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									        General
      Instructions
                 English



    Version
English Version
 Genetic laboratory
   Safety level 1
Name des Institutes oder der Abteilung
  Westfalian Wilhelms-University
               Münster
UNI MS Dez. 4.5 b_gent_s1_e.doc 27.01.2005                                 2




          General Instructions
        Genetic engineering work
 according to §12 Gentechnik-Sicherheitsverordnung
         for Laboratories of Safety level 1
Institute:?????
Responsible: Projektleiter                   Tel.: ?????   e-mail: ?????




                                        Contents



1. Location
2. Responsible people
3. Genetic engineering work
4. Danger potential of GMOs
5. Safety measures, behavioural rules and hygienic measures
       5.1 Acess to the laboratory
       5.2 General instructions
       5.3 Hygienic measures
       5.4 Prohibition
       5.5 Protective Equipment
6. Behaviour in the case of danger
       6.1 Contamination with biological material
       6.2 Fire
7. First Aid
8. Correct waste disposal
9. Note on general references
10. Note on specific regulations
UNI MS Dez. 4.5 b_gent_s1_e.doc 27.01.2005                                                    3

1. Location
These Instructions are to be followed in the genetic laboratory (Genlabor) in the (Institut oder
Abteilung).
It includes the following rooms:
????.


These rooms are labelled as "Genetic Laboratory Safety Level 1" ("Genlabor
Sicherheitsstufe 1").



2. Responsible People

Responsible for the genetic laboratory (Projektleiter)          ???




Technical Assistant in the genetic laboratory                   ???



Responsible for Biological Safety within the Faculty            Dr. Joachim Kremerskothen
                                                                2 57 80
Responsible for safety and fire protection within the Inst.     ???


First aid                                                       ???



First aid                                                       ???


First aid


Medical office                                                  ???
Hospital                                                        ???



Eye clinic                                                      ???



Technical Service (Electricity, Gas, Water, Heating)            3 33 33
Technical Service (Telephone, Computers)                        3 11 17
Fire brigade/Emergency medical services:                        112
UNI MS Dez. 4.5 b_gent_s1_e.doc 27.01.2005                                                  4

3. Genetic engineering work

In the genetic laboratory, the following projects at safety level 1 are performed:


Stichwortartige Projektbeschreibung



The laboratory work for these and all future projects at safety level 1 have to be recorded in
detail, including a risk assessment according to GenTAufzV. The records for these projects
have to stored in the folder "Aufzeichnungen über die durchgeführten gentechnischen
Arbeiten", using the available forms.


The genetic engineering work includes the production, storage, transportation and disposal of
the genetically modified organisms.




4. Danger potential of GMO

The genetically modified organisms belong to risk group 1. This means that their appropriate
usage - according to these instructions - does not endanger healthy people or the environment.
A comprehensive risk assessment must accompany the filed records of the genetic engineering
work (see above).
UNI MS Dez. 4.5 b_gent_s1_e.doc 27.01.2005                                                     5

5. Safety measures, behavioural rules and hygienic measures

All projects should be performed in consideration of the general rules of microbiological
techniques and genetic engineering safety instructions. In particular, the following points
should be particularly taken into account:


5.1 Access to the genetic laboratory

a) Access is restricted to people, which have obtained safety instruction in yearly intervals.
   The safety instructions must include information about the hazards in the genetic
   laboratiry and the appropriate safety measures, as detailed in the different instructions for
   the genetic laboratory.
   This is restriction applies to every person which works in the genetic laboratory, even if
   he/she is not involved in genetic engineering.

b) Visitors may only enter the genetic laboratory in the presence of instructed people.
c) Personell for cleaning and maintenance of machines is only allowed to work in the
   genetic laboratory after having obtained safety instructions.
   It is sufficient to provide information about the main dangers and the relevant saftey
   measures. For the cleaners, a separate piece of information is posted in the genetic
   laboratory. For specific information, personell can approach the responsible person for
   the genetic laboratory (Projektleiter).
UNI MS Dez. 4.5 b_gent_s1_e.doc 27.01.2005                                                   6

