Information Sheet RISK ASSESSMENT FORM FOR AN ACTIVITY INVOLVING GENETICALLY MODIFIED MICROORGANISMS

Size: px
Start display at page:

Download "Information Sheet RISK ASSESSMENT FORM FOR AN ACTIVITY INVOLVING GENETICALLY MODIFIED MICROORGANISMS"

Transcription

1 Information Sheet RISK ASSESSMENT FORM FOR AN ACTIVITY INVOLVING GENETICALLY MODIFIED MICROORGANISMS The Risk Assessment Form must be completed and permission received from the GM Safety Committee prior to commencement of any project. A new Form should accompany any grant application which proposes work likely to be covered by the ACGM Regulations. The Form should be completed in typescript. A "Word" template is available from the Health and Safety Advisor (Biological Sciences) (HSA(BS) (David Nelson) who will be happy to answer any queries regarding this Form. You may wish also to consult the University Health and Safety Department Web Site for further information. This form consists of a number of questions which are intended to prompt the assessor to consider the potential human health and environmental hazards of their GM activity and what control measures are needed to reduce the associated risks as low as possible. Most routine cloning work with E.coli K12 derivatives will require only a brief. However, no matter how trivial a cloning procedure may appear a risk must be carried out. For activities where there is some uncertainty a more in depth is. The detail will vary, but if a hazard is identified then a more detailed risk must be carried out The main Risk Assessment Form is set out in three main sections: 1. risk to human health 2. consideration of the nature and scale of the actual activity 3. risk to the environment before deciding on the final classification Sources of Useful Information The following sources provide additional information which will assist you in the successful completion of your risk. Advisory Committee On Genetic Modification (ACGM) Compendium Of Guidance: Advisory Committee On Dangerous Pathogens (ACDP) Guidance On The Categorisation Of Biological Agents: Current HSE Newsletters giving guidance on the new regulations: Department of Environment, Food and Rural Affairs (DEFRA) home page: David Nelson 1 05/04/02

2 1. Section 1: Background and objectives of GMO project Brief, yet clear outline only please. If the project involves a number of related GM activities, outline how they are related and the objectives of each activity. 2. Section 2: Summary and conclusions of risk What are the main risks to human health and the environment? If none, briefly explain why. What containment level is to contain the GMO? 3. Section 3: Details of host cells / vector and target DNA / gene A Bacterial Systems Host The bacterial host should be named. If a commercially available strain the supplier s information should be attached (unless one of the common strains such as the JM, Series, DH5, XL-1 blue etc. are being used). Host ACDP If the host organism is a pathogen the ACDP Category should be listed. These categories are outlined in "Advisory Committee on Dangerous Pathogens: Categories of Pathogens according to Hazard and Categories of Containment. Third Edition 1998". If a veterinary pathogen is to be used then the "Specified Animal Pathogens Order 1998" should be consulted. These documents are on the web at (ACDP) or (Animal Pathogens). If the pathogen is a novel pathogen please contact the HSA(BS). K-12 derivatives of E. coli, which include commonly used strains such as C600, DH1, DH5, HB101, INV1, JM109, TB1, TG1, X-1Blue and the commercial derivatives of them are noncolonising and disabled (for BL-21 see below). They are equivalent to hazard group 1, as they are not pathogenic to humans or animals. They often have auxotrophic requirements (this may vary from strain to strain) which are unlikely to be satisfied outside laboratory cultures. They have very limited survivability in the environment. Recent research commissioned by the HSE (Chart et al An investigation into the pathogenic properties of Escherichia coli strains BLR, BL21, DH5a and EQ1. J Applied Microbiology, 89, p ) showed that BL21 is unlikely to be pathogenic, lacking any of the pathogenic mechanisms associated with E. coli strains involved in enteric infections. BL21 may be considered unlikely to colonise and establish a persistent infection in the gut of a healthy individual. This information implies that BL21 can be considered broadly equivalent to K12 strains in many circumstances, and that, in most cases, work which uses this host can be classified as a Class 1 activity. However, there are some instances where using a K12 strain would be preferable. For example, work that involves the cloning of a bacterial pathogenicity determinant into BL21 will need careful consideration and may in some cases warrant classification as Class 2. In all cases the classification of the work will be dependent on factors such as; the plasmids to be used, sequences to be inserted, and how the GMM is to be used as well as the nature of the host strain. Vector/Source The plasmid/bacteriophage vector should be described. If a commercially available vector, the supplier's information should be attached. The puc series of plasmids (and those like them, which includes many commercial vectors; this includes pat153, pbr, pbluescript, pbs, pgem, pcat, pex, pt7, pmsg, pxt, pembl) are nonmobilisable. The selectable marker gene (Amp R ) codes for resistance to an antibiotic not in clinical use. This may not be true for other antibiotic resistance genes such as Tet R. David Nelson 05/04/02 2

3 Target DNA/Gene The gene of interest which is to be cloned should be named. If a shotgun approach is to be taken or if more than one gene is being targeted this should be stated. Special mention should be given to the use of any potential oncogenic sequences. The method of cloning i.e. genomic, cdna, PCR, RT-PCR or other should be stated. Source The organism from which the nucleic acid is to derived should be described. Source ACDP If the organism from which the nucleic acid is to be derived is a pathogen, the ACDP Category should be listed. See Host ACDP (above) for further information. Scale The scale of the experiments proposed should be indicated i.e. < 100ml; < 1L; < 10L; > 10L. B Eukaryotic Systems In all situations where a project involves an initial cloning step in a prokaryotic host/vector system then Section 1 A (Bacterial Systems) should also be completed. Cell Line The cell type to be used should be described. Include species, cell type and any special features e.g. SV40 T antigen positive, EBV transformed. Tissue culture cell lines are normally Category 1, however, uncharacterised cell lines, those which are virus +ve or primary cultures of human or simian nervous system, lymphoid organs, etc, should be categorised as Category 2. Target DNA/Gene See section above. The normal biological function of the gene to be expressed should be described. If a non-human gene is being expressed the homology to its human counterpart should be stated (if known). Source ACDP If the organism from which the nucleic acid is to be derived is a pathogen, the ACDP Category should be listed. See Host ACDP (above) for further information. Selection System The selection system to be used should be described. C Viral Vectors Target DNA/Gene See above. The normal biological function of the gene to be expressed should be described. If a non-human gene is being expressed the homology to its human counterpart should be stated (if known). Source ACDP If the organism from which the nucleic acid is to be derived is a pathogen, the ACDP Category should be listed. See Host ACDP (above) for further information. Cell The cell type to be used should be described. Virus The virus to be used should be fully described. If commercially available the supplier s information should be attached. If non-commercial, then all available information on genotype, etc, should be supplied. David Nelson 05/04/02 3

4 Virus ACDP If the virus is a pathogen, the ACDP Category should be listed. See Host ACDP (above) for further information. Selection System The selection system to be used should be described. 4. Section 4: Identification of potential harmful effects of the GMM to human health This section considers: the potential harm to human health from the pathogenicity, biological effects, and toxicity of the host organism / cell, foreign gene product and the mobility of the plasmid risk that, in the event of exposure, the GMM could actually cause harm to human health before assigning a provisional containment level. A Potential harm to human health Specifically the following must be considered: a) Hazards associated with host (e.g. Host ACDP, colonisation potential) b) Hazards associated with the vector (e.g. mobilisation state) c) Hazards associated with inserted gene d) Hazards arising from the alteration of existing pathogenic traits e) Considerations relating to whether an inserted sequence, that does not give rise to a harmful phenotype in the recipient GMM, could give rise to harm as a result of natural gene transfer to another, possibly related, organism. B Risk that, in the event of exposure, the GMM could actually cause harm to human health For each potential hazard you are to assess the associated level of risk. Identify the level of risk of causing harm to human health represents by combining: a) the consequence, in the event of exposure, of the hazard (i.e. the level of harm that could theoretically be realised) and, b) the likelihood that, in event of exposure, the GMM could actually cause harm to human health using the matrix below. Express risk as high, medium, low, or effectively zero. Estimation of Risk Consequence of Hazard Likelihood of Risk High Medium Low Negligible Severe High High Medium Effectively Zero Medium High Medium Medium/Low Effectively Zero Low Medium/Low Low Low Effectively Zero Negligible Effectively Zero Effectively Zero Effectively Zero Effectively Zero David Nelson 05/04/02 4

