1

Isolation of animal unit

2

Animal facilities separated by lockable doors

3

Animal facilities designed to facilitate decontamination (waterproof and easily washable material, cages etc.)

4

Floor and/or walls easily washable

5

Floor to wall, wall to ceiling and wall to wall junctions should be rounded for easy cleaning

6

All joints between door frames and wall should be sealed

7

Animal facilities have to be cleaned regularly. Sinks have to be disinfected regularly.

8

Surfaces have to be disinfected after work

9

Used cages have to be decontaminated

10

Material to be sterilised or incinerated as well as used cages have to be transported so that the environment is not contaminated

11

Hands have to be decontaminated and washed if there is the possibility of contamination and after handling animals and waste

12

Access to animal facilities is restricted

13

An animal unit shall have installed devices to detect fires, ventilation and heating failures and the intrusion of unauthorised personnel

14

Where appropriate, an inspection window should be fitted in the door

15

Animal facilities have to be aerated appropriately

16

Wild forms of the animals inside the facility should not be able to enter the facility. Separate male and female of the species to avoid reproductive transmission, unless reproductive studies are part of the experiment

17

Measures to control undesired species such as insects and rodent

18

Drains and any other services that enter through the walls or floor should prevent the ingress of rodents and insects

19

Accidents, bites and scratches caused by animals have to be reported to the project leader who makes a written report

20

Personnel has to be trained in the handling of the animals

21

There have to be written records about the transfer of foreign genes, about the breeding experiments and the disposal of animals

22

Transgenic animals have to be identified easily. The insert can serve as an additional marker

23

Food and tobacco has to be stored so that it cannot come in contact with transgenic animals

24

Protective clothing and shoes have to be worn. They have to be changed or cleaned when the facility is left.

25

Protective clothing has to be stored separated

26

Rodent barrier in front of doors should be installed, alternative doors should be self-closing, to rooms where animals are housed and handled to prevent the escape of animals

27

Animal species shall be housed in appropriate cages, runs, pens suitable for their requirements

28

No animals should be admitted other than for experimental purposes

29

Biohazard sign

30

Doors have to be closed if infected animals are held. There must be a sign indicating the kind of work

31

The laboratory should contain a washbasin with taps that should be of a type that can be operated without being touched by hand, facilities for hand disinfecting shall be provided

32

Use of safety cabinets where aerosols are released

33

An autoclave should be available when genetically modified micro-organisms are used in experiments

34

In experiments where genetically modified micro-organisms are used contaminated material and waste should be inactivated

35

If genetically modified organisms can be transmitted, working tools and equipment have to be sterilised

36

Waste contaminated with genetically modified organisms must only be transported in suitable containers

37

Genetically modified organisms must only be transported in breakproofed and closed containers

38

Where risk assessment indicates the animal room and contents will need to be fumigated the room should be capable of being sealed by appropriate means and consideration should be given to the means of removing or extracting the fumigant

39

Hygiene plan

40

The animal facility has to be entered via a lock equipped with two self closing doors. hand washing basin, disinfection dispenser and shower

41

Acceptability of windows that open

42

Emergency power supply for safety relevant equipment such as ventilation system

43

Where mechanical ventilation is provided, the airflow should be inwards. Air should not be recirculated to any part of the building.

44

The ventilation system should be designed to prevent accidental reverse flow and positive pressurisation in any part of the animal unit

45

In case of work with airborne pathogens negative pressure relative to the pressure of the immediate surroundings, extract air should be HEPA* filtered

46

HEPA* filters should be sited so that they are accessible for testing and allow their safe removal, HEPA filters have to be sterilised on site or immediately sealed in an airtight plastic sack for later sterilisation

47

Animals infected with risk group 3 microorganisms shall be housed in cages in isolators with ventilation passing through HEPA* filtration to the exterior. Alternatively, animals shall be housed in cages within ventilation units with ventilation exhausts placed behind cages.

48

Carcasses have to be sterilised prior to disposal. If this is not possible inside the facility, carcasses have to be transported in closed, leakproofed and disinfected containers

49

Waste water has to be sterilised

1

Greenhouse: permanent structure

2

Internal walls, ceilings and floors shall be resistant to penetration by liquids and chemicals to facilitate cleaning and decontamination of the area. All penetrations into these structures and surfaces shall be sealed (e.g. cables, pipes)

3

Control of contaminated run-off water

4

There, must be a suitable program to control plant pests, weeds, insects and rodents

5

Measures to control undesired species such as weed, insects, rodents, arthropods

6

Procedures for transfer of living material between the glasshouse/growth-room, protective structure and laboratory shall control dissemination of genetically modified micro-organisms

7

Transport of GMOs in suitable closed non-breakable container

8

The container shall be decontaminated if organisms outside are present within the effective dissemination distance of the experimental organism, e.g. by fumigation

9

The ground of the greenhouse can be of gravel or other greenhouse-typical material. At least the pavement should be solid, e.g. of concrete.