5.2 General instructions

a) Every person must be familiar with the function and location of safety installations,
   including desinfectants, body shower, eye wash, first aid equipment, fire extinguisher
   equipment, and also eacape and safety routes.


b) The genetic laboratory is to be kept clean and tidy. The bench space should only bear work-
   related material and equipment. Spare material should be kept in the available cupboards
   and in the storage room.
   The specific instructions in the "Richtlinien für Laboratorien" must be followed, especially
   those referring to work with Gas bottles and inflammable solutions.


c) Within the genetic laboratory, writing is restricted to protocolling of experiments and must
   not include additional office work. The number of available books and catalogues should
   be kept at a minimum.


d) The doors to the genetic laboratory should be closed during genetic engineering work.
   Windows may be opened if air flow does not compromise the proper functioning of the
   safety cabinet or the extractor hood.


e) Pipetting aids must be used. "Mouth" pipetting is prohibited.


f) Scalpels, needles, etc. shall only be used if necessary. They must be colledtect for disposal
   in specific containers, labelled "Kontaminiertes Metall/Contaminated metal". These
   containers must be autoclaved before final disposal.

g) In all cases, the formation of aerosols should be avoided. Such aerosols may form while
   decanting, shaking, stirring, centrifuging, inoculating, or pipetting of solutions or while
   keeping solutions under high pressure.
   Possible measures to avoid formation of aerosols include:
   - usage of containers with a screwtop/twisted cap,
   - letting aerosols sink for a sufficient amount of time before opening containers,
   - avoidance of bubbles,
   - decanting or pipetting over short distances only,
   - avoidance of blowing out pipette tips.
UNI MS Dez. 4.5 b_gent_s1_e.doc 27.01.2005                                                   7


        h) The identity of the used organisms must be verified regularly by: i) plating out the
           recombinant E. coli onto Agar-plates and test for antibiotic-resistance; ii) PCR with
           specific primers for employed plasmid, subsequent restriction digestion and/or
           DNA sequencing.


        i) The operating guidelines for the different devices such as autoclave, safety cabinet,
           incubators, and centrifuges must be followed.


        j) Transportation of genetically modified organisms within the institute must be done
           using specific, fail-safe containers, labeled with "Gefäss zum Transport von
           GVOs/Container for transport of genetically modified organisms".


        k) Genetically modified organisms should be stored for short time periods in the
           fridge in room ????? or long time periods in the deep freezer in room ????.
UNI MS Dez. 4.5 b_gent_s1_e.doc 27.01.2005                                                8

5.3 Hygienic Measures

a) At the end of work, all benches must be cleaned either with water or with a detergent
   (depednign on the level of contamination). In case of a possible contamination with
   GMOs, the desinfectant (Desinfektionsmittel aus der RKI- oder DGHM-Liste) must be
   used (???; applied for approximately ??? min).


b) Contaminated surfaces of devices must be cleaned directly after usage, either with water
   or a detergent. In case of a possible contamination with GMOs, the desinfectant
   (Desinfektionsmittel aus der RKI- oder DGHM-Liste) must be used (???; applied for
   approximately ??? min.).


c) At the end of work, hands must be washed with the available soap. In case of a possible
   contamination with GMOs, the desinfectant (Desinfektionsmittel aus der RKI- oder
   DGHM-Liste) must be used (??? ml, applied for approximately ??? sec).

d) Devices and equipment are to be cleaned additionally in regular intervals. This will be
   done by the members of the laboratory.

e) With respect to contamination with biological material, see also under 6.1.
UNI MS Dez. 4.5 b_gent_s1_e.doc 27.01.2005                                                     9

5.4 Prohibition

a) Nutrition, stimulants, and cosmetica must not be stored inside the genetic laboratory.
   Instead, they can be stored in the available lockers in the hall.


b) It is not permitted to eat, drink or smoke inside the genetic laboratory. This is possible in
   room ???. These areas must not be entered with lab coats.


c) Mouth-pipetting is prohibited.


d) Water jet vacuum pumps must not be used for solutions, which may contain genetically
   modified organisms.