5 The likelihood of harm to human health considers the ability of a GMM to establish an in vivo infection and the efficiency of subsequent in vivo propagation. Also involves an of the FITNESS of the GMM. The initial stage identifies features of GMM which have potential to cause harm, BUT these scenarios can be theoretical and it may be possible to provide justifications which say that the likelihood of these scenarios being realised is vanishingly small. Probabilistic Considerations In some cases it may be possible to assign a frequency, precise or approx, to an event e.g. plasmid transfer or recombination. In other cases may be possible to only use semi-quantitative methods based on previous experience with other GMMs or the working practice to be utilised, e.g. if relying on a disabling mutation then reversion rates of that mutation should be considered and if the rate is high then should consider multiple mutations. Caution must be applied when seeking to discount on the basis of Likelihood hazardous assume the worst and act accordingly. Fitness relates to the ability of a GMM to spread in vivo or within the community. Modifications to an organism may make a GMM more hazardous but may also render the GMM less fit. It should not be assumed that a GMM is less fit than the parental organism unless there is scientific evidence to support the claim. Assignment of Provisional Class Should consider the pathogenicity of the host i.e. ACDP-1= Level 1 etc. This gives an indication of containment level. Then judgement can be made about whether modification will make GMM more, or less, hazardous and the requirement for a higher or lower level of containment. Only consider for hazard to human health at this stage. Allocation to a particular containment level is dependant on the measures to protect the operator and the environment. These are outlined in Tables 1 4 (see Appendix 1) 5. Section 5: Nature and scale of the activity / review of controls necessary to safeguard human health Section 5 assigned a provisional Class based on identified hazardous properties of the GMM and by comparison with other classification schemes (e.g. ACDP). This relates to the minimal containment level for the GMM and does not take into account the nature of the actual work or detailed consideration of the control measures. Section 5 involves refinement of the appropriate control measures to safeguard human health. Two aspects are considered: a) Whether the nature of the GMM, and especially any uncertainty about its properties, would require any measures in addition to the basic containment level indicated by the provisional class. This is really a check on what you have already done. David Nelson 05/04/02 5

6 b) The nature of the activity to be undertaken e.g. the use of sharps, animals, aerosols, large scale, in vivo versus in vitro for recombination rates etc. This is more important than a) as the nature of the work may have important consequences for the likelihood of exposure and so subsequent control measures. 6. Section 6: Identification of potential harmful effects of the GMM to the Environment and assignment of additional control measures Objective is to determine the probability of harm to the environment arising as a result of escape of organisms from containment, including all possible routes of escape such as waste disposal. This is done by estimating the likelihood of an escape from the containment facility and consequences of such a release, and possible refinement of appropriate control measures (identified earlier for human health) to safeguard the environment. Consideration of possible harm to the environment is considered by the HSE to be equally as important as to human health. Definition of Harm: harm would be caused if populations of microorganisms in one or more ecosystems were affected in terms of number or function of those organisms, or if small numbers of endangered species were under threat. The procedure to follow is similar to that in Section 4 for human health above i.e. Hazard identification Assessment of likelihood of an escape from the containment facility (e.g. laboratory), assuming control measures associated with the provisional containment level assigned for the protection of human health are in place Assessment of consequences of hazards being manifested if the environment is exposed Determination of risk (likelihood X consequence) Management (control) of risk Should consider capacity to survive, establish, disseminate and or displace other organisms. Survival: look at survival in animal gut, soil, water etc. (E.coli K12 can survive up to 7 days in environment). Potential for transfer to other organisms. Even if GMM has limited capacity to survive will this be enough to allow transfer of gene. Stress induced by starvation/adverse conditions may for example increase plasmid transfer rates. Should also consider: Pathogenicity to animals and plants Products of gene expression that could be toxic to other organisms Phenotypic and genetic stability Potential for exposure Characteristics of local environment (urban, etc) Number of organisms potentially released Should also consult the Specified Animal Pathogens Order to determine if your host organism is covered by this legislation (c.f. ACDP for Human Pathogens). The risk table shown above (Section 4) should be used as guide for working out the level of risk associated with a particular operation based on the consequence of the hazard and the likelihood of that hazard being manifest. If all risks are low or effectively zero, then no additional control measures are necessary. If any risk exceeds these levels then additional control measures should be implemented so as to reduce all risks to low or effectively zero David Nelson 05/04/02 6

7 Assignment of the Containment Level and Class (1, 2, 3, or 4) The provisional Class assigned after Section 4 indicates a base level of containment necessary to control risks to human health. It does not, however, take into account the full risk and in particular the nature of the activity and any risks to the environment. Further revision of the provisional Class is to take account of the complete set of containment and control measures identified by for both human health and environmental protection. To decide the correct final classification users should determine what containment and control measures are by to control of the activity. To do this you should compare the selected measures necessary to control to both humans and the environment with the appropriate table of containment measures (see Tables 1 4, Appendix 1) Where this corresponds to a single containment level this will read across directly to give you the activity class; i.e. Level 1 = Class 1; Level 2 = Class 2, etc. Where the measures identified correspond to measures from two different levels of containment the class corresponds to the HIGHER of the levels. The regulations allow for a reduction in control measures from the appropriate containment level where shows that a particular containment measure(s) is not necessary. The person undertaking the activity must provide full justification to not apply a measure(s), supported by, to the competent authority (HSE). However, the full containment level must be applied until written agreement has been received from the HSE. It is especially important to note that classification is dependent on ONLY those containment measures that are shown by the RISK ASSESSMENT to be necessary to protect human health or the environment. Measures that result from convention, convenience or are for product/process protection are NOT relevant to the classification. David Nelson 05/04/02 7

