --Japanese encephalitis virus
                             --Yellow fever virus
                             --Other viruses as listed in the reference source (see Section V-C,
                             Footnotes and References of Sections I through IV)

                             Poxviruses
                             --Monkeypox virus

                             Prions
                             --Transmissible spongioform encephalopathies (TME) agents
                             (Creutzfeldt-Jacob disease and kuru agents) (see Section V-C,
                             Footnotes and References of Sections I through IV, for containment  
                             instruction)

                             Retroviruses
                             --Human immunodeficiency virus (HIV) types 1 and 2
                             --Human T cell lymphotropic virus (HTLV) types 1 and 2
                             --Simian immunodeficiency virus (SIV)

                             Rhabdoviruses
                             --Vesicular stomatitis virus

Appendix B-IV. Risk Group 4 (RG4) Agents

                             RG4 agents are likely to cause serious or lethal human disease for which
                             preventive or therapeutic interventions are not usually available.

Appendix B-IV-A. Risk Group 4 (RG4) - Bacterial Agents

                             None

 Appendix B-IV-B. Risk Group 4 (RG4) - Fungal Agents

                             None

Appendix B-IV-C. Risk Group 4 (RG4) - Parasitic Agents

                             None

Appendix B-IV-D. Risk Group 4 (RG4) - Viral Agents

                             Arenaviruses
                             --Guanarito virus
                             --Lassa virus
                             --Junin virus
                             --Machupo virus
                             --Sabia

                             Bunyaviruses (Nairovirus)
                             --Crimean-Congo hemorrhagic fever virus

                             Filoviruses
                             --Ebola virus
                             --Marburg virus

                             Flaviruses (Togaviruses) - Group B Arboviruses
                             --Tick-borne encephalitis virus complex including Absetterov, Central
                             European encephalitis, Hanzalova, Hypr, Kumlinge, Kyasanur Forest   
                             disease, Omsk hemorrhagic fever, and Russian spring-summer encephalitis
                             viruses

                             Herpesviruses (alpha)
                             --Herpesvirus simiae (Herpes B or Monkey B virus)

                             Paramyxoviruses
                             --Equine morbillivirus

                             Hemorrhagic fever agents and viruses as yet undefined

Appendix B-V. Animal Viral Etiologic Agents in Common Use

The following list of animal etiologic agents is appended to the list of human etiologic agents. None of these agents is associated with disease in healthy adult humans; they are commonly used in laboratory experimental work.

A containment level appropriate for RG1 human agents is recommended for their use. For agents that are infectious to human cells, e.g., amphotropic and xenotropic strains of murine leukemia virus, a containment level appropriate for RG2 human agents is recommended.

                             Baculoviruses

                             Herpesviruses
                             --Herpesvirus ateles
                             --Herpesvirus saimiri
                             --Marek's disease virus
                             --Murine cytomegalovirus

                             Papovaviruses
                             --Bovine papilloma virus
                             --Polyoma virus
                             --Shope papilloma virus
                             --Simian virus 40 (SV40)

                             Retroviruses
                             --Avian leukosis virus
                             --Avian sarcoma virus
                             --Bovine leukemia 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
Appendix B-V-1. Murine Retroviral Vectors
Murine retroviral vectors to be used for human transfer experiments (less than 10 liters) that contain less than 50% of their respective parental viral genome and that have been demonstrated to be free of detectable replication competent retrovirus can be maintained, handled, and administered, under BL1 containment.
                                                                                                           
Biological Containment (Appendix I).

