Regulations on the contained use of genetically modified microorganisms.
Date FOR-2001-12-21-1600
Ministry of Health and Care Services
Published in 2001 Booklet 17
Commencement 01.01.2002
Edited
Changes
FOR 1994-02-11-126, TO-1994-02-11-127
For
Norway
Legal
LOV-1993-04-02-38-section 6, LOV-1993-04-02-38-§7
Promulgated
10/01/2002
Corrected 01.08.2002, 18.01.2008 (Annex 1C and 1D, table headers)
Short Title
Regulations on genetically modified organisms (GMOs)
Chapter Overview:
Chap. 1. General provisions (§§ 1-4)
Chap. 2. Assessment and classification of operations (§§ 5-6)
Chap. 3. Approval of laboratories and facilities (§§ 7-9)
Chap. 4. Notification and approval of contained use (§§ 10-14)
Chap. 5. Preventive measures and control (§§ 15-19)
Chap. 6. Duty of disclosure, procedures etc. (§§ 20-22)
Chap. 7. Commencement (§23)
Annex I A. Application for approval of laboratories and facilities for contained use of genetically modified micro-organisms in laboratory scale
Annex I B. Applications for approval of laboratories and facilities for contained use of genetically modified microorganisms large scale and production
Annex I C. Confinement measures and other protective measures for laboratory activities
Annex I D. Confinement measures and other control measures for production / large scale business
Annex I E. Applications for approval of laboratories and facilities for contained use of genetically modified microorganisms in combination with animal
Annex I F. containment measures activity with genetically modified microorganisms in combination use with animals
Annex II A. Message / application for approval of contained use of genetically modified microorganisms
Annex II B. Records / application for approval of contained use of animals in combination with genetically modified microorganisms
Appendix III. Principles to be followed for the assessment referred to in § 5
Annex IV. Guiding notes on risk assessment referred to in Annex III
Appendix V. General safety
Stipulated by Royal Decree. December 21, 2001 pursuant to the Law of 2 April 1993 no. 38 on the production and use of genetically modified organisms (Gene Technology Act) § 6 and § 7, ref. EEA Agreement Annex XX (Directive 90/219 / EEC, Directive 98 / 81 / EC and decision 2000/608 / EC). Promoted by Health and Social Affairs.
Chap. 1. General Provisions
§ 1. Scope These regulations apply to all the contained use of genetically modified microorganisms unless its use is regulated by other regulations. Regulations governing notification and requirements for approval of the contained use. The regulation also regulates the approval of laboratories and facilities to such use.
§ 2. Definitions In this regulation:
A)
Microorganism, any cellular or non-cellular microbiological entity which is capable of reproduction or of transferring genetic material, including viruses, viroids, animal and plant cells in culture,
B)
Genetically modified microorganism (GMM), a microorganism whose genetic composition has been altered by means of gene or cell technology
C)
Contained use, any operation in which genetically modified organisms are produced, grown, stored, destroyed, or otherwise used, in a closed system in which physical containment measures, possibly in combination with other specific containment measures, to limit their contact with humans and the environment so that these ensured a high level of security,
D)
Accident, any incident involving accidental release of GMM for contained use, and which may cause immediate or subsequent danger to human and / or animal health and / or environment,
E)
Use, any natural or legal person responsible for the contained use of GMM,
F)
Message / application, submission of the information required by the competent authority
G)
Genetic engineering techniques that involve genetic isolation, characterization, modified and inserted into living cells or viruses,
H)
Cell technology techniques for the preparation of live cells with novel combinations of genetic material by the fusion of two or more cells,
I)
Combination use, the contained use of genetically modified microorganisms in combination with animals and plants.
§ 3. Approval Authority Approval Authority is the Ministry or its authorized.
§ 4. Responsibility Responsible for laboratory or facility seeking approval of laboratories or facilities, cf. Sec. 3. This responsibility includes containment measures, security and control, cfr. Ch. 3 and 5. shall be kept, and the shall upon request be made available to the supervisory authority.
User is responsible for pre-assessment and notification or application for approval of the contained use, cf. Sec. 4. User responsibility also includes checking that the contained use is in accordance with the regulations and the approval given. It shall be kept of the contained use, and the Protocol shall upon request be made available to the supervisory authority.
Chap. 2. Valuation and classification of business
§ 5. Preliminary assessment of risk The user must make a prior assessment of the contained use with regard to risk of illness / injury to humans, animals, plants or the environment that this use might entail. The pre-assessment includes all types of business, and is essential for the containment level and with the containment activities can take place, cfr. Ch. 3
User shall as a minimum use the evaluation items and the procedure set out in Annex III with guidance notes in Annex IV.
A summary of the pre-assessment must accompany the notification / application for approval for operations in Class 1 and 2 ref. § 10. The pre-assessment must accompany the application for approval for operations in Class 3 and 4, ref. § 11.
§ 6. Classification of business On the basis of pre-assessment referred to in § 5 shall use classify business into four classes, with associated containment levels in accordance with Sec. 3:
Class 1:
business that does not involve risk or negligible risk, ie activities where containment measures at containment level 1 is appropriate to protect human and animal health and the environment.
Class 2:
business that involves little risk, ie activities where containment measures at containment level 2 is appropriate to protect human and animal health and the environment.
Class 3:
business that involves moderate risk, ie activities where containment measures at containment level 3 is appropriate to protect human and animal health and the environment.
Class 4:
business that involves great risk, ie activities where containment measures at containment level 4 is appropriate to protect human and animal health and the environment.
Chap. 3. Approval of laboratories and facilities
§ 7. Approval of laboratories and facilities Laboratories and equipment to be used for contained use, must be approved before the start of activities.
Applications for approval of laboratories and facilities submitted on special application ref. Annex IA, IB and I E. In combination use with plants, the containment measures combined with the requirements of the regulations on the contained use of genetically modified plants. In combination with the use of genetically modified animals shall containment measures combined with the requirements of the regulations on genetically modified animals. The application may be submitted with the notification or application for approval of the contained use (Annex II A and II B).
Approval Authority shall obtain the opinion of other relevant authorities where the planned nature of the business requires.
Approval of laboratory containment level 1 and 2 shall be submitted within 45 days and other approval shall be submitted within 90 days. Deviations from these time limits specified in § 22.
§ 8. Requirements for containment level laboratories and plants classified in containment level 1, 2, 3 and 4, where 1 is the lowest containment level. Minimum containment seen in table in Annex IV of at F. In certain cases it may be necessary to use a combination of measures from the tables.
If there is doubt about the containment level and containment measures that are appropriate to a planned contained use, the more stringent protective measures applied unless sufficient evidence, in agreement with the competent authority, making it eligible to apply less stringent measures.
For laboratories and facilities in all containment levels shall viable microorganisms least entrapped in a system which physically separates them from the environment (closed system).
Laboratory and plant to be fit for purpose, equipped and furnished to the functions and operations to be performed so that the workplace and the environment are exposed to the lowest feasible level of GMM and so high security is guaranteed.
§ 9. Amendment of laboratory / facility If significant changes in the lab / facility, notification of the change sent the approval authority.
If the change results in an expansion of the plant, affecting containment level or other approved containment or safety, must be submitted a new application for approval. The change can not be used until new approval is granted.
Chap. 4. Notification and approval of contained use
§ 10. Activities which require notification At undertakings contained use of GMM in class 1 and 2 which do not require approval under § 11 letter a shall be submitted notification on a standard form, Annex II A and II B before it can commence . All biological experiments on animals covered by the Act of 20 December 1974 nr 73. Animal Welfare § 21, to be approved by this before operations can commence.