8 7. Section 7: Waste Control Measures Introduction Prior to final discharge / disposal of waste from contained use activities, any risks to humans and the environment associated with any GMO must be removed by use of inactivation methods. Inactivation refers to the complete or partial destruction of GMMs so as to ensure that any contact between the GMMs and humans or the environment is limited to provide a high level of protection to both humans and the environment. Clearly, the degree of kill is related to the level of risk identified by. In the case of GMMs, this refers to material and waste contaminated with GMMs from all containment level activities. The only exception to this is if the user has the explicit agreement of the competent authority (HSE) to dispose of waste without inactivation. The Authority requires evidence that GMMs will not survive to any appreciable extent in the environment and that there are no associated hazards. For more hazardous GMMs, methods giving 100% kill are such as incineration or autoclaving. However, for less hazardous GMMs, methods giving less than 100% kill may be acceptable, such as chemical disinfection which typically gives a 5 log reduction in viability, or % kill. The following guidance indicates the minimal sorts of information that should be included in the risk. Clearly, greater detail is for activities that present a greater level of risk. Class 1 activities GMMs used in Class 1 activities are by definition of no or negligible risk. Therefore the information supplied can be relatively minimal. However, it is important to state clearly the methods used for each category of waste (e.g. autoclaving, disinfection etc.) Degree of Kill : indications of the expected level of kill should be included, but need not be precise. For chemical disinfection this could be in terms of below detectable level, approximately 4 logs reduction in viability etc. The degree of kill for chemical disinfection methods may come from documented and published protocols in the literature. If all waste products are autoclaved then 100% effectiveness can be quoted, although this can only be done when the autoclave has been for the conditions used in the decontamination of GMMs. Validation: it is important to include statements about how methods have been. For example, it should be confirmed that autoclaves have annual validation tests and information about disinfectant use should include statements to the effect that the appropriate concentration and time etc. conditions will be used that coincides with manufacturer s validation. Class 2 activities Similar information should be given as for Class 1 activities (see above). However, if GMMs pose an environmental risk particular care must be taken e.g. if the GMM is a plant pathogen and there are susceptible plants in the local environment. In such cases on site validation of the inactivation methods is and reliance on manufacturer s data would be less acceptable. Where possible the degree of kill expected should be stated more precisely than for Class 1. The use of a and well maintained autoclave is likely to offer the best of inactivation. Testing of cultures after the inactivation process for the presence of viable organisms should be carried out periodically. David Nelson 05/04/02 8

9 Class 3 activities For Class 3 activities most inactivation should be by of an autoclave. You will need to state how this is and monitored. In addition to annual validation using independent, monthly monitoring by of Browns tubes or independent thermologues is. Where there is a particular environmental risk, monitoring of each run must be done. 8. Section 8: Health Surveillance The GMO 2000 Regulations do not include a specific requirement for health surveillance for GM work, but other more general regulations, such as MHSWR and COSHH will be applicable in some cases. The requirements for health surveillance depend whether the genetic modification aspects of the work involve a significant risk to health, as determined by. Health surveillance is appropriate when: an identifiable health effect may be related to exposure there is a reasonable likelihood that the disease or effect may occur under conditions of the work there are valid techniques for detecting indications of the disease or health effect The General COSHH Approved Codes of Practice (ACoP) contains further interpretation on the need for health surveillance, whilst the ACGM Part 1 details different health surveillance mechanisms to be considered. 9. Section 9: Supporting References List all references that have been used to support comments made in. David Nelson 05/04/02 9

10 Appendix 1 For assessors information only There is NO requirement to submit tables with the completed GMM Risk Assessment Table 1: Containment Measures for Activities Involving Genetic Modification of Microorganisms in LABORATORIES Containment Levels 1 Laboratory suite isolation (note1) 2 Laboratory: sealable for fumigation Equipment 3 Surfaces impervious to water, resistant to acids, alkalis solvents, disinfectants and decontamination agents and easy to clean 4 Entry to lab via airlock (Note 2) 5 Negative pressure relative to the pressure of the immediate surroundings 6 Extract and input air from the laboratory shall be HEPA filtered 7 Microbiological safety cabinet/enclosure Containment Measures not not not not for bench for bench for bench and floor not not where not where not not HEPA filters for extract air not where 8 Autoclave on site in the building, and all procedures with infective materials to be contained within a cabinet/ enclosure in the laboratory suite (Note 4) for bench, floor, ceiling and walls HEPA filters for extract and input air (Note 3) Class III cabinet double ended autoclave in the laboratory David Nelson 05/04/02 10

11 System of Work 9 Access restricted to authorised personnel only 10 Specific measures to control aerosol dissemination not (via airlock key procedure) not to minimise to prevent 11 Shower not not where 12 Protective clothing suitable protective clothing suitable protective clothing 13 Gloves not where 14 Efficient control of disease vectors (E.g. rodents and insects) which could disseminate GMM's 15 Inactivation of GMM's in contaminated waste material Waste 16 Inactivation of GMM's in effluent from hand washing sinks, showers and similar effluents 17 Inactivation of GMM's in contaminated material and waste where where suitable protective clothing ; footwear where to prevent complete change of clothing and footwear before entry and exit not not where by by by by David Nelson 05/04/02 11

12 Other Measures 18 Laboratory to contain its own equipment 19 An observation window or alternative is to be present so that occupants can be seen not not, so far as it is reasonable practicable where 20 Safe storage of GMM's where 21 Written records of staff training not where secure storage where NOTES 1. In the Table above, "isolation", in relation to a laboratory, separation of the laboratory from other areas in the same building, or being in a separate building. 2. Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors. 3. Where viruses are not retained by the HEPA filters, extra requirements will be necessary for extract air. 4. Where the autoclave is outside the laboratory in which the activity involving genetic modification of micro-organisms is being undertaken, but within the laboratory suite, there shall be procedures for the safe transfer of material into that autoclave, which provide a level of protection equivalent to that which would be achieved by having an autoclave in that laboratory. David Nelson 05/04/02 12

13 Table 2: Containment Measures for Activities Involving Genetic Modification of Microorganisms in PLANT GROWTH FACILITIES Containment Levels Containment Measures Building Permanent structure (Note 1) Modification Equipment 2 Entry via a separate room with two interlocking doors 3 Control of contaminated run-off water System of Work 4 Efficient control of disease vectors such as insects, rodents and arthropods which could disseminate GMM's 5 Effective control of pollen, seeds and other plant material which could disseminate GMM's 6 Procedures for transfer of living material between the plant growth facilities, protective structure and laboratory shall control dissemination of GMM's where and to extent shows it is not where and to extent shows it is where so as to prevent runoff where so as to prevent runoff (via airlock key procedure) so as to prevent runoff where and to extent shows it is to prevent dissemination to minimise dissemination to prevent dissemination to prevent dissemination to prevent dissemination to prevent dissemination to prevent dissemination David Nelson 05/04/02 13

14 NOTES 1. A permanent structure refers to a fixed structure with walls, a roof and a floor. Where the permanent structure is a greenhouse, that structure shall also have a continuous waterproof covering and self-closing lockable outer doors, and be located on a site designed to prevent the entry of surface run-off water. 2. The terms Modification/ (column 1) refer to whether a particular feature should be considered in addition to or as a modification of the containments considered in Table 1. David Nelson 05/04/02 14

15 Table 3: Containment Measures for Activities Involving Genetic Modification of Microorganisms in ANIMAL UNITS Containment Levels Containment Measures Facilities Isolation of Animal Unit (Note 1) Modification where and to extent shows 2 Animal facilities separated by lockable doors (Note2) 3 Animal facilities (cages etc) designed to facilitate decontamination (waterproof and easily washable material) 4 Floors, walls and ceilings easily washable Modification 5 Appropriate filters on isolators or isolated rooms (Note 3) 6 Incinerator for disposal of animal carcasses 7 Appropriate barriers at room exit and at drains or ventilation duct work. 8 Animals kept in appropriate containment facilities, such as cages, pens, tanks or isolators it is where and to extent shows they are where and to extent shows they are where and to extent shows it is not to be accessible where shows they are for floor where to be accessible for floor and walls to be accessible for floor, walls and ceiling where and to extent shows it is where where NOTES 1. In the Table above, "animal unit" a building, or separate area within a building, containing an animal facility and other areas including changing rooms, showers, autoclaves and food storage areas. 2. In the Table above and in Note 1 above, "animal facility" a facility normally used to house stock, breeding or experimental animals or one which is used for the performance of minor surgical procedures on animals. to be on site where the risk 3. In the Table above, "isolators" transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. David Nelson 05/04/02 15