10

The ground of the greenhouse should be of water impermeable material. Gravel and other porous material under the planting tables are suitable if there is only a minor possibility that reproducible biological material can be transmitted through the soil. In this case earth beds are also possible.

11

If part of the ground consists of gravel, appropriate treatments should be made periodically to eliminate, or render inactive, any organisms potentially entrapped by the gravel

12

The ground of the greenhouse is made of water impermeable material with provisions to collect and sterilise wastewater.

13

Escape of GMOs

14

Windows shall be closed and sealed

15

All glazing shall be resistant to breakage

16

Biohazard sign at entry

17

A sign shall be posted indicating:- That a restricted experiment is in progress- Name of responsible individual- Plants (organisms) in use- Special requirements for using the area

18

Access is limited to the project leader and personnel authorised by him

19

Protective clothing shall not be worn outside the greenhouse

20

Separate facilities for storing protective and street clothing shall be available

21

Protective clothing has to be sterilised before laundry

22

Gloves shall be worn at work

23

Injuries have to be reported immediately to the project leader

24

There must be written instructions for greenhouse practices and procedures

25

Hand disinfection apparatus and wash basin

26

Greenhouse to be entered via a lock with self-closing doors and hand disinfection apparatus and touch-free hand washing basin

27

Air intake screening and motorised or gravity-driven exhaust fan louvers

28

The glasshouse has to be held under negative pressure compared to the surrounding

29

If there is the danger of the dissemination of airborne pathogens, exhaust air has to be filtered through HEPA-filters

30

Before disposal genetically modified plants have to be made unable to reproduce, e.g. by cutting off blossoms

31

Equipment which was in contact with GMOs has to be sterilised before cleaning, if the contact may lead to the transmission of GMOs

32

Autoclave inside the glasshouse

33

The glasshouse has to be surrounded by a security fence or equal protection system

1

Process with viable micro-organisms separates{ from the environment (closed system)

2.

Laboratory suite isolation

3.

Restricted access to the facility (e.g. electronic cards, camera)

4.

laboratory sealable for fumigation

5.

Acceptability of windows that open

6.

Biohazard sign on the door

7.

Signs at laboratory entrance:- special hazard signs if an organism containing rDNA needs special provision for persons entering the laboratory- names of occupants who have access to the laboratory

8

Ventilation system

1

Surfaces resistant to water, acids, alkalis, solvents, disinfectants, decontamination agents and easy to clean

2.

Suitable of equipment used for safety purposes

3.

Suitable chemical disinfectants in use

4.

suitable position of the autoclave with respect to the genetically modified organism installation

5.

Autoclave provides a print-out showing the temperature and time of sterilisation

6.

Wash hand basin or sink that can be used for hand washing with:- dispenser containing soap- dispenser containing hand disinfectant- paper towels

7.

Appropriate position and design of biological safety hoods

8.

Suitable design of the equipment for the safe storage of genetically modified organisms

9.

suitable design of waste transport containers

10.

Suitable design of containers for the transport of genetically modified organisms inside the facility

11.

Suitable design of centrifuge buckets

12.

Entry to lab via airlock

13.

Air lock with two doors which are interlocked

14.

Air lock equipped with a hand washing basin (touch free) and hand disinfectant dispenser

15.

Negative pressure relative to the pressure of the immediate surroundings

16.

Ventilation system is alarmed to indicate a failure to generate a negative pressure

17.

Ventilation system connected to an emergency power supply

18.

Switch for ventilation system should be accessible from outside of the laboratory in case of fumigation

19.

Extract and input air from the laboratory should be NEPA* filtered

20.

Filters have to be sterilised on site or instantly sealed in a plastic bag for later sterilisation

21.

Alarm systems for workers working alone

22.

Shower for the occupants before leaving the laboratory

23.

An observation window or alternative is to be present so that occupants can be seen

Specification

1

Engineering control measures have to be exercised at source and supplement these with appropriate personal protective clothing and equipment where necessary

2

Control measures and equipment have to be tested adequately and maintained

3

Doors and windows closed while working

4

Access to the laboratory must be restricted when experiments are in progress

5

Workers should be given adequate information on safety matters and be suitably trained. Training should include the following points:a) the existence and application of written work proceduresb) the procedures for using particular pieces of equipmentc) spillage control and other emergency procedures

6

Check at which process steps hazardous quantities of aerosols are formed

7

Prevention of aerosol formation

8

Genetically modified organisms are only to be transported within the facility in closed, robust and leakproof containers

9

Work surfaces must be decontaminated daily and after a spillage

10

Effective disinfectants and specified disinfection procedures in case of spillage of genetically modified organisms

11

Inactivation of genetically modified organisms in contaminated material and waste

12

Inactivation of genetically modified organisms in effluent from the hand washing sinks or drains and showers and similar effluents

13

Benches should be free from clutter

14

The identity of genetically modified organisms should be regularly checked to avoid the culturing of incorrect stains. (The time between these checks should be dependent upon the potential hazard).