§ 11. Activities which require approval following business requires written approval before it can commence:
A)
transfer of human genetic material to microorganisms, which does not happen in research or experiments to sequence the genetic fabric structures, properties and functions
B)
all the contained use of genetically modified micro-organisms in class 3 and 4.
Prior approval is required each time new such activities will be conducted.
All biological experiments on animals covered by the Act of 20 December 1974 nr 73. Animal Welfare § 21, to be approved by this before operations can commence.
Applications should be submitted on the prescribed form, Appendix II A and II B.
If laboratory / facility previously received approval for the appropriate containment level, the processing time 45 days. Otherwise approval deadline is 90 days. Deviations from these deadlines specified in § 22.
§ 12. Notification and approval of contained use when the approval authority has received a message or application shall investigate whether
1)
messages / applications are in accordance with the requirements of the regulations,
2)
about the information given is accurate and complete,
3)
pre-assessment and the class of contained use are correct
4)
containment measures, other control measures and waste and emergency measures are sufficient.
If necessary, the competent authority may ask the user to provide additional information or to change the circumstances surrounding the proposed contained use or modify the class that the contained use is in. In that case, the competent authority may require that the contained use does not commence if the is scheduled, or set temporarily or terminated if it is running, the competent authority has given its approval on the basis of the received additional information or changes of circumstances surrounding the contained use.
When the approval authority has received the information necessary for the information and opinions to be accepted as complete and correct, the approval authority shall notify report or apply that a complete notification or application is received.
If the competent authority subsequently receives information that could have a significant impact on the risks associated with the contained use, the competent authority may require the user to modify the conditions of the contained use, suspend it temporarily or end it.
Approval Authority shall obtain the opinion of other relevant authorities where the planned nature of the business requires. Approval Authority may submit the application for recognition of the Biotechnology Council for review and comment before a decision is made. If the approval authority finds it appropriate, it may decide that the public shall be consulted on aspects of the proposed contained use.
Approval Authority may limit the period for which the contained use is permitted or prescribe special conditions for it.
§ 13. Social and ethical considerations when applying for approval in accordance with § 11 a of the applicant shall enclose a special assessment of the social and ethical aspects of business.
The assessment should include a balance between the benefits and the impacts humans, animals, plants and the environment are exposed. The purpose of the activity will be evaluated separately. The assessment will form the basis for approving the government's treatment of the application.
By application where there is no approval by the Animal Welfare Act § 21 the application must include a balance between utility and the loads the animal is exposed to, including the animals' integrity, instincts and welfare.
The purpose of the business and ethical aspects beyond that animal welfare should be assessed separately. The assessment shall be included in the application, see. Stipulated application form, and this will form the basis for approving the government's treatment of the application.
§ 14 Changes in the business event of significant changes in operations, notification of the change sent the approval authority.
If the change has implications for risk, the scope and requirements of the containment measures, shall be sent new message / application for approval.
Chap. 5. Preventive measures and control
§ 15. Measures In all contained uses the principle of good microbiological practice. The security measures shall be in accordance with Annex V.
Genetically modified microorganisms must be inactivated using recognized methods in all waste and emissions, including wastewater. It should if necessary be examined if there is any viable organisms outside the primary physical containment.
In addition to the requirements of subsection shall all emissions into the environment, where it used antibiotic resistance genes, treated so that these genes are destroyed for example by fragmentation.
The effect of treatment in second and third paragraphs shall be documented.
§ 16. Control Responsible for laboratory / facility shall supervise the contained use. The assessment in § 5 and containment and other protective measures applied including storage and handling of waste should be revised regularly and immediately if:
A)
containment measures applied are no longer adequate or the class that the contained use is located, is no longer correct, or
B)
there is reason to believe that the assessment is no longer satisfying, in the light of new scientific or technical knowledge.
§ 17. Supervisory authority Ministry or the Ministry appoints shall supervise compliance with the provisions of these regulations are complied with.
§ 18. Contingency plan before contained use begins, the supervisory authority shall ensure
A)
the preparation of a contingency plan for contained use, in case of failure of the containment measures immediately or later can lead to serious danger for people and animals outside the facility and / or the environment, except where such a contingency plan has been prepared in according to other relevant regulations,
B)
that bodies and authorities that can be touched by accident, in an appropriate manner and are receiving unsolicited information on such emergency plans, including the relevant safety measures to be implemented. The information shall be updated at regular intervals. They shall also be made available to the public.
In preparing the contingency plan by letter a supervisory authority consult with regulators in other states that may be affected in case of accident, the proposed implementation of the emergency plan.
The information in letter b shall also be made available to other states that may be affected by the incident.
Users are obliged to provide details of the emergency plan. Requirements for such information stated in the application form ref. Annex II.
§ 19. Accidents In case of an accident, the user shall immediately notify the supervisory authority. The following information must be provided:
-
The detailed circumstances of the accident,
-
Identity and amount of GMM which is discharged
-
All information necessary to assess the accident effects on health and environment,
-
What measures have been taken.
When providing such information, the authorities shall
-
Ensure that all necessary measures are taken and promptly notify authorities of all States which may be affected by the incident,
-
If possible collect the information necessary for a complete analysis of the incident, and possibly recommend measures to avoid similar accidents in the future and to limit their effects,
-
Immediately notify ESA and in that regard provide information on the circumstances of the accident, the identity and amount of GMM is released, the emergency measures taken and their impact, as well as providing an analysis of the incident with recommendations to mitigate the effects and to avoid similar accidents in the future.
Chap. 6. Duty of disclosure, procedures etc.
§ 20. Duty of disclosure User is obliged to inform the approval and supervisory authorities of new information relevant to business and approval of it. Responsible for laboratory / facility is obliged to inform on matters relating to security and control of laboratory / facility. New information includes both matters that were not previously known and relationships come after notification / approval.
§ 21. Reporting authorities shall help may submit consolidated report to the Authority every three years about the experiences with the regulations for the contained use of genetically modified microorganisms.
The authorities shall at the end of each year send ESA a synoptic report on the contained use of Class 3 and Class 4 Signed in that year according to § 11 letter b, including a description of the purpose of and the dangers of the clathrate use.
§ 22. Calculation of deadlines The calculation of time limits in § 7 and § 11 shall be the period where the authority is waiting for additional information which it has requested the applicant in accordance with § 7 and § 12, or making a public examination or hearings in accordance with § 7 and § 12 is excluded.
Chap. 7. Commencement
§ 23. Entry into force This regulation comes into force on 1 January 2002. From that date is repealed:
-
Regulation of 11 February 1994 no. 127 regarding safety, classification and record-keeping by laboratories and facilities for contained use.
-
Regulation of 11 February 1994 no. 126 to report or approval for contained use of GMOs.
Annex I A. Application for approval of laboratories and facilities for contained use of genetically modified micro-organisms in laboratory scale
I. General information
1. Name and address of laboratory / facility:
E-mail:
Tel .:
Fax:
2. Responsible for laboratory / facility, including control and safety:
Name:
Qualifications / education:
E-mail:
Tel .:
Fax:
II. Information on business
3. Committees / selection responsible for biological safety:
4. Genetically modified microorganisms to be used:
5. Description of type of operations performed, including Mission:
III. Information on plant safety and containment, waste
Selvangivelse
6. The security measures are in accordance with Annex V:
Date:
The competent person's signature:
7. Description of containment measures:
Minimum containment level for laboratory scale ol seen in table in Annex C.
In special cases it may be necessary to combine these measures with measures for large-scale production of table in Annex D.