16 Table 4: Containment Measures for Activities Involving Genetic Modification of Microorganisms in PREMISES OTHER THAN THOSE REFERRED TO IN TABLES 1, 2 AND 3 Containment Levels 1 Viable microorganisms shall be contained in a system which separates the process from the workplace and wider environment (closed system) Containment Measures General where 2 Closed systems located within a controlled area 3 Control of exhaust gases from the closed system 4 Control of aerosols during sample collection, addition of material to a closed system or transfer of material to another closed system 5 Inactivation of bulk culture fluids before removal from closed system 6 Seals shall be designed to minimise or prevent release 7 The controlled area designed to contain spillage of the entire contents of the closed system 8 The controlled area sealable to permit fumigation not not where where not where not 9 Biohazard signs posted where where to minimise release to minimise release by to minimise release where where to prevent release to prevent release by to prevent release where and to be purpose built to prevent release to prevent release by to prevent release David Nelson 05/04/02 16

17 Equipment 10 Entry via airlock not not where 11 Surfaces impervious to water, resistant to acids, alkalis solvents, disinfectants and decontamination agents and easy to clean 12 Specific measures to adequately ventilate the controlled areas in order to minimise air contamination 13 The controlled area maintained at negative pressure relative to the immediate surroundings 14 Extract and input air from the controlled area shall be HEPA filtered System of Work 15 Access restricted to authorised personnel only 16 Decontamination and washing facilities provided for personnel 17 Personnel shall shower before leaving the controlled area 18 Personnel shall wear protective clothing 19 Written procedures and records of staff training for any bench where for any bench where for floor and any bench where not not where not not for extract air, optional for input air for bench, floor, ceiling and walls for input and extract air not not not where work clothing work clothing complete change before exit and entry not not David Nelson 05/04/02 17

18 Waste 20 Inactivation of GMM's in effluent from hand washing sinks and showers or similar effluents 21 Inactivation of GMM's in contaminated material and waste including those in process effluent before final discharge not not where by by by by David Nelson 05/04/02 18

Ministry of Social Affairs and Health, Finland. N.B. Unofficial translation. Legally valid only in Finnish and Swedish. No.

Ministry of Social Affairs and Health, Finland. N.B. Unofficial translation. Legally valid only in Finnish and Swedish. No. Ministry of Social Affairs and Health, Finland N.B. Unofficial translation. Legally valid only in Finnish and Swedish No. 1053/2005 Decree of the Ministry of Social Affairs and Health on principles of

More information

GM Risk Assessment Form 4: Genetically Modified Plants

GM Risk Assessment Form 4: Genetically Modified Plants GM Risk Assessment Form 4: Genetically Modified Plants A GM risk assessment is required for any work involving the possession or use of genetically modified plants and related materials. Please complete

More information

GM Risk Assessment Form 3: Genetically Modified Animals

GM Risk Assessment Form 3: Genetically Modified Animals GM Risk Assessment Form 3: Genetically Modified Animals A GM risk assessment is required for any work involving the possession or use of genetically modified animals and related materials. Please complete

More information

DIRECTIVE 2009/41/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

DIRECTIVE 2009/41/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 21.5.2009 Official Journal of the European Union L 125/75 DIRECTIVES DIRECTIVE 2009/41/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 May 2009 on the contained use of genetically modified micro-organisms

More information

UNIVERSITY OF EXETER

UNIVERSITY OF EXETER UNIVERSITY OF EXETER Risk Assessment Of Genetically Modified Micro-organisms Where The Primary Risk Posed Is To Human Health Rather Than To The Environment This risk assessment form is for use in cases

More information

RISK ASSESSMENT OF GENETICALLY MODIFIED MICRO-ORAGNISMS: A FORMAT THAT OFFERS ONE POSSIBLE WAY OF ACHIEVING GOOD PRACTICE

RISK ASSESSMENT OF GENETICALLY MODIFIED MICRO-ORAGNISMS: A FORMAT THAT OFFERS ONE POSSIBLE WAY OF ACHIEVING GOOD PRACTICE RISK ASSESSMENT OF GENETICALLY MODIFIED MICRO-ORAGNISMS: A FORMAT THAT OFFERS ONE POSSIBLE WAY OF ACHIEVING GOOD PRACTICE 1 Regulation 6 of the Genetically Modified Organisms (Contained Use) Regulations

More information

Official Journal of the European Communities

Official Journal of the European Communities 12.10.2000 EN Official Journal of the European Communities L 258/43 COMMISSION DECISION of 27 September 2000 concerning the guidance notes for risk assessment outlined in AnnexIII of Directive 90/219/EEC

More information

ANNEX III ADDITIONAL GUIDANCE ON SPECIFIC TYPES OF GM WORK

ANNEX III ADDITIONAL GUIDANCE ON SPECIFIC TYPES OF GM WORK ANNEX III ADDITIONAL GUIDANCE ON SPECIFIC TYPES OF GM WORK 1. Work involving the cloning of potentially harmful DNA or prion protein genes should be assessed with respect to the risks posed to human health

More information

CONTAINED USE OF GENETICALLY MODIFIED MICRO-ORGANISMS

CONTAINED USE OF GENETICALLY MODIFIED MICRO-ORGANISMS Statute book of the Swedish National Board of Occupational Safety and health AFS 2000:5 CONTAINED USE OF GENETICALLY MODIFIED MICRO-ORGANISMS Provisions of the Swedish National Board of Occupational Safety

More information

Working with Biological Agents - the basics

Working with Biological Agents - the basics Working with Biological Agents - the basics The following is a discussion of some of the considerations and requirements for researchers intending to work with pathogens and other biological agents. Much

More information

Inspection Checklist for NIH BL3 Laboratories (7 CFR 331; 9 CFR 121; 42 CFR 73; NIH Guidelines)

Inspection Checklist for NIH BL3 Laboratories (7 CFR 331; 9 CFR 121; 42 CFR 73; NIH Guidelines) 12(a) 12(a) 12(b) 12 (c)(3) An individual or entity required to register under this part must develop and implement a written biosafety plan that is commensurate with the risk of the agent or toxin, given

More information

Risk Assessment. GM Safety v4 11/10/2010. Genetic Modification Safety. Objectives Safety Office

Risk Assessment. GM Safety v4 11/10/2010. Genetic Modification Safety. Objectives Safety Office Genetic Modification Safety Objectives Legal requirements for control of genetically modified organisms Risk relating to genetically modified organisms at work Risk assessment and control for genetically

More information

WHO SHOULD FILL THE FORM This page need not be submitted only for reading

WHO SHOULD FILL THE FORM This page need not be submitted only for reading Project Categories WHO SHOULD FILL THE FORM This page need not be submitted only for reading 1) Category I: Routine rdna projects that do not need elaboration: Experiments involving non-pathogenic and

More information

Biological Safety Training

Biological Safety Training Biological Safety Training Thierry Savin October 2017 Introduction Safety First! General philosophy: Take reasonable care of your own safety and others Use equipments, chemicals, bio-agents safely Only

More information

Animal Facility Biosafety Level 3 Checklist (date: April 16, 1998)

Animal Facility Biosafety Level 3 Checklist (date: April 16, 1998) Date: Location: Responsible: Project Title: Inspector: _ Animal Facility Biosafety Level 3 Checklist (date: April 16, 1998) These questions are based on the Biosafety Level 3 section of Biosafety in Microbiological

More information

PART 2E RISK ASSESSMENT OF ACTIVITIES INVOLVING GENETICALLY MODIFIED ANIMALS

PART 2E RISK ASSESSMENT OF ACTIVITIES INVOLVING GENETICALLY MODIFIED ANIMALS PART 2E RISK ASSESSMENT OF ACTIVITIES INVOLVING GENETICALLY MODIFIED ANIMALS Introduction 1. This Part provides guidance on the risk assessment of activities involving genetically modified (GM) animals.