15

Corrective actions following the results of the controls and way to register them

16

Users should ensure that the performance of safety equipment is validated (e.g. autoclaves and safety hoods)- validation of equipment (e.g. autoclaves, safety hoods)- maintenance of the equipment- markers used to verify the efficiency of autoclaves

17

Prohibition of mouth pipetting

18

Prohibition of eating, drinking, smoking, applying cosmetics or the storing of food for human consumption in the work area

19

Skin contact with rDNA material must be avoided

20

Hands must be washed after handling rDNA and before leaving the laboratory

21

Protective clothing

22

Decontaminate protective clothing before laundering

23

Protective clothing and street wear must be kept separate

24

Gloves

25

Implementation of an insect and rodent control programme

26

Keep the workplace and environmental exposure to any physical, chemical or biological agent to the lowest practicable level

27

Tests, when necessary, for the presence of viable genetically modified organisms outside the primary physical containment

28

Use of sharps should be avoided

29

Contaminated syringes / sharps must be disposed of in a 'Sharps bin' and incinerated

30

where appropriate make vaccines available

31

Establish Insitutional Biosafety Committees or sub-committees as required

32

Animals must not be allowed to enter into the laboratory

33

Where appropriate serum samples must be taken from workers and stored to provide baseline information in the event of an unexplained illness

34

Sample collection, addition of materials to closed system and transfer of viable microorganisms to another closed system, should be performed appropriate

35

Safe storage of biological agents

36

Safe storage of contaminated laboratory equipment and materials, when appropriate

Specification

1

Keep adequate records

2

Hygiene plan

3

Provide written standard operating procedures where appropriate to ensure safety

4

Provide documentation of the appointment of the BioSafety Officer (BSO)

5

The appointment of project leader

6

A description of the tasks of the BioSafety Officer (BSO) with respect to safety; internal control; accident/incident; response and preparedness; internal counselling, advice and education; and, reporting

7

A description of the tasks of the project leader with respect to:- everyday management- drawing-up and executing work-protocol

8

A clear description of the separation of responsibilities and tasks between the BioSafety Officer and the project leader

9

The status of the BioSafety Officer should be defined

10

There should be written procedures that cover the following:- undertaking risk assessments- the training of new staff- emergency procedures including the treatment of spillages with disinfectants- cleaning and disinfection of equipment- transport of GMOs- operation, testing and maintenance of containment equipment- measures for limiting access to facilities- health surveillance of workers

11

Written instructions should be in both national languages

12

Documents that should be centrally held within an institution undertaking contained use:(a) records indicating working areas and their containment levels (these records may include plans of buildings)(b) all of the documents listed in point 10 above(c) these records should also cover any sites for storage Genetically modified organisms outside of containment facilities(d) records of internally organised inspections(e) records of accidents, including evaluation and any remedial action(f) a list of other data and documents that are held at other locations within the institution

13

Documents that can be held separately from the main records (see 12 above):(a) records of staff involved in contained use indicating their experience and training and the type of projects in which they have been employed(b) results of procedures for checking the purity and identity of the genetically modified organisms(c) results of the testing of containment equipment (e.g. autoclaves and safety cabinets)(d) a list of stored genetically modified organisms for each storage facility(e) work protocols for particular expermental procedures

1

Check contingency plans for protection of the environment and the public outside of the facility

2

Check information on accidents (reporting of accidents and near —misses and records of corrective actions that have been taken)

3

Provide written procedures for:- a procedure for internal notification of incidents (e.g. spillages)- a procedure for external notification in case of serious risk- a procedure accident response (measures, reporting, evaluation)- emergency preparedness actions and countermeasures in case of accidents or incidents

1.0 Name and Contact Address of Applicant

1.1 Date of Submission

1.2 Name of applicant

1.3 Name of Institutional Biosafety Committee (IBC)

1.4 Institution of applicant

1.5 Registration Status in Kenya

1.6 Affiliating institution (if institution of applicant is not registered in Kenya)

1.4.1 Address of applicant's institution

1.6.1 Address of affiliating institution

1.4.2 Telephone

1.4.3 Facsimile /email

1.6.2 Telephone

1.6.3 Facsimile/email

2.1 Brief Description of Proposed contained use activity

2.2 Purpose of contained use - character of the activity that will be carried out by applicant (e.g. research, laboratory control, manufacture)

2.3 If the contained use work is successful, indicate whether a general release of the GMO is planned

2.4 Total period of contained use and date of its expected starting-up

3.1 Summary of the risk assessment for the genes and species of GMO involved.

3.2 Description of potential risks associated with the transformed organism, transformation genes or gene elements.

3.3 Description of potential risks associated with the activities to be undertaken

4.1.1 Facility Location

4.1.2 Approval No. or reference

4.1.3 Number of other contained use activities currently approved within the same facility

4.1.4 Biosafety level assigned to facility during approval (Level 1, or level 2, or level 3 or level 4)

4.1.5 Layout of-premises and of the location of main facilities (Attach additional annex if more space is required)

4.1.6 Code of practice of a workplace (Indicate type)

4.1.7 Emergency Response Plan in the event of an accident

4.1.8 Characteristics of the workplace (Tick as appropriate)

4.1.8.1 Microbiological laboratory

4.1.8.2 Pilot plant

4.1.8.3 Production facilities

4.1.8.4 Glasshouse/growth room

4.1.8.5 Animal breeding facility

4.1.8.6 Other (Specify)

4.1.9 Species and amount of used organism and the used genetic modifications including nominally mentioned validated methods for detection of occurrence of genetically modified organisms.

