Part 2 by JyLifTad

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									                                                     CONFIDENTIAL INFORMATION




GM FORM A
RISK ASSESSMENT FOR AN ACTIVITY INVOLVING GENETICALLY MODIFIED MICRO-ORGANISMS
PART 2

 Person responsible for this work (the Principal Investigator)

 Name:

 Person conducting this assessment (if different from above)

 Name:

 The project

 Title:

 Imperial College Reference No:                                            Departmental Project Reference (if any):




2.1       IDENTIFICATION OF THE HAZARD TO HUMAN HEALTH
2.1.1.1 In which hazard group is each host organism placed by the Advisory Committee on Dangerous Pathogens?
2.1.1.2 Hazards associated with each host organism (e.g. bacterial host or viral vector)


2.1.1.3 What are the hazards associated directly from the inserted gene product?


2.1.1.4 If the function of the inserted gene is unknown, describe the function of any known homologues.


2.1.1.5 Hazards arising from the alteration of existing traits of the host


2.1.1.6 Hazards arising from the sequences within the GMM being transferred to related microorganisms



2.1.1     PROVISIONAL ASSIGNMENT OF A CONTAINMENT LEVEL ACCORDING TO THE CONTAINED USE
          REGULATIONS
Consider the containment level necessary to control the risk of the host to human health, making a judgment about whether the modification will
result in a GMM which presents hazardous, less hazardous or about the same.

 Containment Level

 1                                               2                                                  3

2.2        IDENTIFICATION OF THE HAZARD TO THE ENVIRONMENT
2.2.1.1 Hazards associated with the recipient microorganism (e.g. bacterial host or viral vector)


2.2.1.2 Hazards arising directly from the inserted gene product




 Imperial College London Safety Department                      Page 1 of 4                                                          17/10/07
                                                      CONFIDENTIAL INFORMATION
2.2.1.3 Hazards arising directly from the alteration of existing traits (e.g. alteration of pathogenicity, host range or tissue
        tropism)


2.2.1.4 The potential hazards of sequences within the GMM being transferred to related microorganisms



2.3        RISKS & CONTROL MEASURES
2.3.1.1 Most hazardous procedure
         Identify and describe the most hazardous procedure(s) involving the GMM to be created.



2.3.2      PREVENTING EXPOSURE
2.3.2.1 Substitution with a safer alternative
         Is substitution with a safer GMM practical? Provide reasons for your answer.



2.3.2.2 Isolation/ segregation
a)      Is the work and laboratory adequately separated from other areas e.g. write up areas? Provide details.



b)       Is/are the room(s) to be used for this work to be shared with other workers not involved directly in this activity? If yes, provide details.



c)       Is access to this laboratory restricted? Provide details.



2.3.3      CONTROLLING EXPOSURE
2.3.3.1 Containment and Ventilation
a)      Is the use of a microbiological safety cabinet required? In other words, will aerosols or splashes be generated during any stage of the
         activity and do these aerosols pose a risk of infection to the workers? If yes, specify the type(s) and when it/ they will be used.



b)       Is any other form of Local Exhaust Ventilation required?



c)       Are there any particular requirements for the room ventilation e.g. negative pressure, temperature control?



2.3.3.2 Storage
a)      Where will the GMMs be stored?



b)       If to be stored in Liquid Nitrogen, describe the precautions to be taken to prevent a release of infectious material whilst either loading
         or removing a sample from storage.



c)       What security measures are in place? Would you be able to easily and rapidly identify that a sample was missing?



2.3.3.3 Centrifugation
a)      Are GM samples to be centrifuged? If yes, describe amounts (conc. & volume) to be centrifuged?



b)       Will sealed rotors and buckets be used for this?



c)       Where will these rotors/buckets be opened?




 Imperial College Safety Department                                 Page 2 of 4                                                            17/10/07
                                                       CONFIDENTIAL INFORMATION
d)        Describe the procedures in place to deal with leaks or spillages in the centrifuge or rotor.



2.3.3.4 Use of incubators
a)     Are GMMs to be cultured in an incubator? If yes, what type of incubator (e.g. shaking or static shelf) is this and describe the measures
        to be used to prevent and contain any spillages therein.



2.3.3.5 Are animals to be infected with the GMO(s)? If yes, describe any additional risks that may arise and how these will be
        controlled.


2.3.3.6 Other hazardous procedures
          Describe any other hazardous procedures to be undertaken and the control measures to be implemented



2.3.3.7 Security
          Is this work notifiable under the Anti Terrorism Crime and Security Act?



2.3.3.8 Personal Protective Equipment
a)      Will laboratory coats be worn? If yes, what type are these and where will they be stored?



b)        Will gloves be worn? If yes, what type are these and where will they be stored?



c)        Is any other type of personal protective equipment to be used?



2.3.4      ADMINISTRATION CONTROLS
2.3.4.1 Maintenance
          Describe the maintenance and testing procedures for:

 Microbiological Safety Cabinets:

 Autoclaves:

2.3.4.2 Information, Instruction and Training
          Describe the training of all staff identified as being at risk of exposure. Include details on record keeping.



          Has a Local Code of Practice been prepared? If yes, is this available to all those at risk of exposure?



2.3.5      MEDICAL ISSUES
This section must be completed by the Occupational Physician for work at Containment Level 2, or higher.
This section is only completed once approval for the project is given from the GMSC.

2.3.5.1 Health effect



2.3.5.2 Medical risk assessment



2.3.5.3 Pre-exposure
                                                                          Details:

2.3.5.4 Post-exposure action




 Imperial College Safety Department                                Page 3 of 4                                                        17/10/07
                                                 CONFIDENTIAL INFORMATION
2.3.5.5 Antibiotic treatment or chemoprophylaxis



2.3.5.6 What health surveillance is required?



2.3.5.7 Additional notes/ comments



2.3.6       ASSIGNMENT OF FINAL CONTAINMENT LEVEL AND CLASSIFICATION
        Containment            Classification                                                 With derogation from certain controls
        Level                                                                                 (list these, if relevant. If required seek advice from your DSO or
                                                                                              the College GMSO)


        1                      1


        2                      2            HSE notification is required prior to
                                            commencement of work

        3                       3           HSE approval is required prior to
                                            commencement of work


PLEASE ENSURE THAT PART 3 OF THIS FORM IS COMPLETED AND ATTACHED TO PARTS 1 AND
2 PRIOR TO SUBMISSION TO THE LOCAL GMSC FOR APPROVAL.

DATA PROTECTION
The information provided on this form will be processed by the Safety Department in accordance with the College’s Data
Protection Policy.




 Review history                                                  The PI responsible for this project must ensure that this risk assessment remains valid
                             Review 1                    Review 2                         Review 3                                Review 4

 Due date

 Date conducted

 Conducted by




 Imperial College Safety Department                           Page 4 of 4                                                                              17/10/07

								
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