More information

Please refer to The University of Chicago Biosafety Manual for supplementary information about the concepts presented in this training module.

Please refer to The University of Chicago Biosafety Manual for supplementary information about the concepts presented in this training module. 1 Please refer to The University of Chicago Biosafety Manual for supplementary information about the concepts presented in this training module. http://biologicalsafety.uchicago.edu/page/university-chicago-biosafety-manual

More information

Risk Assessment. GM Safety v5 15/11/2010. Genetic Modification Safety. Objectives Safety Office

Risk Assessment. GM Safety v5 15/11/2010. Genetic Modification Safety. Objectives Safety Office Genetic Modification Safety Objectives Legal requirements for work with genetically modified organisms Risk relating to genetically modified organisms at work Risk assessment and control for genetically

More information

Biological Safety Policy

Biological Safety Policy Biological Safety Policy CONTENTS 1. University Policy 1.1 Purpose of the policy 1.2 Scope of the policy 2. Responsibilities of duty holders 2.1 Heads of Departments 2.2 Biological Safety Officer 2.3 Biological

More information

Biological Research Registration Form

Biological Research Registration Form Biological Research Registration Form The University of Oregon requires Institutional Biosafety Committee review and approval of research involving recombinant or synthetic nucleic acids (rsna), organisms

More information

BIOSAFETY LEVEL LABORATORIES

BIOSAFETY LEVEL LABORATORIES BIOSAFETY LEVEL LABORATORIES A. BIOSAFETY LEVEL 1 Biosafety Level 1 (BSL-1) is suitable for work involving well-characterized agents not known to consistently cause disease in immunocompetent adult humans,

More information

University of Delaware Department of Environmental Health & Safety Recombinant DNA Registration

University of Delaware Department of Environmental Health & Safety Recombinant DNA Registration Registration #: University of Delaware Department of Environmental Health & Safety Recombinant DNA Registration Directions: Please complete this form to register recombinant DNA research with the University

More information

GM Project Approval Process How it Works

GM Project Approval Process How it Works GM Project Approval Process How it Works 1. Decide if your work concerns: GM animals, GM human viruses or viral vectors, GM microorganisms other than viruses (but including cell cultures), GM plant viruses,

More information

PI s Name Date Bldg./Rm#

PI s Name Date Bldg./Rm# PI s Name Date Bldg./Rm# Animal Biosafety Level 3 (ABSL-3) Yes No 1. Is access to the animal facility limited or restricted only to those persons authorized for program or support purposes? Yes No 2. Does

More information

The NIH rdna Guidelines Explained

The NIH rdna Guidelines Explained Clemson University IBC Page 1 of 8 The NIH rdna Guidelines Explained The next few pages were written to extract the essence of the NIH guideline requirements and put them into readable form. Since many

More information

University of Lethbridge GUIDELINES FOR USE OF ADENO-ASSOCIATED VIRAL VECTORS (AAV VECTORS)

University of Lethbridge GUIDELINES FOR USE OF ADENO-ASSOCIATED VIRAL VECTORS (AAV VECTORS) GUIDELINES FOR USE OF ADENO-ASSOCIATED VIRAL VECTORS (AAV VECTORS) Abstract All laboratories using AAV vectors must adhere to this code of practice December 2013 Purpose: To provide guidelines for safely

More information

Health, Safety & Environmental Protection Office RESPONSIBILITIES AND ARRANGEMENTS FOR THE SAFE USE OF BIOLOGICAL AGENTS

Health, Safety & Environmental Protection Office RESPONSIBILITIES AND ARRANGEMENTS FOR THE SAFE USE OF BIOLOGICAL AGENTS KING S COLLEGE LONDON Health, Safety & Environmental Protection Office RESPONSIBILITIES AND ARRANGEMENTS FOR THE SAFE USE OF BIOLOGICAL AGENTS Issue Date: Jun 2009 Issue Number: 1 Procedure No: SPR003

More information

The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) Northern Arizona University Office of Regulatory Compliance Shelley Jones, Director of Biological

More information

Working in a Microbiological Laboratory: face-to-face with infectious risk

Working in a Microbiological Laboratory: face-to-face with infectious risk Working in a Microbiological Laboratory: face-to-face with infectious risk V. Siarkou, V. Kyriazopoulou-Dalaina B Laboratory of Microbiology, School of Medicine, Aristotle University, 541 24 Thessaloniki,

More information

Summary Statement of the Asilomar Conference on Recombinant DNA Molecules

Summary Statement of the Asilomar Conference on Recombinant DNA Molecules Summary Statement of the Asilomar Conference on Recombinant DNA Molecules Paul Berg, David Baltimore, Sydney Brenner, Richard O. Roblin, and Maxine F. Singer PNAS 1975;72;1981-1984 doi:10.1073/pnas.72.6.1981

More information

Syracuse University Institutional Biosafety Committee Protocol Application Form

Syracuse University Institutional Biosafety Committee Protocol Application Form Syracuse University Institutional Biosafety Committee Protocol Application Form The Syracuse University Institutional Biosafety Committee (IBC) has been established to protect the health of University

More information

Clinical Laboratory. BioSafety

Clinical Laboratory. BioSafety Clinical Laboratory BioSafety Biosafety Management Laboratory acquired infections, LAI SARS 2003-04: 4 lab staff, 7 secondary cases Ebola 2004: 46-y women, dead, Russia Tb 2004: 3 cases from leaky aerosol

More information

Registration Document For Biohazards

Registration Document For Biohazards Protocol #: Registration Document For Biohazards All applicants are required to complete the following sections: Principal Investigator Information Location of Study Section A: General Administrative Information

More information

National Institutes of Health (NIH)

National Institutes of Health (NIH) Recombinant DNA (rdna) is regulated by the National Institutes of Health (NIH). LCSC, along with all other institutions which use rdna in research, is required to provide training to the researchers who

More information

Inspection Checklist - Animal Pathogen Containment Level 2 Facilities

Inspection Checklist - Animal Pathogen Containment Level 2 Facilities Company/Organization: Applicant's name: Biological Safety Officer s name: Address: Address (If different from precedent): Phone: Phone: Fax: Fax: Email: Email: Building(s) / Room(s) # where material will

More information

IBC protocol Risk Assessment and Determination of NIH Guidelines

IBC protocol Risk Assessment and Determination of NIH Guidelines IBC protocol Risk Assessment and Determination of NIH Guidelines The following are points to consider when reviewing all protocols for risk, recommended containment conditions, and determine applicable

More information

BIOSAFETY REGISTRATION FORM

BIOSAFETY REGISTRATION FORM BRF 5/2015 Page 1 of 5 COMMITTEE USE ONLY 1. PERSONNEL TEMPLE UNIVERSITY Office of the Vice Provost for Research Division of Research Compliance Institutional Biosafety Committee Tel: (215) 707-9741, Fax:

More information

BIOHAZARD RISK ASSESSMENT

BIOHAZARD RISK ASSESSMENT BIOHAZARD RISK ASSESSMENT NAME: DATE: TITLE OF ACTIVITY OR PROJECT: BRIEF DESCRIPTION OF THE BIOLOGICAL AND ITS TREATMENT: DURATION OF ACTIVITY OR PROJECT: FACILITY TO BE USED (Campus, Building and Room