4.1.10 Waste management plan

4.2.1 Facility Location

4.2.2 Approval No. or reference.

4.2.3 Number of other activities currently approved within the same facility.

4.2.4 Protocol: Fully describe the following

4.2.4.1 Purpose of the greenhouse trial

4.2.4.2 Experimental design

4.2.4.3 Nature and type of data to be collected

4.2.5 Arrangements for transporting the GMO to the greenhouse

4.2.6 Proposed herbicide/pesticide use, if any

4.2.6.1 Name of the pesticide /herbicide

4.2.6.2 Active ingredient

4.2.6.3 Total area to be sprayed (m ² /hectarage)

4.2.7 Provide work schedule (post approval) of key activities including but not limited to:

4.2.7.1 Dates of movement of material

4.2.7.2 Planting (anticipated)

4.2.7.3 Harvest/Sampling (anticipated)

4.2.8 Describe your plan for recording the quantities of seed planted/GMO used and accounting for any excess

4.2.9 Describe the disposition plan, including how and where any excess, or non-planted seed/GMO will be disposed of or stored.

4.2.10 State whether plants will he allowed to set seed or to reproduce

Yes ☐

No ☐

4.2.11 Indicate whether any harvested plant material will be retained from the trial

4.2.11.1 If yes, Type (e.g. seed, leaves, etc.)

Yes ☐

No ☐

4.2.11.2 Quantity to be retained

4.2.11.3 Purpose of retaining material

4.2.12 For harvested plant material, describe the following if applicable:

4.2.12.1 The storage method.

4.2.12.2 Storage location

4.2.12.3 Person in the institution responsible for the storage of the material

4.2.12.3.1 Name

4.2.12.3.2 Telephone

4.2.12.4 Proposed storage records

5.1 Name of GMO

5.2 Modified trait(s) Identification

☐ Herbicide Tolerance☐ Male sterility/restoration☐ Insect Resistance☐ Nutritional change

☐ Modified Oil Composition☐ Virus Resistance☐ Stress Tolerance☐ Fungal Resistance

☐ Pharmaceutical☐ Genetic Research☐ Generation of mutants☐ Other (Specify)

5.3 Modified Trait(s)

Describe each specific new trait associated with this GMO.

5.4 For each gene construct, describe all genes regulatory elements, gene products, non-translated DNA sequences and, where applicable, affected metabolic pathways.

5.5 Provide Information on the donor organism including its origin

5.6 Provide Information on recipient and parental organism including origin

5.7 Provide Information on the vector including its origin

5.8 Provide the name of plasmid (construct) and genetic map (map of each genetic construct is required).

5.9 Describe Mode of action of traits (gene product, metabolic pathways).

5.9.1 Is the vector naturally pathogenic?☐ Yes ☐ No

5.9.2 Is the vector disarmed?☐ Yes ☐ No

5.9.3 If yes, how was the vector disarmed?

5.10 Description of elements of the constructs(s): This area should be filled for all constructs and GMO gene elements

5.10.1 Genetic Element

5.10.2 Size (bp)

5.10.3 Source

5.10.4 Function

5.11 Method of introduction of the insert

5.12 Method for detection of genetically modified organism

5.13 Amount of genetically modified organism to be used (volume of the culture, number of plants or animals)

5.14 Information on whether the genetically modified organism has already been approved in some other country and for what purpose.

6.1 In case of import or export of the genetically modified organism intended for contained use

6.1.1 The country of origin or destination, as appropriate

6.1.2 Importer or exporter, as appropriate

6.1.3 Maximum amount of genetically modified organism to be imported or exported

6.1.4 Means of transportation

6.1.5 Means of packaging and labeling

6.2 Measures to protect human health and the environment and biological diversity

6.3 Frequency and the manner of carrying out control of the occurrence of genetically modified organism inside and outside of the contained space

6.4 Description of waste management plan

7.1 List all protocols proposed to be used at this facility for this application (Separate sheets may be annexed.)

7.2 Attach inspection report if facility is not yet assigned a biosafety level

7.3 State proposed documentation procedures on the use of genetically modified organisms

7.4 Plan of training of employees prior to the commencement of the use of geneticilly modified organisms, and the plan of their refresher training

1.0 Title of Planned Introduction

1.1 Application Type

1.2 Animal/Organism Species Name

☐ New

1.2.1 Latin Name(s)

☐ Renewal

1.2.2 Common Name(s)

1.3 Feed SectionIndicate whether any animal/organism material generated in the contained or confined research trials will be used as research material for livestock feed. ☐ Yes ☐ No