Containment Level 1
Name / room number:
Minimum Requirements:
[]
Surfaces (work surface) must withstand water, acids, alkalis, solvents, disinfectants, dekontamineringsagenser, and be easy to clean
[]
Autoclave instead
[]
The users should use appropriate protective clothing (overalls)
[]
Inactivation of GMMs in contaminated material and waste
Containment measures beyond this (depending on activity)
[]
Vector Control to detect rodents and insects
[]
Observation window or similar
Date:
The competent person's signature:
Containment Level 2
Name / room number:
Minimum Requirements:
[]
Surfaces (work surface) must withstand water, acids, alkalis, solvents, disinfectants, dekontamineringsagenser, and be easy to clean
[]
Autoclave for building
[]
access
[]
Signs with biohazard label on the door
[]
Measures to control dissemination of aerosols to a minimum
[]
The users should use appropriate protective clothing
[]
Vector Control to detect rodents and insects
[]
Inactivation of GMMs in contaminated material and waste
Containment measures beyond this (depending on activity)
[]
Microbiological safety enclosure
[]
gloves
[]
Observation window or similar
[]
Requirement for suitable footwear
Date:
The competent person's signature:
Containment Level 3
Name / room number:
Minimum Requirements:
[]
Separately laboratory
[]
Entrance to the laboratory through vestibule, ev. via airlock
[]
Laboratory must be airtight for fumigation
[]
Surfaces (work surfaces and floors) to withstand water, acids, alkalis, solvents, disinfectants, dekontamineringsagenser, and be easy to clean
[]
Microbiological safety enclosure
[]
Autoclave in laboratory unit (affiliated laboratory / facility), or alternatively validated methods for the safe transfer of material into an autoclave outside the laboratory device, specifically:
[]
access
[]
Signs with biohazard label on the door
[]
Measures to prevent the spread of aerosols
[]
Users should use appropriate protective clothing and footwear perform shift before getting into and out of the area
[]
gloves
[]
Vector Control to detect rodents and insects
[]
Observation window or similar
[]
Inactivation of GMMs in contaminated material and waste
Containment measures beyond this (depending on activity)
[]
Suppress relative to the pressure in the immediate surroundings
[]
The laboratory air extraction should be HEPA-filtered
[]
shower
[]
Inactivation of GMMs in effluent from hand wash or drain (drain) and showers and similar wastewater
[]
The laboratory must have own equipment
[]
Requirement for suitable footwear
[]
The laboratory shall have an emergency
[]
Communication Options from the workroom
Date:
The competent person's signature
Containment Level 4
Name / room number:
Minimum Requirements:
[]
Separately laboratory
[]
Laboratory should be airtight for fumigation
[]
Surfaces (work surfaces, floors, ceilings and walls) must withstand water, acids, alkalis, solvents, disinfectants, dekontamineringsagenser, and be easy to clean
[]
Entry to lab via airlock
[]
Suppress relative to the pressure in the immediate surroundings
[]
The laboratory air extraction and intake air must be HEPA-filtered
[]
Additional requirements for the treatment of air expelled unless virus captured by the HEPA filter
[]
Microbiological safety enclosure
[]
Autoclave (consistently) in laboratory device
[]
access
[]
Signs with biohazard label on the door
[]
Measures to prevent the spread of aerosols
[]
shower
[]
Complete clothing and footwear change prior to going in and out of the area
[]
gloves
[]
Vector Control to detect rodents and insects
[]
Inactivation of GMMs in effluent from hand wash or drain (drain) and showers and similar wastewater
[]
The laboratory must have own equipment
[]
Observation window or similar
[]
The laboratory shall have an emergency
[]
Requests for communication possibilities from workroom
[]
Inactivation of GMMs in contaminated material and waste
Date:
The competent person's signature:
8. Disposal
GMM should be inactivated before disposal. Specify types of waste, storage, transport, procedures for handling waste, methods of inactivation and destination of the waste.
Date:
The competent person's signature:
Attachment:
[]
A copy of the consent of the Labour Inspectorate for the construction of buildings, etc. according to the Working Environment Act § 19
Annex I B. Applications for approval of laboratories and facilities for contained use of genetically modified micro-organisms for large scale production
I. General information
1. Name and address of laboratory / facility:
E-mail:
Tel .:
Fax:
2. Responsible for laboratory / facility, including control and safety:
Name:
Qualifications / education:
E-mail:
Tel .:
Fax:
II. Information on business
3. Information on committees / selection Biosafety:
4. Genetically modified microorganisms that are to be produced:
III. Information on plant safety and containment, waste
5. [] The security measures are in accordance with Annex V
Minimum containment level for large-scale trials and production of GMM shown in the table in Annex D. In some special cases it may be necessary to apply a combination of measures from the table in Annex IV and table Annex D.
Whatever concerns the requirement that all waste and emissions should be inactivated by recognized methods before final disposal, with respect to GMM and any antibiotic resistance genes.
6. Containment levels is sought:
7. Description of the facility
A)
Give a description of the facility (location, building conditions and location of production Equipment). Plan shall be attached.
B)
Give a description of the facility's interior, engineering, production process, the type of operation including upstream and downstream equipment, and culture volume.
C)
Give a description of the containment measures, based on the minimum requirements specified in Annex I D.
8. Information about waste
A)
Enter types and quantity of waste from the production process, including intermediate, bi- and waste products and the presence of GMM in these.
B)
Construction for storage and handling of production waste, including volume and capacity, methods of inactivation and validation of the method for inactivation.
C)
Procedures for handling, storage and inactivation of other waste and spillage.
D)
Method for destruction of antibiotic resistance genes before release to the environment.