More information

Safe Operating Procedure

Safe Operating Procedure Safe Operating Procedure RECOMBINANT OR SYNTHETIC NUCLEIC ACIDS IBC AND OTHER REVIEW REQUIREMENTS (For assistance, please contact EHS at (402) 472-4925, or visit our web site at http://ehs.unl.edu/) (Revised

More information

Biological Safety and Biosecurity

Biological Safety and Biosecurity OHSS: H&S Management Stard 301 Biological Biosecurity Biological Biosecurity 1. Legal framework This policy is produced to ensure compliance with; 1.1. the Health at Work Act 1974; 1.2. the Management

More information

Guidelines for Certification. Physical Containment Level 2 Plant Facility

Guidelines for Certification. Physical Containment Level 2 Plant Facility Guidelines for Certification of a Physical Containment Level 2 Plant Facility Version 3.2 Effective 1 March 2013 The guidelines (Part A) contain the requirements for certification of a Physical Containment

More information

Skidmore College Institutional Biosafety Committee (IBC) Protocol Registration Form

Skidmore College Institutional Biosafety Committee (IBC) Protocol Registration Form Skidmore College Institutional Biosafety Committee (IBC) Protocol Registration Form Please return completed form to Loretta Greenholtz, 424 Palamountain Hall. IBC Reg. No: Risk Group: General Instructions:

More information

The SACGM Compendium of guidance Part 2: Risk assessment of genetically modified microorganisms (other than those associated with plants)

The SACGM Compendium of guidance Part 2: Risk assessment of genetically modified microorganisms (other than those associated with plants) Heading/title Health and Safety Executive The SACGM Compendium of guidance Part 2: Risk assessment of genetically modified microorganisms (other than those associated with plants) HSE Books Table of contents

More information

BIO-SAFETY IN MICROBIOLOGIC AND BIOMEDICAL LABORATORIES. Dr. K. P. Narkhede

BIO-SAFETY IN MICROBIOLOGIC AND BIOMEDICAL LABORATORIES. Dr. K. P. Narkhede BIO-SAFETY IN MICROBIOLOGIC AND BIOMEDICAL LABORATORIES Dr. K. P. Narkhede PRINCIPLES OF BIOSAFETY This lesson will define and present information on methods used to provide biosafety in facilities where

More information

Regulatory Requirements for Use of Transgenic Plants in the Greenhouse

Regulatory Requirements for Use of Transgenic Plants in the Greenhouse Regulatory Requirements for Use of Transgenic Plants in the Greenhouse Agenda Introduction Biosafety Levels Containment Frank A. Cantone, Ph.D., CBSP Biological Safety Officer Environmental Health & Safety

More information

Adopted 39 th AMAF Meeting (28/9/2017) PROTOCOL FOR RECOGNITION OF ASEAN REFERENCE LABORATORIES FOR ANIMAL VACCINE TESTING

Adopted 39 th AMAF Meeting (28/9/2017) PROTOCOL FOR RECOGNITION OF ASEAN REFERENCE LABORATORIES FOR ANIMAL VACCINE TESTING Adopted 39 th AMAF Meeting (28/9/2017) PROTOCOL FOR RECOGNITION OF ASEAN REFERENCE LABORATORIES FOR ANIMAL VACCINE TESTING CONTENT INTRODUCTION - APPLICATION FOR RECOGNITION - ENDORSEMENT OF APPLICATION

More information

Guidelines for Certification. Physical Containment Level 2 Aquatic Facility

Guidelines for Certification. Physical Containment Level 2 Aquatic Facility Guidelines for Certification of a Physical Containment Level 2 Aquatic Facility Version 3.1 Effective 1 March 2013 The guidelines (Part A) contain the requirements for certification of a Physical Containment

More information

Calvin College Biosafety Application

Calvin College Biosafety Application SECTION 1: GENERAL INFORMATION Calvin College Biosafety Application Applicant Name: Campus Address: Email Address: Campus Phone #: Project Title: APPLICATION TYPE: Research Teaching Course #(s) PROTOCOL

More information

Vertebrate Animal Biosafety Level 2 Criteria

Vertebrate Animal Biosafety Level 2 Criteria Vertebrate Animal Biosafety Level 2 Criteria Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5 th Edition Section V Animal Biosafety Level 2 (ABSL-2): Animal Biosafety Level 2 builds upon

More information

Guidelines for Certification. Physical Containment Level 2 Invertebrate Facility

Guidelines for Certification. Physical Containment Level 2 Invertebrate Facility Guidelines for Certification of a Physical Containment Level 2 Invertebrate Facility Version 3.1 Effective 1 March 2013 The guidelines (Part A) contain the requirements for certification of a Physical

More information

INTERNATIONAL STANDARDS FOR PHYTOSANITARY MEASURES

INTERNATIONAL STANDARDS FOR PHYTOSANITARY MEASURES INTERNATIONAL STANDARDS FOR PHYTOSANITARY MEASURES ISPM 34 DESIGN AND OPERATION OF POST-ENTRY QUARANTINE STATIONS FOR PLANTS (2010) FAO 2010 Design and operation of post-entry quarantine stations for plants

More information

BIOSAFETY REGISTRATION FORM

BIOSAFETY REGISTRATION FORM BRF 10/2015 Page 1 of 6 COMMITTEE USE ONLY IBC REGISTRATION # Research Compliance Institutional Biosafety Committee Tel: (215) 707-9741, Fax: (215) 707-9100, Email: ibc@temple.edu research.temple.edu/research-compliance

More information

What goes into my Biological Inventory?

What goes into my Biological Inventory? What goes into my Biological Inventory? What Information is Required for an Effective Risk Assessment? According to the Laboratory Biosafety Guidelines (2004), the risk group of an organism is determined

More information

COMMITTEE USE ONLY IBC REGISTRATION

COMMITTEE USE ONLY IBC REGISTRATION BRF September 2016 Page 1 of 6 COMMITTEE USE ONLY IBC REGISTRATION # ASSOCIATED ACUP/IRB# Research Integrity and Compliance Institutional Biosafety Committee APPROVAL BIOSAFETY REGISTRATION FORM Tel: (215)

More information

DUQUESNE UNIVERSITY. Biosafety Guidelines

DUQUESNE UNIVERSITY. Biosafety Guidelines DUQUESNE UNIVERSITY Biosafety Guidelines Prepared by: Environmental Health and Safety Department TABLE OF CONTENTS Page Biosafety Guidelines 1 Biosafety Guidelines for PIs 2 Biosafety Levels 3 SOP Biohazardous

More information

DUQUESNE UNIVERSITY. Biosafety Guidelines

DUQUESNE UNIVERSITY. Biosafety Guidelines DUQUESNE UNIVERSITY Biosafety Guidelines Prepared by: Environmental Health and Safety Department TABLE OF CONTENTS Page Biosafety Guidelines 1 Biosafety Guidelines for PIs 2 Biosafety Levels 3 SOP Biohazardous

More information

Touro University of California Mare Island, Vallejo

Touro University of California Mare Island, Vallejo Touro University of California Mare Island, Vallejo Institutional Biosafety Committee INITIAL REVIEW FORM Date Received: For IBC use only: Exempt Approved Approved with contingency(ies) Revisions required

More information

Biosafety Level 2 (BSL-2) Laboratory Guidelines

Biosafety Level 2 (BSL-2) Laboratory Guidelines Biosafety Level 2 (BSL-2) Laboratory Guidelines Table of Contents 1. Introduction... 2 2. Required Document for BUA Application Process... 2 3. Training... 2 4. Signage... 2 5. Transporting Biohazardous