1.4 Applicant1.4.1 Name

1.5 Co-Applicant - Complete if the applicant is not a Kenyan resident1.5.1 Name

1.4.2 Address

1.5.2 Address (Affiliate Institution)

1.4.3 Telephone

1.4.4 Facsimile\Email

1.5.3 Telephone

1.5.4 Facsimile/Email

1.6 Facility Manager (Name, Address and Telephone Number)

1.7 Name of Institutional Biosafety Committee (IBC) - (Attach confirmed minutes of IBC)

1.8 The Proposed Contained or Confined Trial

1.8.1 Brief description of proposed trial1.8.2 What are the aims and objectives of the proposal?1.8.3 What is the intended eventual use(s) of the products?

1.9.1 Describe mechanisms and frequency of intra-and inter-specific out-crossing.

1.9.2 Describe the mechanism of infertility

1.10.1 What is the natural. habitat of the parent animal/organism and its distribution in Kenya?

1.10.2 Where is the origin of the parent animal/organism?

1.10.3 Is the parent animal/organism already present at or near the site of the planned genetically modified organism introduction (s)?

1.10.4 Is the parent animal/organism exotic to Kenya?

1.10.5 Does the unmodified form(s) have any adverse effect on: (please indicate adverse effects)

1.10.5.1 Humans, animals, or plants?

1.10.5.2 Agricultural production? (e.g. pests)

1.10.5.3 Any other aspect of the environment? (e.g. invasiveness)

1.10.5.4 List any locations in Kenya or elsewhere where the animal/organism is a known pest.

1.11.1 Tendency to propagate uncontrollably

1.11.2 Dormancy

1.11.3 Body tissues/fluid dispersal (animals only)

1.11.4 Persistence or dispersal of reproductive structures such as larvae and eggs

1.11.5 Other dispersal mechanisms

1.12.1 List any known toxins produced by this animal/organism, including natural defence compounds.

1.12.2 Indicate the levels at which these compounds induce toxicity.

1.12.3 Indicate the species affected by these toxins.

1.13.1 List any known allergens that emanate from this animals/organisms, including natural defence compounds.

1.14 Please describe any other pathological, ecological and physiological traits that relate to the animal/organism Novel Trait (NT) but not the unmodified animal/organism. A few suggestions of the required information are as described below:• Generation time in natural ecosystems, sexual and asexual reproductive cycle• Pathogenicity: infectivity, virulence, infective dose, communicability, possibility of survival outside of human, (toxigenicity, allergenicity = already given), carrier (vector) or means of dissemination of pathogen, biological stability, host range including non-target organisms. Possible activation of latent viruses (proviruses), availability of possible therapies, etc.• Antibiotic resistance and potential use of the antibiotics in humans and domestic organisms• Involvement in environmental processes, e.g. primary production, nutrient turnover, decomposition of organic matter, etc

2.1 Name or Designation of animal or organism Novel Trait (NT)

2.2 Novel Trait(s) Identification (Tick as appropriate)

☐ Genetic Research.

☐ Pharmaceutical.

☐ Generation of mutants.

☐ Insect Resistance.

☐ Stress Tolerance

☐ Fungal Resistance.

☐ Nutritional change.

☐ Increased production of milk or wool

☐ Genes knocked out to allow xeno transplantation

☐ Faster, more efficient growth rates

☐ Increased tolerance to cold water for fish.

☐ Improved meat, milk or wool quality

☐ Leaner, more tender beef and pork.

☐ Resistance to diseases caused by viruses,bacteria and other pathogens.

☐ Milk that lacks allergenic proteins, or results in increased amounts of cheese and yogurt.

☐ Development of animals that serve as models for human diseases to help scientists better understand prevention and treatment strategies.

☐ Possession of characteristics whichare environmentally friendly e.g. improved use of dietary phosphorous to lessen the environmental impacts of animal manure

☐ In the phylogenetic analysis of theamplified nucleic acid sequences to provide novel information on the evolution of pathogens.

☐ Animal vaccines rationally designed for the specific control and eradication of diseases, including the implementation of DIVA (differentiating infected from vaccinated animals) strategies.

☐ Development of diagnostic kits that can not only be used in the laboratory but pen-side tests that can be used in the field to make decisions about the exposure of animals during a disease outbreak.

☐ In epidemiology to characterize pathogens through determination of their nucleotide sequence. The possibility of pinpointing the source of infection can significantly contribute to improved disease control.

☐ Cloning to enable the rapid dissemination of superior genotypes from nucleus breeding flocks and herds, directly to commercial farmers. Genotypes could be provided that are ideally suited for specific product characteristics, disease resistance, or environmental conditions.

☐ Cloning to help salvage the germplasm of indigenous species that are near extinction, including intra-species nuclear transfer procedures which can be used to rescue genes from endangered species.