9. Description of quality assurance system to ensure the health and environmental
10. Contingency plans accidentally
Date:
The competent person's signature:
Attachment:
[]
A copy of the consent of the Labour Inspectorate for the construction of buildings, etc. according to the Working Environment Act § 19
Annex I C. Confinement measures and other protective measures for laboratory activities
Specifications
Containment Levels
1
2
3
4
1
Laboratory: insulation1
Not required Not required
Required Required
2
Laboratory: airtight for fumigation
Not required Not required
Required Required
equipment
Specifications
Containment Levels
1
2
3
4
3
Surfaces must withstand water, acids, alkalis, solvents, disinfectants, dekontamineringsagenser, and be easy to clean
Required (work surface)
Required (work surface)
Required (work surfaces, floors )
Required (work surfaces, floors, ceilings, walls)
4
Entry to the laboratory through vestibule / luftsluse2
Not required Not required
Required through vestibule, ev. airlock
Required airlock
5 Suppress relative to the pressure in the immediate surroundings
Not required Not required
Required except for3
Required
6
laboratory air extraction and intake air must be HEPA-filtered Not required
Not required Required (HEPA) 4 - air extraction except for3
Required (HEPA) 5 - intake air and air extraction
7
Microbiological safety enclosure
Not required
Optional
Required
Required
8
Autoclave
On site
In building
Throughout laboratorieområdet6
Laboratory = with review
Work System
Specifications
Containment Levels
1
2
3
4
9
Limited access
Not required
Required
Required
Required
10
Biological danger mark on door
Not required
Required
Required
Required
11
Special measures to control the spread of aerosol
Not required
Required, minimized
Required prevented
Required prevented
13
Shower
Not required Not required
Optional Required
14
Protective
Designated clothing
Suitable protective clothing (optional footwear)
Suitable protective clothing
complete clothing and footwear change before moving in and out of the area
15
Gloves
Not required
Optional
Required
Required
18
Efficient vector control (eg. To detect rodents and insects)
Optional
Required
Required
Required
waste
Specifications
Containment Levels
1
2
3
4
19
Inactivation of GMMs in effluent from hand washing or drains and showers and similar wastewater
Not required Not required
Optional Required
20
Inactivation of GMMs in contaminated material and waste
Required
Required
Required
Required
Other measures
Specifications
Containment Levels
1
2
3
4
21
laboratory must have their own equipment
Not required Not required
Optional Required
22
There must be an observation window or similar device so that people in the room can be seen
Optional
Optional
Required
Required
23
There must be communication effort workroom
Not required
Optional
Optional
Required, handsfree phone / calling plan
24
Working premises must have an emergency power
Not required Not required
Optional Required
Annex I D. Confinement measures and other control measures for production / large scale business
General
Specifications
Containment Levels
1
2
3
4
1
Viable microorganisms entrapped in a system which separates the process from the environment (closed system)
Required Required Required
Required
2
Control of gas emissions from the closed system
Required, minimize dissemination most
Required, minimize dissemination most
Required, prevent the spread
Required, prevent the spread
3
controls aerosol sampling, supplying material to a closed system or transfer of material to another closed system Optional
Required, minimize dissemination most
Required, prevent dissemination | || Required, prevent the spread
4
Inactivation of liquid media in bulk before removal from the closed system
Required, by validated methods
Required, by validated methods
Required, by validated methods
Required, by validated methods
5 Seals should be designed so that emissions be minimized or prevented
Reduce spread most
Reduce spread most
Preventing the spread
Preventing the spread
6
The controlled zone should be designed in such a way that the overflow water from the enclosed system can capture the entire contents therefrom
Required
Required
Required
Required
7
The controlled zone shall be sealable to allow outgassing
Not required
Optional Optional
Required
equipment
Specifications
Containment Levels
1
2
3
4
8
Entrance through vestibule / airlock
Not required Not required
Required through vestibule, ev. airlock
Required airlock
9
Surfaces must withstand water, acids, alkalis, solvents, disinfectants, dekontamineringsagenser, and be easy to clean
Required (or work surface)
Required (or work surface)
Required (or work surfaces, floors)
Required (work surfaces, floors, ceilings, walls)
10
Special measures for proper ventilation of the controlled zone to reduce air contamination most
Optional
Optional
Optional
Required
11
The controlled zone should have negative pressure relative to the immediate surroundings
Not required Not required
Optional
Required
12
The controlled zone air extraction and intake air must be HEPA-filtered Not required
Not required Required (air extraction, optional for incoming air)
Required (intake air and air extraction) || |
Work System
Specifications
Containment Levels
1
2
3
4
13
Closed systems should be located within a controlled zone
Not required
Optional
Required
Required
14
Only designated personnel shall have access
Not required
Required
Required
Required
15
Biological hazard notice shall be posted
Not required
Required
Required
Required
17
Personnel should shower before leaving the controlled zone
Not required Not required
Optional Required
18
Staff should wear protective clothing
Required suitable workwear
Required suitable work clothing, or clothing (optional footwear)
Required suitable work clothes, suitable clothing and footwear shift before moving in and out of the area | || Required suitable protective clothing, complete clothing and footwear change before moving in and out of the area
waste
Specifications
Containment Levels
1
2
3
4
19
Inactivation of GMMs in effluent from sinks and showers or similar wastewater
Not required Not required
Optional Required
20
Inactivation of GMMs in contaminated material and waste, also in process pill water before final discharge
Required, by validated methods
Required, by validated methods
Required, by validated methods
Required with validated methods
Other measures
Specifications
Containment Levels
1
2
3
4
21
There must be communication effort workroom
Not required
Required
Required
Required handsfree phone / calling plan
22
Working premises must have an emergency power
Not required Not required
Optional Required
23
staff should have access to decontamination and sanitary
Not required
Required
Required
Required
Annex I E. Applications for approval of laboratories and facilities for contained use of genetically modified microorganisms in combination with animal
I. General information
1. Name and address of laboratory / facility:
E-mail:
Tel .:
Fax:
2. Responsible for laboratory / facility, including control and safety:
Name:
Qualifications / education:
E-mail:
Tel .:
Fax:
II. Information on business
3. Committees / selection responsible for biological safety:
4. Genetically modified microorganisms to be used:
5. Description of type of operations performed, including Mission:
6. Type of animal to be worked with:
[]
Vertebrates, specify:
[]
Invertebrates, specify:
[]
Aquatic animals, specify:
III. Information on plant safety and containment measures and waste
Selvangivelse
7. The security measures are in accordance with Annex IF
Date:
The competent person's signature:
8. Disposal
GMOs should be inactivated before disposal with validated methods such as autoclaving or incineration. Specify types of waste, storage, transportation, 1 procedures for handling waste, methods of inactivation and Setting Destination.
9. Description of containment measures:
Requirements for containment measures for laboratories and facilities for contained use of genetically modified microorganisms in combination use with animals is determined by which group the animal fit under and risk activities generate. The requirements stated in the table in Annex F. requirements should be met to the extent that they are relevant to business. For each room is sought must be ticked for the measures applied. For operations with invertebrates and aquatic animals must be ticked for both the general measures employed, and the specific measures applied.
For the approval of laboratories and facilities to infection experiments with aquatic animals required enclosed copy of the approval of facilities for disinfection of wastewater under the Act of 13 June 1997 no. 54 on measures to combat diseases in fish and other aquatic animals.