מטרת בידוד ביולוגי הנה מניעת הישרדות של גורמים ביולוגיים המשמשים לביוטכנולוגיה בסביבה הטבעית. במערכות מאחסן-נשא 1 (host-vector 1 systems), למאחסן יש יכולת קיום נמוכה בסביבה הטבעית. הנשא חייב להיות תלוי במאחסן ללא יכולת לעבור לתאים אחרים. במערכות מאחסן-נשא 2 (host-vector 2 systems), למאחסן יש יכולת קיום נמוכה במיוחד בסביבה הטבעית והנשא תלוי אך ורק במאחסן.
Appendix I-I. Levels of Biological Containment

In consideration of biological containment, the vector (plasmid, organelle, or virus) for the recombinant DNA and the host (bacterial, plant, or animal cell) in which the vector is propagated in the laboratory will be considered together. Any combination of vector and host which is to provide biological containment shall be chosen or constructed so that the following types of "escape" are minimized: (i) survival of the vector in its host outside the laboratory, and (ii) transmission of the vector from the propagation host to other non-laboratory hosts. Levels of biological containment for prokaryotes are defined in Appendices I-I-A (Host-Vector 1 systems that provide a moderate level of containment) through I-II-B (Host-Vector 2 Systems that provide a high level of biological containment as demonstrated by data from suitable tests performed in the laboratory). Specific criteria will depend on the organisms to be used. 

Appendix I-II. Certification of Host-Vector Systems

Appendix I-II-A. Responsibility

Host-Vector 1 systems (other than Escherichia coli K-12) and Host-Vector 2 systems may not be designated as such until they have been certified by the NIH Director. Requests for certification of host-vector systems may be submitted to the Office of Biotechnology Activities, National Institutes ofHealth/MSC 7010, 6000 Executive Boulevard, Suite 302, Bethesda, Maryland 20892-7010, (301) 496-9838. Proposed host-vector systems will be reviewed.

Certified Host-Vector Systems (Appendix E).

While many experiments using Escherichia coli K-12, Saccharomyces cerevisiae, and Bacillus subtilis are currently exempt from the NIH Guidelines under Section III-F, Exempt Experiments, some derivatives of these host-vector systems were previously classified as Host-Vector 1 Systems or Host-Vector 2 Systems. A listing of those systems follows: 

Appendix E-I. Bacillus subtilis

Appendix E-I-A. Bacillus subtilis Host-Vector 1 Systems

The following plasmids are accepted as the vector components of certified B. subtilis systems:
     pUB110, pC194, pS194, pSA2100, pE194, pT127, pUB112,
                            pC221, pC223, and pAB124. B. subtilis strains RUB 331 and BGSC 1S53
                             have been certified as the host component of Host-Vector 1 systems based
                             on these plasmids. 

Appendix E-I-B. Bacillus subtilis Host-Vector 2 Systems

The asporogenic mutant derivative of Bacillus subtilis, ASB 298, with the following plasmids as the vector component:
                             pUB110, pC194, pS194, pSA2100,
                             pE194, pT127, pUB112, pC221, pC223, and pAB124. 

Appendix E-II. Saccharomyces cerevisiae

Appendix E-II-A. Saccharomyces cerevisiae Host-Vector 2 Systems

The following sterile strains of Saccharomyces cerevisiae, all of which have the ste-VC9 mutation, SHY1, SHY2, SHY3, and SHY4. The following plasmids are certified for use:
                             YIp1, YEp2, YEp4, YIp5, YEp6, YRp7, YEp20, YEp21, YEp24,
                             YIp25, YIp26, YIp27, YIp28, YIp29, YIp30, YIp31, YIp32, and YIp33. 

Appendix E-III. Escherichia coli

Appendix E-III-A. Escherichia coli (EK2) Plasmid Systems

The Escherichia coli K-12 strain chi-1776. The following plasmids are certified for use:
                              pSC101, pMB9, pBR313, pBR322, pDH24, pBR325, pBR327, pGL101,
                              and pHB1.
The following Escherichiacoli/S. cerevisiae hybrid plasmids are certified as EK2 vectors when used in Escherichia coli chi-1776 or in the sterile yeast strains, SHY1, SHY2, SHY3, and SHY4:
                             YIpI, YEp2, YEp4, YIp5, YEp6,
                             YRp7, YEp20, YEp21, YEP24, YIp25, YIp26, YIp27, YIp28, YIp29,
                             YIp30, YIp31, YIp32, and YIp33. 