More information

REGISTRATION DOCUMENT FOR RECOMBINANT & SYNTHETIC DNA RESEARCH

REGISTRATION DOCUMENT FOR RECOMBINANT & SYNTHETIC DNA RESEARCH IBC Date Received: Reg. Doc. No.: REGISTRATION DOCUMENT FOR RECOMBINANT & SYNTHETIC DNA RESEARCH Principal Investigator: --------------------------------------- Position Title: -------------- Department:

More information

Biosafety Level 2 Criteria Based on Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition

Biosafety Level 2 Criteria Based on Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition Biosafety Level 2 Criteria Based on Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition Biosafety Level 2 (BSL-2): Biosafety Level 2 builds upon BSL-1. BSL-2 is suitable for work

More information

GVSU BIOSAFETY APPLICATION

GVSU BIOSAFETY APPLICATION SECTION 1: GENERAL INFORMATION GVSU BIOSAFETY APPLICATION Applicant Name: Campus Address: Email Address: Campus Phone #: Project Title: APPLICATION TYPE: Research Teaching Course #( s) PROTOCOL TYPE: New

More information

Recombinant or Synthetic Nucleic Acid Molecules

Recombinant or Synthetic Nucleic Acid Molecules Overview of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules A scientificallyresponsive

More information

Yale University Biological Safety Committee

Yale University Biological Safety Committee EHS Use Only Protocol#: Yale University Biological Safety Committee Send original to: Yale Environmental Health and Safety Occupational Health and Safety Section 135 College Street, Suite 100 New Haven,

More information

Minimum Safety Equipment. Standard microbiological practices Sink Required

Minimum Safety Equipment. Standard microbiological practices Sink Required Biosafety Level Description of Agents Required Lab Practices Minimum Safety Equipment Primary Facility 1 Not known to cause disease in healthy adults Standard microbiological practices None required Open

More information

REGISTRATION DOCUMENT FOR RECOMBINANT DNA RESEARCH

REGISTRATION DOCUMENT FOR RECOMBINANT DNA RESEARCH EHRS Date Received: Reg. Doc. No.: REGISTRATION DOCUMENT FOR RECOMBINANT DNA RESEARCH Principal Investigator: Penn ID#: Position Title: School: Department: Mailing Address: Mail Code: Telephone: FAX: E-mail:

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS NOTE FOR GUIDANCE 1 : DNA VACCINES NON-AMPLIFIABLE IN EUKARYOTIC CELLS FOR VETERINARY USE

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS NOTE FOR GUIDANCE 1 : DNA VACCINES NON-AMPLIFIABLE IN EUKARYOTIC CELLS FOR VETERINARY USE The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Veterinary Use CVMP/IWP/07/98-FINAL COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS NOTE FOR GUIDANCE 1 : DNA VACCINES

More information

Page 1 of 13 MOUTH DISEASE VIRUS AND/OR ITS DERIVATIVES

Page 1 of 13 MOUTH DISEASE VIRUS AND/OR ITS DERIVATIVES PROPOSAL: MINIMUM REQUIREMENTS FOR THE MANAGEMENT OF BIOLOGICAL RISK AND BIOSAFETY IN LABORATORIES HANDLING THE FOOT-AND-MOUTH DISEASE VIRUS AND/OR ITS DERIVATIVES (following COSALFA 43 Resolution No 2,

More information

Scott & White Healthcare Institutional Biosafety Committee (IBC) IBC Study Update / Change Request

Scott & White Healthcare Institutional Biosafety Committee (IBC) IBC Study Update / Change Request Scott & White Healthcare Institutional Biosafety Committee (IBC) IBC Study Update / Change Request 1 Submit the renewal electronically via email attachment to: IBCOFFICE@swmail.sw.org 2 Fax a Signed copy

More information

Application for Research Involving Biological Materials and Recombinant DNA

Application for Research Involving Biological Materials and Recombinant DNA BATES COLLEGE Institutional Biosafety Committee Application for Research Involving Biological Materials and Recombinant DNA INSTRUCTIONS: All submissions must be typed. E-mail completed applications to

More information

VIII. Biosafety Laboratory Practices and Equipment

VIII. Biosafety Laboratory Practices and Equipment VIII. Biosafety Laboratory Practices and Equipment All laboratory personnel shall engage in good microbiological laboratory practices at all times. The following practices incorporate minimal practices

More information

Dr. M. Tariq Javed. Biohazard Biosafety in Biomedical Laboratories. Biosafety definition. Biorisk definition

Dr. M. Tariq Javed. Biohazard Biosafety in Biomedical Laboratories. Biosafety definition. Biorisk definition Biohazard Biosafety in Biomedical Laboratories Dr. M. Tariq Javed Department of Pathology Faculty of Veterinary Science, University of Agriculture Faisalabad. An agent of biological origin that can cause

More information

MICROBIOLOGICAL SAFETY RULES

MICROBIOLOGICAL SAFETY RULES MICROBIOLOGICAL SAFETY RULES Revised October 2008 These rules were approved by the Biological Hazards and Genetic Modification Committee MICROBIOLOGICAL SAFETY RULES CONTENTS 1. Applicability 2. Mandatory

More information

Biosafety Training. WVU Shared Research Facilities 2012

Biosafety Training. WVU Shared Research Facilities 2012 Biosafety Training WVU Shared Research Facilities 2012 Training Overview DEFINE Biosafety, Biohazard, Biosafety Levels Protection (PPE, biosafety cabinets) CELL CULTURE Hazards (Blood Borne Pathogens)

More information

Animal cell and tissue culture. Lab 1

Animal cell and tissue culture. Lab 1 Animal cell and tissue culture Lab 1 Tissue culture Laboratory Safety Outline Lab Safety Biohazards Biosafety Levels Biosafety Cabinets Decontamination Biological Waste Introduction A cell culture laboratory

More information

ENHANCED CONTAINMENT CL2 + (Level 3 practices in a Level 2 lab)

ENHANCED CONTAINMENT CL2 + (Level 3 practices in a Level 2 lab) ENHANCED CONTAINMENT CL2 + (Level 3 practices in a Level 2 lab) The use of Containment Level 3 (CL3) practices and procedures (as listed below) in a Containment Level 2 lab (often referred to as CL2+ ),

More information

MATERIAL SAFETY DATA SHEET

MATERIAL SAFETY DATA SHEET MATERIAL SAFETY DATA SHEET Nucleic Acids (DNA, RNA and cdna) Material Safety Data Sheet for: Nucleic acids, DNA, RNA and cdna, derived from cell cultures supplied by the Culture Collections of Public Health

More information

Basic Biosafety. PERSEUS Biosafety and Biotechnology Regulatory Services. 25 May Dr. Patrick Rüdelsheim General Partner, Perseus BVBA

Basic Biosafety. PERSEUS Biosafety and Biotechnology Regulatory Services. 25 May Dr. Patrick Rüdelsheim General Partner, Perseus BVBA Basic Biosafety 25 May 2011 Dr. Patrick Rüdelsheim General Partner, Perseus BVBA Purpose of the training To provide a general overview of biosafety issues and practices To reinforce a common understanding

More information

General Guidelines on Research Projects Involving Lentivirus

General Guidelines on Research Projects Involving Lentivirus General Guidelines on Research Projects Involving Lentivirus 1. Introduction Lentiviruses comprise a genus of the Retroviridae family and include bovine lentiviruses (e.g., Bovine immunodeficiency virus,

More information

CDC Import Permit Inspection Checklist for Arthropod Containment Level 2 (ACL-2)