Name / room number:
Containment levels is sought:
Date:
The competent person's signature:
Construction / furnishings
[]
Separately expensive device with access
[]
Animal rooms separated from adjoining rooms with doors locked outside working
[]
Shutoff Mechanisms enabling gassing
[]
Floor and / or walls easily washable
[]
Benches and floor resistant to water, acids, alkalis, solvents and disinfectants, dekontamieringsagenser and is easy to clean
[]
Walls resistant to water, acids, alkalis, solvents and disinfectants, dekontamieringsagenser and is easy to clean
[]
Hand washing is available
[]
Hand washing can be operated without the use of hands and there are hand disinfectant
[]
Entry to the unit via airlock
[]
Airlock with sink and shower
[]
Airlock with negative pressure dressing and showering
[]
The device has a negative pressure relative to the pressure in the immediate surroundings
[]
The air recirculates not to other parts of the building
[]
The device is designed to prevent reverse flow and overpressure
[]
Separate channel system for phasing in and air extraction. Blowing through the HEPA filter
[]
Separate ventilation systems for maintaining negative pressure connected alarm systems, intake air through one HEPA filter, air extraction via two HEPA filters in series
[]
Other measures for the treatment of air extraction if virus is not captured by the HEPA filter. Refine:
[]
The unit has installed an alarm to detect fire, failure of the ventilation and heating and intruders
[]
Autoclave is available
[]
On facility
[]
In building
[]
In device
[]
Duplex autoclave available at the entrance to the zone and at the end of the device
[]
Alternatively, validated methods for the safe transfer of material into an autoclave outside the laboratory device, specifically:
[]
The animals are reared
[]
In appropriate cages, fences and the like
[]
In biological sikkerhetsisolator / safety cabinet
[]
In biological sikkerhetsisolator with ventilation through HEPA filter in the environment or in separate ventilation units with air extraction behind animals
Disposal
[]
GMM and contaminated waste from animals (including litter, food, etc.) must be removed so that dust and aerosols are minimized and inactivated
[]
Wastewater from sinks, showers and autoclave collected and inactivated before release
Work and equipment
[]
Only authorized personnel have access
[]
Only experimental animals are allowed in the unit
[]
Suitable protective clothing used
[]
Complete clothing and footwear change before the entrance and exit
[]
Work on safety cabinet or isolator (and, if class)
[]
The cages are waterproof, easily washable and dekontaminerbare
[]
Observation window or similar
[]
Signs with biohazard label on the door
[]
Measures to control dissemination of aerosols to a minimum
[]
Wearing gloves
[]
The laboratory has its own equipment
Containment measures
[]
Rodent Barrier front door / even closure mechanism for the door
[]
Joints between the door, door frame and walls are sealed / tight
[]
Joints between walls, floors and ceilings are covered charges. rounded for easier cleaning
[]
Drains and other openings in floors and walls are protected against escapes / accidental discharge of rodents and insects
[]
Vector control to prevent the ingress of rodents and insects from outside
10 Specific containment measures for invertebrates
[]
Separate rooms for infected and not infected invertebrates available
[]
The unit has the ability to seal gassing
[]
Measures to reduce invertebrate activity and the possibility of escape for example. cooling
[]
The entrance to the unit goes through a gate with arthropodetette web front door and insektsfangere
[]
Ventilation ducts for outgoing air and windows are covered with arthropodetett network
[]
All sinks and channels / drains have the opportunity to collect / siphon
[]
Experiments with flightless and crawling arthropods carried out on white barrel easier to detect escapes
[]
Flying insects enclosed in boxes / cages with double mesh, ventilation filtered
[]
Working with arthropods carried out in isolates or safety cabinet
Please provide any additional containment measures are used:
Specific containment measures for aquatic animals
[]
Tanks must be covered with a lid or netting to prevent escapes
[]
Aquatic animals (including: eggs, fry, etc.) must be prevented from being discharged through the gully
[]
The wastewater will be inactivated to prevent the spread of genetically modified microorganisms, alarm systems shall be installed to monitor the inactivation process occurs satisfactory
[]
The unit shall be designed so that the discharge (flood, leakage, etc.) from the tank, the genetically modified microorganisms inactivated before it runs out of the drainage system linked to the plant
Please provide any additional containment measures are used:
Date:
The competent person's signature:
Attachment:
[]
A copy of the consent of the Labour Inspectorate for the construction of buildings, etc. according to the Working Environment Act § 19
Annex I F. Containment Measures activity with genetically modified microorganisms in combination use with animals
Construction / furnishings
1
2
3
4
Isolation of animal unit
No
yes
Yes, separated by airlock from other animal rooms and laboratories
Yes, associated laboratory class 4 ev. isolated unit / building, entrance via airlock
Animal rooms separated from adjoining rooms with doors locked outside working
yes
yes
yes
Yes, door with viewing window
Shutoff Mechanisms enabling gassing
No
JA1
JA1
Yes, possibility of sealing the doors
Floor and / or walls must be easily cleanable
yes
yes
yes
yes
Surfaces must withstand water, acids, alkalis, solvents and disinfectants, dekontamieringsagenser and be easy to clean
benches and floors
benches and floors
benches, floors and walls
benches, floors, ceilings and walls
Handwash Available
Wash operable without the use of hands, hand disinfectant
Wash operable without the use of hands, hand disinfectant
Wash operable without the use of hands, hand disinfectant
Entry to the unit via airlock
No
No
Airlock with hand basin and dusj1
Airlock negative pressure for dressing and showering
Unit shall have a pressure lower than atmospheric pressure
No
Yes, the air should not be recirculated to other parts of bygningen1
Yes, designed to prevent reverse flow and overpressure
Yes, designed to prevent reverse flow and overpressure
Ventilation - Safety air expelled from the unit shall be filtered
Separate channel system, air extraction via HEPA filter, 1 filter should be tested and replaced safely
Separate ventilation system for maintaining negative pressure connected alarm systems, intake air through one HEPA filter, air extraction via 2 HEPA filter in Serie2
Unit shall have installed alarm to detect fire, failure of the ventilation and heating and intruders
yes
yes
yes
yes
Autoclave On facility
In building
In device
Duplex autoclave should be available at the entrance to the zone and at the end of the device
Stabling of animals
Suitable cage, aviary and the like
Biological sikkerhetsisolator / enclosure
Isolator with ventilation through HEPA filter to the environment or separate ventilation units with air extraction behind animals
Isolator with ventilation through HEPA felts to the environment or separate ventilation units with air extraction behind animals
Disposal
1
2
3
4
Waste from animals must be removed so that dust and aerosols minimized
yes
yes
yes
yes
Waste water from sinks, showers and autoclave should be collected and inactivated before release
No
No
No
yes
Incinerator on site to inactivation of cadavers and solid
Valgfritt3
Valgfritt3
Valgfritt3
Yes
Work and equipment
1
2
3
4
Only authorized personnel have access
yes
yes
yes
yes
Only experimental animals are allowed in the unit
yes
yes
yes
yes
Security Cabinet
No
Working with the possibility of developing aerosoler1
Yes
All work safety cabinet class III or insulator
Biological hazard markings on the doors
No
yes
yes
yes
Measures to prevent the spread of aerosols
No
Yes, minimize
Yes, prevent
Yes, prevent
Protective clothing Suitable protective clothing Suitable protective clothing
Suitable protective clothing Complete dressing
Gloves
No
No
yes
yes
Laboratory must have own equipment
No
No
yes
yes
Efficient vector control against ingress of rodents / insects
No
yes
yes
yes
Cages should be waterproof, easily washable and dekontaminerbar
yes
yes
yes
yes
Containment measures
Rodent Barrier front door / selvlukningsmekanisme the door
yes
yes
yes
yes
Joints between the door, door frame and walls should be sealed / tight
yes
yes
yes
yes
Joints between walls, floors and ceilings shall be covered if necessary. rounded for easier cleaning
yes
yes
yes
yes
Drains and other openings in floors and walls should be secured to prevent escape / accidental discharge of rodents and insects
yes
yes
yes
yes
Specific requirements for invertebrates
Containment Level 1
-
Separate rooms for infected and not infected invertebrates should be available
-
Unit shall have the opportunity to seal gassing,
-
Measures to reduce invertebrate activity and the possibility of escape for example. cooling
-
Entrance to the device to go through a gate with arthropodetette web front door and insektsfangere,
-
Ventilation ducts for outgoing air and windows should be covered with arthropodetett networks,
-
All sinks and channels / drains should have the opportunity to collect / water trap
-
Trials flightless and crawling arthropods be performed on white barrel easier to detect escapes.
Containment Level 2, 3 and 4
-
Working with arthropods be performed in insulators or safety cabinet,
-
Flying insects shall be enclosed in boxes / cages with double mesh, ventilation should be filtered.
Specific requirements for aquatic animals
All containment levels
-
Aquatic animals contaminated / infected with GMM (including: eggs, fry, etc.) must be prevented from penetrating the water supply system, prevented from being discharged through the gully, and prevented from being discharged in sewerage system using two barriers,
-
Tanks should be covered with a lid or netting to prevent escapes,
-
Wastewater must be inactivated to prevent the spread of genetically modified microorganisms, alarm systems shall be installed to monitor the inactivation process occurs satisfactory
-
Device shall be so constructed that the discharge (flood, leakage, etc.) from the tank, the genetically modified microorganisms inactivated before it assume drains affiliated facility.