Appendix E-III-B. Escherichia coli (EK2) Bacteriophage Systems
 
The following are certified EK2 systems based on bacteriophage images/lambda: 
                              Vector                  Host
                              gt WESB'  DP50supF 
                              gt WESB*  DP50supF 
                              gt ZJ virB'  Escherichia coli K-12 
                              gtALOB  DP50supF 
                              Charon 3A  DP50 or DP50supF 
                             Charon 4A   DP50 or DP50supF 
                             Charon 16A  DP50 or DP50supF 
                             Charon 21A  DP50supF 
                             Charon 23A  DP50 or DP50supF 
                             Charon 24A  DP50 or DP50supF 

                             Escherichia coli K-12 strains chi-2447 and chi-2281 are certified for use
                             with images/lambda vectors that are certified for use with strain DP50 or
                             DP50supF provided that the su-strain not be used as a propagation host. 

Appendix E-IV. Neurospora crassa

Appendix E-IV-A. Neurospora crassa Host-Vector 1 Systems

The following specified strains of Neurospora crassa which have been modified to prevent aerial dispersion: 
                             In1 (inositolless) strains 37102, 37401, 46316, 64001, and 89601. Csp-1
                             Strain UCLA37 and csp-2 strains FS 590, UCLA101 (these are conidial
                             separation mutants). 

                             Eas strain UCLA191 (an "easily wettable" mutant). 

Appendix E-V. Streptomyces

Appendix E-V-A. Streptomyces Host-Vector 1 Systems

The following Streptomyces species: Streptomyces coelicolor, S. lividans, S. parvulus, and S. griseus.
The following are accepted as vector components of certified Streptomyces Host-Vector 1 systems: Streptomyces plasmids SCP2, SLP1.2, pIJ101, actinophage phi C31, and their derivatives. 


Appendix E-VI. Pseudomonas putida

Appendix E-VI-A. Pseudomonas putida Host-Vector 1 Systems

                             Pseudomonas putida strains KT2440 with plasmid vectors pKT262,
                             pKT263, and pKT264.

בהנחיות NIH ניתן למצוא מידע גם בנושאים:
Physical Containment for Large Scale Uses of Organisms Containing Recombinant DNA Molecules (Appendix K).
מתייחס לביוטכנולוגיה בקנה-מידה גדול (נפח תרבית של יותר מ10- ליטרים).

Physical and Biological Containment for Recombinant DNA Research Involving Plants (Appendix P).

Physical and Biological Containment for Recombinant DNA Research Involving Animals (Appendix Q).

ג.  סילוק פסולת

אין לפנות פסולת המכילה E. coli או גורם ביולוגי אחר לאחר ניסוי בביוטכנולוגיה, ללא טיהור מתאים באמצעות עיקור באוטוקלב, טיפול בחומר חיטוי או שרפה (ראו פרק ט').

ד.  אישורי מחקר בביוטכנולוגיה

1. אישור למחקר בביוטכנולוגיה באוניברסיטה יינתן על ידי ממונה בטיחות ביולוגית לאחר פנייה של החוקר באמצעות טופס "נספח בטיחות" בהוראות הנהלה מס' 21-005. יש לפרט את הסיכונים לעובדים ולסביבה הקשורים למחקר.
2. האישור יינתן לאחר סיור ביחידה, שלפיו ייקבע אם התשתית אכן מאפשרת ביצוע המחקר על פי נוהלי הבטיחות הביולוגיים הדרושים.
3. אין לבצע ניסויי בביוטכנולוגיה בצמחים ובמיקרואורגניזמים הקשורים אליהם, ברמת המעבדה, החממה והשדה ו/או לייבא חומר צמחי מהונדס, ללא אישור הוועדה הראשית לצמחים מהונדסים, שבחסות משרד החקלאות. יש לדווח לחבר הוועדה המייעצת לבטיחות ביולוגית ו/או לממונה בטיחות ביולוגית על מועדי תחילת הניסוי וסיומו ועל אמצעי השמדת החומר הביולוגי.
 ניתן לפנות לת"ד 6, בית דגן 50250 (טל' 03-9682309, פקס' 03-9697193) לקבלת הטפסים הדרושים.

 

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האתר עודכן בתאריך 19/09/17
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