CDC Import Permit Inspection Checklist for Arthropod Containment Level 2 (ACL-2) CDC Import Permit Inspection Checklist for Arthropod Containment Level 2 (ACL-2) Street Address: City, State, Zip: Lead Inspector: Other Inspectors: Building/Room(s): PI(s): CFR: 71.54 (b) CFR: 71.54 (b)(1)

More information

National Institutes of Health (NIH) Office of Science Policy (OSP) Recombinant or

National Institutes of Health (NIH) Office of Science Policy (OSP) Recombinant or This document is scheduled to be published in the Federal Register on 04/15/2016 and available online at http://federalregister.gov/a/2016-08810, and on FDsys.gov [Billing Code 4140-01-P] DEPARTMENT OF

More information

Safe working with arthropods Containment and control for work with uninfected, infected and transgenic animals in research

Safe working with arthropods Containment and control for work with uninfected, infected and transgenic animals in research Safe working with arthropods Containment and control for work with uninfected, infected and transgenic animals in research Note: Edition 1 covers containment of flying species only. Introduction 1. Appropriate

More information

Scott & White Healthcare Institutional Biosafety Committee (IBC) IBC Initial Application

Scott & White Healthcare Institutional Biosafety Committee (IBC) IBC Initial Application Scott & White Healthcare Institutional Biosafety Committee (IBC) IBC Initial Application 1 Submit the renewal electronically via email attachment to: IBCOFFICE@swmail.sw.org 2 Submit the Investigator s

More information

Laboratory Research Ethics, Conduct and Safety

Laboratory Research Ethics, Conduct and Safety Laboratory Research Ethics, Conduct and Safety Biohazards and Biosafety Guidelines & Standards Human Pathogens Public Health Agency of Canada Canadian Food Inspection Agency Animal Pathogens Definition:

More information

Activities Involving the Use of External Fermentors

Activities Involving the Use of External Fermentors New Substances program Advisory Note 2016-01 Advice to stakeholders working with micro-organisms within a contained facility under the New Substances Notification Regulations (Organisms) The purpose of

More information

MATERIAL SAFETY DATA SHEET

MATERIAL SAFETY DATA SHEET MATERIAL SAFETY DATA SHEET Growing Cell Cultures Material Safety Data Sheet for: Public Health England (PHE) growing cell cultures Review date: 30 April 2017 Issued to: Access: Users of PHE growing cell

More information

December 2009 CDC-NIH

December 2009 CDC-NIH December 00 CDC-NIH Guidelines for Biosafety Laboratory Competency, CDC and the Assocation of Public Health Laboratories, CDC MMWR Supplement/Vol. 60 April, 0 PI: BSL BMBL th Edition CDC-NIH Dec. 00 N/A

More information

REQUEST TO USE INFECTIOUS AGENTS Yale Biological Safety Committee

REQUEST TO USE INFECTIOUS AGENTS Yale Biological Safety Committee EHS Protocol #: Send original to: Yale Environmental Health and Safety 135 College Street, Suite 100 New Haven, CT 06510 Phone Fax: 203-785-7588 REQUEST TO USE INFECTIOUS AGENTS Yale Biological Safety

More information

UNIVERSITY OF NEVADA LAS VEGAS BSL-2 LABORATORY STANDARD OPERATING PROCEDURES (SOPS)

UNIVERSITY OF NEVADA LAS VEGAS BSL-2 LABORATORY STANDARD OPERATING PROCEDURES (SOPS) UNIVERSITY OF NEVADA LAS VEGAS BSL-2 LABORATORY STANDARD OPERATING PROCEDURES (SOPS) This SOP document should include specific information for the laboratories and procedures being performed. It is meant

More information

Registration for the Use of Biological Materials

Registration for the Use of Biological Materials Form 01: Please return to: Registration for the Use of Biological Materials Environmental Health and Safety (EHS) 135 College St., Suite 100 Tel. 737-2121 Fax 785-7588 OEHS Use Only BSL: BBP State Select

More information

Standards for Safety Assessments of Food Additives produced Using Genetically Modified Microorganisms

Standards for Safety Assessments of Food Additives produced Using Genetically Modified Microorganisms Standards for Safety Assessments of Food Additives produced Using Genetically Modified Microorganisms (Food Safety Commission Decision of March 25, 2004) Chapter 1 General Provisions No. 1 Background on

More information

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 10.03.2006 ENTR/F2/ KK D(2006) NOTICE TO APPLICANTS VETERINARY MEDICINAL PRODUCTS GUIDANCE ON ENVIRONMENTAL

More information

The genetically modified maize is proposed to be used as any other maize.

The genetically modified maize is proposed to be used as any other maize. Opinion of the Scientific Committee on Plants Regarding "Submission for Placing on the Market of Glufosinate Tolerant Corns ( Zea Mays) Transformation Event T25" by the Agrevo Company (NOTIFICATION C/F/95/12/07)

More information

Lab Work Safety Awareness Presented by: Joseph Vincelli Operations Manager

Lab Work Safety Awareness Presented by: Joseph Vincelli Operations Manager Lab Work Safety Awareness Presented by: Joseph Vincelli Operations Manager Mission Statement To support the continuous improvement of the University s safety culture by providing advice, guidance, training,

More information

Laboratory Research Conduct & Safety: Biohazards and Biosafety. Environmental Health & Safety

Laboratory Research Conduct & Safety: Biohazards and Biosafety. Environmental Health & Safety Laboratory Research Conduct & Safety: Biohazards and Biosafety Regulations Public Health Agency of Canada Canadian Food Inspection Agency Human Pathogens Animal Pathogens 2010: Containment Standards for

More information

Lab Biosafety Self-Audit Form (Applies to all microbial work.)

Lab Biosafety Self-Audit Form (Applies to all microbial work.) Principal Investigator: Lab Biosafety Self-Audit Form (Applies to all microbial work.) Office Phone#: Lab Location: Lab Phone #: Person Completing Audit: Date: Type Of Biological Material Used Human samples

More information

ANNEX 5 MANUFACTURE OF IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS

ANNEX 5 MANUFACTURE OF IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS ANNEX 5 MANUFACTURE OF IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS Principle The manufacture of immunological veterinary medicinal products has special characteristics which should be taken into consideration

More information

Laboratory Research Conduct & Safety: Biohazards and Biosafety. Environmental Health & Safety

Laboratory Research Conduct & Safety: Biohazards and Biosafety. Environmental Health & Safety Laboratory Research Conduct & Safety: Biohazards and Biosafety www.mcgill.ca/ehs/laboratory/biosafety/manual Regulations Human Pathogens Public Health Agency of Canada Canadian Food Inspection Agency Animal

More information

Biological Agent Risk Assessment

Biological Agent Risk Assessment Biological Agent Risk Assessment 1. Introduction This guidance is provided to help you carry out biological agent (BA) risk assessments and control the risks of the work to protect humans, animals, plants

More information

Chapter 9 Genetic Engineering

Chapter 9 Genetic Engineering Chapter 9 Genetic Engineering Biotechnology: use of microbes to make a protein product Recombinant DNA Technology: Insertion or modification of genes to produce desired proteins Genetic engineering: manipulation

More information

Instructions for Biosafety Application Research and Sponsored Programs 201J University Hall Wright State University Dayton, OH (937)

Instructions for Biosafety Application Research and Sponsored Programs 201J University Hall Wright State University Dayton, OH (937) Instructions for Biosafety Application Research and Sponsored Programs 201J University Hall Wright State University Dayton, OH 45435 (937) 775-2425 Please use the attached application for requesting a

More information