Annex II A. Message / application for approval of contained use of genetically modified microorganisms
Message []
Application pursuant to § 11 a []
Application pursuant to § 11 letter b []
Laboratory Scale []
Large scale []
1.1 General information
1. Names and qualifications of the responsible (s) person (s) for the contained use, including control and safety:
2. Institution Name:
3. Address:
Tel .:
Fax:
E-mail:
4. The laboratory / facility's name and address:
Dispatched the new application for laboratory equipment?
Yes []
No []
If not, a copy of earlier approval of laboratories and facilities attached
5. Name of the person responsible for the laboratory / facility:
6. The laboratory / facility's containment level:
Description of business:
7. Description of the modification, including:
In.
Description of the recipient, donor and / or parental organism (s) and host / vector system used:
Ii.
The inserted genetic material originated, planned function and genetic stability:
Iii.
The modified organism identity and characteristics:
8. How large culture volumes to be used:
9. Containment levels needed for business, as a result of the pre-assessment of risk undertaken by Annex III, ref. § 5 and § 6
10.
The purpose of the contained use, including the expected results and planned duration:
11.
Specific containment measures and other precautions against accidental release of genetically modified organisms, including information on waste management (waste types, volume, method of inactivation, final form and destination), as a result of the pre-assessment of risk undertaken by Annex III, ref. § 5 and 6.
12.
By large-scale operations, validation of inactivation of GMM, and method and validation for inactivation of any antibiotic resistance genes, including a method for detection of these waste products, cf. § 15.
13.
Description of plans for prevention of accidents, contingency plans / measures Accidental release of genetically modified microorganisms, by businesses in containment level 3 and 4, and by all businesses large
-
Special hazards due to construction site
-
Applied preventive measures, for example. safety equipment, alarm systems and containment methods,
-
Procedures and plans for control of the containment measures are still effective,
-
A description of information provided to workers.
Date:
Signature:
Attachment:
Copies of previous approval of laboratories and facilities []
New applications for approval of laboratories and facilities []
By business class 1 and 2, summaries of the pre-assessment of the activities under Annex III []
By business class 3 and 4, a copy of the entire pre-assessment of the activities under Annex III []
Social and ethical considerations in accordance with § 11 a ref. Also § 13 of Regulation []
A copy of the message to the Directorate of Labour Inspection of the use of biological agents in the workplace in accordance with § 16 of the Regulation on the protection of workers against hazards when working with biological factors []
Annex II B. Message / application for approval of contained use of animals in combination with genetically modified microorganisms
Message []
Application []
General information
1. Names and qualifications of the person responsible for the contained use:
2. Institution Name:
3. Address:
Tel .:
Fax:
E-mail:
4. The laboratory / facility's name and address:
Dispatched the new application for laboratory equipment?
Yes []
No []
If no copy of the earlier approval of laboratories and facilities attached.
5. Name of the person responsible for the laboratory / facility:
6. The laboratory / facility's containment level:
Description of business / project:
7. Vitenskapelig- and common name of the genetically modified / unmodified organisms which are included in use:
8. Containment levels needed for business, as a result of the pre-assessment of the risks undertaken under § 5, ref. Paragraph 14 below
9. Estimated amount / number of animals to be used:
10. Description of the modification, including:
In.
The inserted genetic material origin (donor), planned function and genetic stability:
Ii.
Host / vector system:
Iii.
The modified organism feature and function:
11. The purpose of the contained use, including the expected results and planned duration:
12. Special measures against accidental release / escape of genetically modified organisms, including waste management (waste types, volume, method for inactivation of GMM, also in animals, final form and destination), as a result of the pre-assessment undertaken in accordance with § 5, ref. Paragraph 14 below:
13. Description of plans for prevention of accidents, contingency plans / measures Accidental release of genetically modified microorganisms, by businesses in containment level 3 and 4:
-
Special hazards due to construction site
-
Applied preventive measures, for example. safety equipment, alarm systems and containment methods,
-
Procedures and plans for control of the containment measures are still effective,
-
A description of information provided to workers.
14. Preliminary assessment by combination use
By prior assessment of business pursuant to § 5, the following items are specified separately in the summary / copy of the pre-assessment:
-
Hazardous properties of the genetically modified micro-organism properties
-
Possibility of separation of genetically modified micro-organisms from animals
-
About material from animals may involve a risk of spreading genetically modified microorganisms
-
Possibility of horizontal gene transfer, for example. via viral vectors and arthropods
-
Risk to humans, animals and plants by the spread of genetically modified microorganisms accidental release.
Date:
Signature:
Attachment:
Copies of previous approval of laboratories and facilities []
New applications for approval of laboratories and facilities []
By business class 1 and 2, summaries of the pre-assessment of the activities under § 5, ref. Paragraph 14 above []
By business class 3 and 4, a copy of the entire pre-assessment of the activities under § 5, ref. Paragraph 14 above []
Social and ethical considerations under § 11a cf. Also § 13 of Regulation []
A copy of the message to the Directorate of Labour Inspection of the use of biological agents in the workplace in accordance with § 16 of the Regulation on the protection of workers against hazards when working with biological factors []
Appendix III. Principles to be followed for the assessment referred to in § 5
This appendix provides a general description of the elements that must be taken into account and the procedure to be followed in the implementation of the assessment referred to in § 5. The Annex, in particular as regards Part B, complemented with the guidance notes in Annex IV .
A. Rating Elements
1.
The following items should be considered as potentially harmful effects:
-
Disease in humans, including allergenic or toxic effects,
-
Disease or other negative effects on animals, plants and other living organisms,
-
Harmful effects due to the impossibility to treat a disease or provide effective prophylaxis,
-
Harmful effects due to establishment or dissemination in the environment,
-
Harmful effects due to natural transfer of inserted genetic material to other organisms.
2.
Assessment referred to in § 5 should be based on the following elements:
A)
identification of potentially harmful effects, especially those associated with:
I)
recipient microorganism
Ii)
the genetic material inserted (originating from the donor organism)
Iii)
vector
Iv)
donor microorganism (as long as the donor micro-organism used in business)
V)
the GMM that emerges,
B)
characteristics of the business,
C)
extent of the potential harmful effects,
D)
likelihood that the potential harmful effects occur.
B. Procedure
3.
The first step in the assessment process should be to identify the recipient and any donor microorganism damaging properties and harmful properties associated with the vector or inserted material, including any alteration in the recipient's existing properties.
4.
In general, it just GMM with the following characteristics will be considered appropriate to include in class 1 as defined in § 6:
I)
recipient or parental micro-organism is not likely to cause disease in humans, animals or plants, 1
Ii)
vector and the insert is of such a nature that they do not provide GMM a phenotype likely to cause disease in humans, animals or plants, 1 or likely to have harmful effects on the environment,
Iii)
GMM will probably not cause disease in humans, animals or plants1 and is not likely to have harmful effects on the environment.
5.
To obtain information necessary for implementing this process, the user can first take into account relevant regulations as EU Directive 90/679 / EEC. International or national classification schemes (eg. WHO, NIH, etc.) And the audit they have undergone as a result of new scientific knowledge and technical progress may also be considered.
These arrangements apply to natural microorganisms, and as such are usually based on microorganisms' ability to cause disease in humans, animals or plants and on the scope and transferability of the disease likely to be caused. Directive 90/679 / EEC classifies micro-organisms, as biological agents, into four classes of risk on the basis of potential effects on a healthy, adult human. These classes of risk can be used as a guide by the division of the activities contained use in the four classes of risk referred to in § 6. The user may also take into consideration classification schemes for plant and animal pathogenic agents. The above classification schemes give only a provisional indication of the risk class of the activity and the corresponding set of containment and control measures.
6.