☐ New and improved medicines for animals. e.g. Gene therapy which involves the insertion of a functional gene or another molecule that contains an information sequence into a cell to achieve a therapeutic effect. Thus, the gene serves as a drug.

☐ Producing large amounts of therapeutic - proteins in animal milk or meat (biopharm animals or transgenic animal bioreactors) may be an efficient, relatively low cost method to manufacture many proteins used to treat human diseases or proteins that have industrial value.

☐ In the development of novel diagnostic assays, e.g. PCR and isothermal amplification methods, microarrays, protein detection by nucleic acid amplification, recombinant proteins, synthetic proteins, biosensors etc. to detect the pathogens and/or the immune responses after infection.

☐ Other (Specify)

2.3 Novel Trait(s)

Describe each specific novel trait associated with this animal or organism.

2.4. Is GMO Imported or generated locally.

2.4.1 Import Permit No. If the animal or organism novel trait is imported, provide the import permit number issued under the Animal Diseases Act (Cap. 364 ) or any other appropriate legislation.

2.5 HistoryHas this genetically modified organism been previously tested in Kenya? If yes, please provide information on trial (s), year(s) of authorization and location(s) tested.☐ Yes ☐ No

2.6.1 Describe Induction Method (mutagenesis) or Transformation Method (recombinant techniques).

2.6.2 Describe Selection Method.

2.6.3 Describe Mode of action of traits (gene product, metabolic pathways).

2.6.4 OtherProvide details of modification by means other than mutagenesis or recombinant techniques.

Indicate the gene's donor organism (for animals or organisms transformed using recombinant techniques).

2.8.1 Name of plasmid (construct) and genetic map (map of each genetic construct required).

2.8.2 Is the vector naturally pathogenic? (Tick appropriate)☐ Yes☐ No

2.8.3 Is the vector disarmed? (Tick as appropriate)☐Yes☐No

2.8.4 If yes, how was the vector disarmed?

2.8.5 For each gene construct, describe all genes, regulatory elements, gene products, non-translated nucleic acid (DNA/RNA) sequences and, where applicable, affected metabolic pathways.

2.8.5.1 Description of elements of the constructs(s): This area should be filled for all constructs and GMO gene elements

2.8.5.1.1 Genetic Element

2.8.5.1.2 Size (bp)

2.8.5. 1.3 Source

2.8.5.1.4 Function

2.9.1 Spatial and Temporal Trait Expression

Trait

Expression

2.9.1.1 Constitutive (Yes/No)If not constitutive, indicate the specific tissue(s) in which the trait is expressed (green tissue, seed, pollen, roots, other)

2.9.1.2 Is the trait expressed during specific developmental stage?If yes, when?

2.9.1.31s the trail inducible?If yes, how?

2.10.1 To what extent are novel gene products toxic when ingested by native fauna populations, including mammals, birds, reptiles, and insects? How has this been determined?

2.10.2 To what extent are novel gene products allergens? How has this been determined?

2.11.1 Tendency to propagate uncontrollably

2.11.2 Dormancy

2.11.3 Body tissues/fluid dispersal (animals only)

2.11.4 Persistence or dispersal of reproductive structures such as larvae and eggs

2.11.5 Other dispersal mechanisms

2.11.6 What is the frequency of reversion, i.e., loss of genetic modification?

2.11.7 How do you verify that you have the desired GMO?

2. 11.8 What methods are to be used to test for batch-to-batch consistency'?

2.12.1 Has the facility been inspected by the relevant regulatory agency?

☐Yes

☐ No

Please attach the facility inspection approval letter/certificate

1 Trial Protocol (Study)

Title:

2 Protocol

Prescribe fully the purpose of the trial, the experimental design, the nature and type of data to to be collected and arrangements for transporting the GMO to the trial site. Please dude proposed, if any, herbicide/pesticide use.

3 Provide work schedule (post approval) to include:

3.1 Intervention (anticipated)

3.3.2 Sampling (anticipated)

3.4 IsolationSite the isolation measures being implemented for this trial and give details.

3.5 Method of introduction of GMO into parent where applicable

3.6 Spraying/Dipping*

Please complete this section if the trial site is subject to the use of an unregistered product, or a registered product used for a non-registered purpose.

3.6.1 Name of the pesticide 3.6.2 Total area sprayed (Square meters) 3.6.3 Active ingredient* This information is also required to determine compliance with the Pest Control Products Act3.6.4 Unregistered Pesticide Use Indicate whether the trial site location will be subject to unregistered pesticide use.☐Yes ☐No

3.7.1 Will animal/organism be allowed to reproduce?

3.7.2 Describe the method of harvest for microbial cultures, embryos and other animal material

Yes☐

No☐

3.7.3 Will any material be retained from the trial?

3.7.4 If yes,

Yes☐

No☐

3.7.4.1 Type of material to be retained

3.7.4.2 Quantity to be retained

3.7.4.3 Purpose of retaining material.

3.7.5 Describe the storage method and storage location of harvested material.

3.7.6 Provide the name, address and phone number of the contact person responsible for the storage of the material and the proposed storage records.