5.5 Protective equipment

a) People must wear a lab coat inside the genetic laboratory. These are washed in regular
   intervals.


b) Lab coats and protective gloves are to be taken off before leaving the laboratory.
   Protective gloves should be chosen in consideration of their chemical resistance, as
   inidcated by the manusfacturers. One-way gloves must be disposed after usage.


c) To avoid contaminations, protective clothings (e.g. lab coats) should be kept separate from
   street ware.
UNI MS Dez. 4.5 b_gent_s1_e.doc 27.01.2005                                                     10

6. Behaviour in the case of danger

- Do not panic and avoid hasty blindfold actions!
- Warn endangered people; if necessary, ask them to leave rooms.

- In all cases of emergency, the responsible for the genetic laboratory must be informed!


6.1 Contamination with biological material

Areas, where biological material is spilled, must be labelled immediately.
If the spilled biological material may contain genetically modified organisms, then it must be
inactivated immediately, using the following steps:
1) Absorption of material with a tissue paper
2) Disposal of tissue paper in autoclable bags
3) Autoclaving of bag
4) Cleaning of the bench surface or the object with a desinfectant
- Surfaces:       Wear protective gloves. Spilled Material is to be taken up with tissue paper and
                  to be autoclaved. Thereafter, the contaminated area must be desinfected, using
                  (Desinfektionsmittel aus der RKI- oder DGHM-Liste), applied for approximately
                  ??? min.
                  If glass break, then pieces of glass should be desinfected first and only thereafter
                  disposed off.
- Devices:
                 Wear protective gloves. Spilled Material is to be taken up with tissue paper and
                 to be autoclaved. Thereafter, the contaminated device must be desinfected, using
                 (Desinfektionsmittel aus der RKI- oder DGHM-Liste), applied for approximately
                 ??? min.).
UNI MS Dez. 4.5 b_gent_s1_e.doc 27.01.2005                                                     11

- Clothings:         Take off contaminated and desinfect with (Desinfektionsmittel aus der RKI-
                     oder DGHM-Liste) or autclave it. Thereafter, clothings should be washed


- Skin:              Contaminated skin should be desinfected with a sufficient volume of
                     (Desinfektionsmittel aus der RKI- oder DGHM-Liste) (??? applied for at least
                     ??? Sekunden). Thereafter, the affected areas can be rinsed with water.


- Eyes:              Eyes shall be rinsed with a lot of water using the eye wash. If necessary,
                     consult eye doctor.


- Mucosa:            Rinse mucosa with a lot of water. If necessary, consult doctor.




6.2 Fire

 In case of small fires, these should be extinguished with the help of the fire extinguishing
 equipment in room ???. Otherwise, call the fire brigade.



7. First aid

- Injuries
       - If possible, desinfect open wounds using (Desinfektionsmittel aus der RKI- oder
       DGHM-Liste) and apply bandage.
       - If a serious health hazard is suspected, a doctor should be called or visited
       - Injuries and accidents must be reported to the responsible person of the genetic
       laboratory (Projektleiter), and they must be recorded in the "accident book"
       (Verbandbuch) and the file "Besondere Vorkommnisse im Genlabor".
       These documents must be kept for at least 10 years.


- Inhaling or swallowing of genetically modified organisms
       The responsible person of the genetic laboratory (Projektleiter) must be informed
          immediately. Also, medical advice should be sought in order to find out whether
          further treatment is necessary. It is important to provide information on the type of
          organism and the amount of inhaled/swallowed material.
UNI MS Dez. 4.5 b_gent_s1_e.doc 27.01.2005                                                12

8. Correct waste disposal

Autoclavable bags must be available at the work place. Solid and liquid waste, which may
contain genetically modified organisms, must be inactivated before disposal. This is achieved
by autoclaving at 121°C for 20 min., using an autoclave.