The process of mapping the risk carried out in accordance with paragraph. 3-5, should lead to identification of the risk level associated with the GMM.
7.
Containment measures and other protective measures should then be chosen from the level of risk associated with the GMM, and having regard to:
I)
characteristics of the environment likely to be exposed (eg. About it in the environment that could be exposed, are known biota which can be adversely affected by the microorganisms used in operations contained use) ,
Ii)
characteristics of the business (eg. Its scope, nature)
Iii)
any nonstandard operation (eg. Inoculation of GMM in animals, equipment that probably can emit aerosols).
Depending on the consideration of the points in - iii for a particular business, the level of risk associated with the GMM surveyed by paragraph 6, increase, decrease or remain unchanged.
8.
When the analysis is performed as described above, this will eventually lead to the business placed in one of the classes described in § 6
9.
The final classification of the contained use should be confirmed by re-examination of the completed assessment referred to in § 5
Annex IV. Guiding notes on risk assessment referred to in Annex III
1. Introduction
The elements that should be emphasized in the risk assessment under paragraph. 1 and 2 in Annex III, means that it must be considered potentially harmful effects on human and animal health and the environment. Potentially harmful effects are defined as effects that may lead to disease, the prophylaxis or treatment ineffective, promote the creation and / or spread in the environment that gives harmful effects on organisms or natural populations, or adverse effects due to gene transfer to other organisms. In considering the risk of these potentially harmful effects are considered for each activity and classified while taking into account the nature and scope, to determine the type of containment measures required to end. The risk arising from contained use of genetically modified microorganisms (GMM) and the construction of such organisms is determined by the severity of the potential harmful effects on human health and the environment, and the likelihood that those effects occurring. The risk assessment shall take account of human or environmental exposure for GMM is due to the operation of, or possible unintended release from, a contained use facility. The classification level determined by the risk assessment defines the containment requirements for the activities involving GMMs.
2. Risk
A full risk assessment consists of the following steps:
2.1.
Step 1
Identify potential harmful properties (hazard) of the GMM to an initial class of the (group 1-4) on the basis of the severity of the potential harmful effects, and assessment of the likelihood that there will be adverse effects from exposure (both human and environmental) taking into account the nature and scope, with containment measures appropriate to the initial classification.
2.2.
Step 2
Determination of final classification and containment measures required for the activity. By assessing step 1 again should it be confirmed that the final classification and final containment measures are appropriate.
3.
Step 1
3.1.
Identification of harmful properties (hazard) of the GMM
Risk assessment process requires the identification of any potentially harmful properties of the GMM as a result of the genetic modification or any alteration of the recipient organisms' existing properties. GMM potentially harmful properties must be determined by examining the recipient organism, the donor organism, the inserted genetic material characteristics and location and any vectors. It is important to take into consideration that genetic modification of a microorganism can affect its ability to harm public health and the environment. Genetic modification may lead to the ability to damage decreases, unchanged or increased.
3.2
Aspects that should be considered where they are relevant:
3.2.1.
Recipient organism
-
Species of pathogenic ability and virulence, infectivity, sensitizing ability, toxicity and vectors of disease transmission,
-
Species of naturally occurring vectors and random bundled agents that could mobilize the inserted genetic material, and frequency of mobilization,
-
Nature and stability of any passivating mutations
-
Any prior genetic modifications,
-
Host range (if relevant)
-
Any significant physiological traits which may be altered in the final GMM and if relevant, Diss stability
-
Habitat and geographic distribution,
-
Significant involvement in environmental processes (eg. Nitrogen bond or pH adjustment)
-
Interaction with and impact on other organisms in the environment (including likely competitive, pathogenic or symbiotic properties)
-
Capable of forming survival structures (eg. Spores or sclerotia).
3.2.2.
Donor organism (by fusion experiments or hagl- (eng .: shotgun) experiments where the insert is not well characterized)
-
Species of pathogenic ability and virulence, infectivity, toxicity and vectors of disease transmission,
-
Species of naturally occurring vectors
-
Sequence
-
Frequency of mobilization and specificity,
-
Occurrence of genes conferring resistance to antibiotics such. antibiotics,
-
Host range,
-
Other relevant physiological traits.
3.2.3.
The insert (eng .: the insert)
-
The insert specific identity and function (genes)
-
Expression level of the inserted genetic material,
-
Genetic material origin, donor organism (s) identity and characteristics where relevant,
-
Account of previous genetic modification, where applicable,
-
The inserted genetic material placement (the possibility of activation / inactivation of host genes as a result of insertion).
3.2.4.
The vector
-
Vector species and source
-
Structure and amount of vector and / or donor nucleic acid remaining in the modified microorganism final structure,
-
If the prisoner vector is present in the final GMM, frequency of mobilization and / or ability to transfer genetic material.
3.2.5.
The final GMM
3.2.5.1.
Health assessments
-
Expected toxic or allergenic effects of the GMM and / or its metabolic products,
-
Comparison of the modified micro-organism and the recipient or (if appropriate) parental organism pathogenic capability
-
Expected capacity for colonization,
-
If the microorganism is pathogenic for immunocompetent humans:
-
Induced diseases and transmission mechanisms including invasiveness and virulence,
-
Infective dose,
-
Possible change of a transmission path or tissue specificity,
-
Possibility of survival outside of human host,
-
Biological stability,
-
Antibiotic resistance pattern,
-
Allergenic capability
-
Genotoxicity,
-
Access to appropriate therapies and prophylactic measures.
3.2.5.2.
Environmental assessments
-
Ecosystems where microorganism unintentionally released from the contained use,
-
The modified micro-organism expected survivability, multiplication and dissemination in the identified ecosystems,
-
Anticipated result of interaction between the modified micro-organism and organisms or microorganisms that may be exposed accidental release into the environment,
-
Known or predicted effects on plants and animals, for example. pathogenic ability, toxicity, sensitizing ability, ability to act as vectors for a pathogenic organism, altered antibiotic resistance patterns, altered tropism or host specificity, colonization,
-
Known or predicted involvement in biogeochemical processes.
3.3.
Preliminary classification of GMM
By no. 5.3 of Annex III indicate that the first step in the risk assessment process for a GMM is to identify the potential harmful effects of the GMM, so it can determine an initial classification of it. This is achieved by identifying the hazards associated with the recipient, donor organism, vector and insert where appropriate. This process can be taken into account the general characteristics for class 1 set out in paragraph. 4 of Annex III and appropriate up to date national and international classification schemes. Similarly, containment and other protective measures serves as a reference set of measures to determine whether it required more stringent containment and control measures to control identified harmful effects.
Risk of damage caused by harmful properties of the GMM, the consideration of the severity of the harm and any biological properties (eg. Passivating mutations) which limit the likelihood of it occurring damage. The severity of the harmful effects is performed independently of the probability that the damage actually occurs. The severity of any possible harm is determined by considering the consequences of it, and the probability that damage will occur in a given case. For a pathogenic GMM shall example. estimate how serious the disease would be assuming that the susceptible species was infected. The initial classification of GMM includes consideration of severity. Classification Schemes such. Directive 90/679 / EEC, taking into account the severity. Many of these schemes are based only on either human health or environmental considerations. It is important to ensure that an overall assessment of the severity of GMM harmful effects on human health and the environment.
3.4.
Assessment of possibility of harmful effects occurring
They (n) important factor (s) that affects the probability of a harmful event occurring is the level and nature of human or environmental exposure to a particular GMM. In most cases, the exposure of vital importance for the risk assessment, since it will often determine whether a harmful effect could occur. The likelihood that humans or the environment is exposed to a GMM depends on the activities carried out (eg. The scope) and containment measures taken as a result of the initial classification referred to in paragraph. 5 and 6.