3.7.7 Describe your management plan to avoid escape of GMO from the trial site

3.8.1 Describe your disposal plan for all material; including how and where the material will be disposed of.

3.8.2 Provide the name, address and phone number of the contact person responsible for the disposal of the material and the proposed disposal records.

3.9.1 Describe your contingency plan in the case of accidental release of GMO material or the breakdown of isolation/quarantine.

3.10.1 Describe the extent.and frequency of trial site monitoring during the course of the trial.

3.10.2 Describe the extent and frequency of trial site monitoring during the post-trial period.

3.10.3 Describe what monitoring results will be recorded, how they will he recorded and who is responsible for them.

3.10.4 If any controlled monitoring procedures are proposed for this trial, detail these.

3.10.5 Describe the provisions to remove or eliminate the GMO from the test site or any other place where it may be found upon completing the trial release and to restore the test site and any such other place to its status quo.

4.1 Town/City (Nearest city)

4.2 Province

4.3 Legal Land Location (The NBA will not authorize a confined field trial unless the trial site has been inspected and approved)

4.4 Field Manager (Must be a Kenyan resident and responsible for the trial site location)

4.5 Trial Size Trial size in meters²

4.4.1 Name

4.4.2 Address

4.6 Map location Has a complete map location of the trial site been provided?

Yes ☐

No ☐

4.4.3 Telephone

4.4.4 Facsimile

A map and GPS coordinates of the trial site must be received by the NBA within 7 days following commencement of the trial.

4.7.1 Describe the biological diversity of the trial site, including:

4.7.1.0 Potential impacts resulting from the field test

4.7.1.1 Soil

4.7.1.2 Groundwater level

4.7.1.3 Topography

4.7.1.4 Flora and fauna

4.7.1.5 Climate, especially prevailing winds and temperature

4.7.1.6 Former use of the facility

4.7.1.7 Distance from nearest human settlements

4.7.1.8 Distance from surface water body

4.7.2 Is the trial site part of a managed ecosystem

4.7.3 If yes, how close is the nearest natural

Yes☐

No☐

4.7.4 How close is the site from an area of special ecological interest, including protected areas and sanctuaries?

4.8.1 Specify the related wild and domesticated species/organisms present at the trial site and how close they are to the novel animal/organism material under test.

4.8.2 Are there any endangered species on or near the site?

4.8.3 If yes, please list.

Yes☐

No☐

For information on endangered species that may be near the trial site location, contact the Kenya Wildlife Service; P.O. Box 40241 NAIROBI, Email: kws@kws.org, Website: www.kws.org, Langata Road, Telephone (+245-20-501081.

4.8.4 What mechanisms are in place to prevent the local fauna from removing novel plant/animal/organism material from the site?

4.9.1 Name and address of the person(s) having control over the site during the post-trial land use period.

4.9.2 What is the anticipated post-trial land use?

4.9.3 Describe how the site boundaries will be marked to facilitate subsequent inspection.

Submission (Animal or organism novel trait designation — List of possible designations/unique identifier)

Trial Protocol(s)

4.11.1 How will you provide public notification of your proposed field trial?

1.1 Application Type

1.2 Plant Species Name

1.2.1 Latin Name(s)

☐ New☐ Renewal☐ Date of submission of the application

1.2.2 Common Name(s)

(Indicate if perennials, annuals, trees etc.)

1.3 Feed SectionIndicate whether any plant material generated in the confined field trials will be used as research material for livestock feed.

Yes ☐

No ☐

1.4 Applicant

1.5 Name of Institutional Biosafety Committee.(Attach signed minutes of Institutional Biosafety Committee discussions)

1.4.1 Name

1.5.1 Institution of applicant

1.5.2 Registration Status in Kenya

1.5.2.1 Affiliating institution (if institution of applicant is not registered in Kenya)

1.4.2 Address

1.5.3 Address

1.4.3

1.4.4

1.5.3

1.5.4 Facsimile/email

Telephone

Facsimile/email

Telephone

1.6.1 Brief Description of Proposed Trial

1.6.2 Objective

1.6.3 What is the aim of the proposed trial of the genetically modified organism?

1.6.4. What are the benefits of this approach compared with other possible methods, especially those not involving planned trial?

1.6.5 If the trial is successful, do you intend to propose a general release of the GMO?

1.6.6 Summary of the risk assessment

1.7.1 Describe mechanisms and frequency of intra-and inter-specific out-crossing.

1.7.2 Describe the mechanism of infertility

1.8.1 Tendency to weediness

1.8.2 Allelopathy

1.8.3 Dormancy

1.8.4 Pollen dispersal

1.8.5 Seed dispersal

1.8.6 Vegetative dispersal

1.8.7 Other dispersal

1.8.8 Other Characteristics

1.9.1 List any known toxins from this species, including natural defence compounds.

1.9.2 Indicate the levels at which these compounds induce toxicity.

1.9.3 Indicate the species affected by these toxins.

1.10.1 List any known allergens for this species, including natural defence compounds.

1.11 Describe any pathological, ecological and physiological traits that relate to thegenetically modified organism but not to the unmodified plant.