9. Note on general references
Laws/regulations
- Gentechnikgesetz
  - Gentechnik-Sicherheitsverordnung und die Anhänge I-VI
  - Gentechnik-Aufzeichnungsverordnung
- Arbeitsschutzgesetz
  - Biostoffverordnung v. 27.01.1999 incl. Anhänge I-VII
      - Technische Regeln Biologische Arbeitsstoffe -TRBA ...
  - Betriebssicherheitsverordnung
  - Gefahrstoffverordnung und Anhänge I-IV
  - Technische Regeln Gefahrstoffe -TRGS ....
- Mutterschutzgesetz
  - Mutterschutzrichtlinienverordnung
- Geräte- und Produktsicherheitsgesetz
- Strahlenschutzverordnung
-
Publications of the Robert Koch-Institute/DGHM
- List of risk assessment on diverse donator and receiver organisms for genetic engineering
work
  (Bundesgesundheitsblatt 12/1997)
-List of disinfectants and desinfection procedures, tested and approved by the Robert Koch-
Institute (Bundesgesundheitsblatt 9/97)
-List of desinfectants by the Deutschen Gesellschaft für Hygiene und Mikrobiologie
 (Ausgabe Dez. 2003)

Regulations by the government safety organization
      -Rules for accident prevention (Unfallverhütungsvorschriften)

   GUV-V A1 Allgemeine Vorschriften     GUV-V 7z Zentrifugen
   GUV-V B12 Biologische Arbeitsstoffe GUV-V A4 Arbeitsmedizinische Vorsorge
   GUV-I 503 Anleitung zur Ersten Hilfe GUV-V C8 Gesundheitsdienst

       -BG-regulations/informations
       Laboratories (GUV-R 120)
UNI MS Dez. 4.5 b_gent_s1_e.doc 27.01.2005                                                    13

        -Series on safe biotechnology (Sichere Biotechnologie)

      BGI 628 (Technical terms)          BGI 633 (Bakteria)
      BGI 629 (Laboratories)             BGI 634 (Fungi)
      BGI 630 (Operation)                BGI 635 (Genetcially modified organisms)
      BGI 631 (Viruses)                  BGI 636 (Cell cultures)
      BGI 632 (Parasites)

DIN
        Laboratorien für Forschung, Entwicklung u. Analyse –Ausg. 5/98- (DIN EN 12128),
        Anforderungen an Labortische (DIN 12926),
        Sicherheitswerkbänke (DIN 12950 T.10), neu: prEN 12469
        Dampf-Sterilisatoren (DIN 58946)
        Abzüge (DIN 12924 T. 1-3)
        - DIN- Fachbericht Nr. 7
        "Verminderung des Infektionsrisikos in der medizinischen Mikrobiologie"

These references are available from the Beauftragten für Biologische Sicherheit, Dr. Joachim
Kremerskothen, Dezernat 4.5, Röntgenstraße 19, 48145 Münster (Email: bbs.uni@uni-
muenster.de).

10. Note on specific regulations
- Duty of notification
      The responsible person of the genetic laboratory (Projektleiter) must be informed about
      all incidents, which are unusual for genetic engineering work.
- Instructions
      People who work in the genetic laboratory must receive instructions before begin of
      work and in regular intervals (at least once per year). These instructions are given by the
      responsible person for the genetic laboratory (Projektleiter) in accordance with these
      written instructions and in consideration of the work planned. Content and time of
      instructions must be recorded in writing and confirmed by the instructed person with
      his/her signature.
- Duty of recording
      In the genetic laboratory, only genetic engineering work at safety level 1 are permitted.
      All genetic engineering work must be recorded using the available forms and including
      details about the preformed experiments and a risk assessment with information about
      the donator and receiver organsism, the genetically modified organisms, the vector and
      the cloned DNA region. The records must be stored for at least 10 years after
      completion of the work. These records are kept in the file "Aufzeichnungen über die
      durchgeführten gentechnischen Arbeiten".
      All accidents/injuries must also be recorded. These records must also be stored for at
      least 10 years in the file "Besondere Vorkommnisse im Genlabor".
- Fines
      Violations of the regulations of the genetic engineering laws (Gentechnikgesetz) may
      result in a fine of up to 50.000,- € and punitive measures of up to 5 years imprisonment.
      Furthermore, they may also result in compensation paymentsof up to 85.000.000- €.

								
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