Under paragraph. 7 points ii and iii of Annex III shall take account of the nature at the final classification and selection of control measures. Consideration should be given to the nature and scope to assess the likelihood of human and environmental exposure, and this will also affect the choice of appropriate methods of risk management.
Characteristics of the operation that could affect the risk assessment and therefore should be taken into account as appropriate include the activities to be undertaken, work practices, scale and implemented containment measures.
The evaluation will take particular account of how waste and wastewater to be disposed of. Where appropriate, the necessary safety measures to protect human health and the environment.
3.4.1.
The nature of the planned activities
Risk level for a GMM and application of control measures to reduce that risk to an appropriate level will be influenced by the planned nature of the business, since these will affect human and environmental exposure and hence possibility of harm occurring.
Nature of the activities will also determine which table containing the most appropriate containment and control measures to be considered.
In practice, it is unlikely that a detailed risk assessment will be required for each individual procedure works on laboratory scale where the effect of standard procedures on exposure are well known, unless it is used a very dangerous organism. A more detailed assessment may be necessary in connection with procedures that are not routine or practices that may significantly affect the risk, for example. procedures which generate aerosols.
3.4.2.
Concentration and scope
Cultures with high concentrations may cause a risk of exposure to high concentrations of the GMM, particularly in connection with operations further into the process. Therefore, account must be taken of concentration on the probability that a harmful event occurring.
Size is another factor that must be considered in the risk assessment. The scope can be expressed as a single operation absolute volume or the frequent repetition of a process, because both can lead to increased likelihood of exposure if the containment and control measures failed and thus affect the possibility of a harmful event occurring.
Although a large scale does not necessarily mean high risk, increased scale may lead to greater likelihood of exposure both in terms of number of people and the amount of environmental exposure that might occur event of containment failure.
Scale will also influence which table contains the most appropriate containment and control measures.
3.4.3.
Growing conditions
In many contained use activities, the culture conditions are rigorously contained to protect the ongoing work, but the nature and design of the growth vessels or other culture equipment will also influence the level of risk to human health and the environment. Exposure to, and hence risk from a GMM can be reduced considerably by means of well-engineered and sealed fermentation vessels. It is important to investigate how reliable this equipment and the possibility that the equipment may fail if such a failure could lead to high levels of exposure to harmful GMMs. If such loss is reasonably foreseeable, it may need additional containment measures. Standard operating procedures of individuals undertaking work with cultured GMMs such. centrifugation or sonication will have a great impact on any containment measures effectiveness.
In combination with physical culture conditions that act as containment measures, both biological and chemical measures that are employed to protect the work can also contribute significantly to the containment measures required. Examples of biological containment could well be auxotrophic mutants that require specific growth factors to grow. Examples of chemical containment measures could be disinfectant solutions maintained in drainage systems.
. In paragraph 7 point ii Annex III states that the assessment of the likelihood of harmful effects occurring and their severity, shall take into consideration the characteristics of the environment likely to be exposed and the severity of its effects.
Several aspects are important when taking into account of the environment, for example. of environmental scope and nature and whether there are biota which can be damaged by the particular GMM in the area exposed.
The following factors should be taken into consideration when assessing how the characteristics of the receiving affect the possibility that the potentially harmful effect will be realized and hence the level of risk and selection of control measures.
3.4.3.1.
Environment likely to be exposed
The environment likely to be exposed, is limited in most cases to the workplace and the area immediately surrounding the facility, but depending on the specific characteristics of the contained use and the facility, it may be necessary to take account of the environment in further meaning. The extent of the environmental exposure may be influenced by the scope and nature, but it should also be given to all possible modes of transmission into the wider environment. These may include physical modes (such as local drains, watercourses, waste disposal, air movement and biological vectors (such infected animals and insects that moves)).
3.4.3.2.
Presence of susceptible species
The possibility of harm occurring will depend on whether there are susceptible species, including humans, animals and plants, in the environment that may be exposed.
3.4.3.3.
Can the environment contribute to the GMM survive?
The question of the extent to which the GMM can survive and persist in the environment is an important aspect in the risk assessment. The probability of harm occurring will be significantly reduced if a GMM can survive in the environment it will be able to gain access.
3.4.3.4.
Effects on the physical environment
In addition to direct harmful effects of a GMM, regard shall be had to indirect harmful effects from significantly altering the physico-chemical properties and / or ecological balance of environmental soil or water components.
4. Step 2
4.1.
Determination of final classification and containment measures
When all potentially harmful characteristics have been reviewed and the severity and the probability of their occurrence is determined, while taking into account the containment and control measures indicated by the initial classification of the recipient, the final classification and final containment measures for GMM determined. In assessing the final classification and containment measures should the initial classification reassessed to see if it was right out of the operations to be performed and the nature of the planned operations. A comparison of the initial classification and associated containment measures with the final class and the associated containment measures, can give rise to three results:
-
There are harmful effects that it has not been taken sufficiently into account by the initial classification, and the provisional containment considered under Procedure 1 is not adequate for these. It is therefore necessary with additional containment measures and possibly revision of the classification of operations,
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The initial classification was correct and the associated containment measures are sufficient to prevent damage to human health and the environment, or to restrict them to a minimum,
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The preliminary classification is higher than necessary for the operations in question, and therefore you should select a lower classification with its attendant containment measures.
4.2.
Confirmation that the final containment measures are adequate
When the final classification and final containment measures are in place, the level of exposure for humans and the environment are assessed again (step 1). In this way it is confirmed that the likelihood of harm occurring is so low that it is acceptable, on the basis of the nature and scale and the proposed containment measures. Once this is done the risk assessment is complete.
The regulations state that if the nature or scale changes significantly or new scientific or technical knowledge that the risk assessment is no longer appropriate, the risk assessment must in light of these changes. Any alteration in containment conditions as a result of the revision of the risk assessment must be applied forthwith to maintain adequate protection for human health and the environment.
Classification and the containment and control measures identified in the risk assessment as required to adequately contain the GMM-one in conjunction with the planned activity, causes the contained use classified in group 1-4. Containment and control measures for each group described in Annex IV of the Directive.
The administrative requirements are determined on the basis of the classification of the contained use of GMM.
If there is uncertainty regarding the final classification and final containment measures, should contact the competent authority.
Appendix V. General safety
For all activities involving GMMs the principles of good microbiological practice and the following principles for good safety and hygiene at work:
I)
ensure that the workplace and the environment are exposed to the GMM at such a low level as possible
Ii)
use engineering controls at the source and complement these measures with appropriate clothing and personal protective equipment if necessary,
Iii)
regularly try and maintain control measures and equipment appropriately,
Iv)
possibly verify the presence of viable organisms from activities outside the primary physical containment,
V)
give staff appropriate training,
Vi)
if necessary set up committees or subcommittees Biosafety
Vii)
if necessary design and implement locally practical regulations for the safety of personnel,
Viii)
set up biohazard brands where needed,
Ix)
ensure that staff have washing and decontamination,
X)
lead satisfactory records,
Xi)
prohibit eating, drinking, smoking, use of cosmetics or store food for human consumption in the work area,
Xii)
ban pipetting with mouth
Xiii)
provide written instructions for standard operating procedures where needed to guarantee the safety,
Xiv)
have effective disinfectants and special disinfection procedures available in case of spread of GMM,
Xv)
possibly ensure safe storage of contaminated laboratory equipment and materials.