Fill out section 2 for each individual submission (genetic modification of that particular species) included in the application.

2.1 Name or Designation of genetically modified organism

2.2 Modified trait(s) Identification

☐ Herbicide Tolerance☐ Male sterility/restoration☐ Insect Resistance☐ Nutritional change

☐ Modified Oil Composition☐ Virus Resistance☐ Stress Tolerance☐ Fungal- Resistance

☐ Pharmaceutical☐ Genetic Research☐ Generation of mutants☐ Other (Specify)

2.3 Modified Trait(s)Describe each specific novel trait associated with this genetically Modified organism.

2.4 Status of authorization2.4.1 Is genetically modified organism Imported or generated locally.

2.4.2 If imported, provide the import permit number issued under any other authorization.

2.5 HistoryHas this Genetically Modified Organism been previously tested in Kenya?

☐ Yes☐ NoIf yes, please provide information on trial (s), year(s) of authorization and location(s) tested.

2.6.1 Describe Introduction Method(s).

2.6.2 Describe Trait Selection Method.

2.6.3 Describe Mode of action of traits (gene product, metabolic pathways).

2.6.4 Other techniques of modificationProvide details of modification by means other than mutagenesis or recombinant DNA techniques.

Indicate the gene donor organism(s) (for plants transformed using rDNA techniques).

2.8.1 Name of plasmid (construct) and genetic map (map of each genetic—construct required).

2.8.2 Is the vector naturally pathogenic?☐ Yes ☐ No

2.8.3 Is the vector disarmed?☐ Yes ☐ No

2.8.4 If yes, how was the vector disarmed?

2.8.5 For each gene construct, describe all genes, regulatory elements, gene products, non-translated DNA sequences and, where applicable, affected metabolic pathways.

2.9.1 Spatial and Temporal Trait Expression

Trait

Expression

2.9.1.1 Constitutive☐ Yes ☐ NoIf not constitutive, indicate the specific tissue(s) in which the trait is expressed (green tissue, seed, pollen, roots, other

2.9.1.2 Is the trait expressed during specific developmental stage?☐ Yes ☐ NoIf yes, when?

2.9.1.3 Is the trait inducible?☐ Yes ☐ NoIf yes, how'?

2.10.1 To what extent are transformed gene products toxic when ingested by native faunaPopulations, including mammals, birds, reptiles, and insects?

2.10.1.1 How has this been determined?

2.10.2 To what extent are transformed gene products allergens?

2.10.2.1 How has this been determined?

2. 11.1 Persistence and invasiveness

2.11.2 Allelopathy

2.11.3 Dormancy

2.11.4 Pollen Dispersal

2.11.5 Seed Dispersal

2.11.6 Vegetative Dispersal

2.11.7 Any other Dispersal Mechanism

2.11.8 Any other altered characteristic (s)Are any of the likely gains directly linked to losses in other characteristics of thespecies?

2.11.9 Please describe if any toxins and allergens are produced by the GMO that were notproduced by the unmodified plant

2.11.10 What is the frequency of reversion, i.e., loss of genetic modification?

2.11.11 How do you verify that you have the desired GMO?

2.11.12 What methods are to be used to test for batch-to-batch consistency?

2.12.1 Town and Province

2.12.2 Legal land location

2.12.3 Trial Protocol(s) (Attach trial Protocol)

3.1 Town/City (Nearest city)

3.2 Province

3.3 Legal Land Location (The National Biosafety Authority will not authorize a confined field trial until the legal land location of the trial site has been given)

3.4 Field Manager responsible for the trial site3.4.1 Name (Must be affiliated to a research institution registered in Kenya)

3.4.2 Address

3.4.3 Telephone

3.4.4 Facsimile

3.5 Trial SizeTrial size in meters²/Hectarage

3.6 Location Map Attach a complete map (including GPS coordinates) of the location of the trial site

3.6.1 Has the suitability of the contained use facility to conduct contained use activity been assessed.

3.7.1 Describe the biological diversity of the trial site, including:

3.7.1.0 Potential impacts resulting from the field test

3.7.1.1 Soil

3.7.1.2 Groundwater level

3.7.1.4 Topography

3.7.1.5 Flora and fauna

3.7.1.6 Climate, especially prevailing winds direction and Temperate

3.7.1.7 Previous use of the facility

3.7.1.8 Distance from nearest human settlements

3.7.1.9 Distance from surface water body

3.7.2 Is the trial site part a of a managed ecosystem?

3.7.3 If yes, how close is the nearest natural ecosystem?

Yes ☐ No ☐

3.7.4 How close is the site from an area of special ecological interest, including protected areas and sanctuaries?

3.8.1 Specify the related wild and domesticated species/organisms present at the trial site and how close they are to the modified plant material under test.

3.8.2 Are there any endangered species on or near the site?

3.8.3 If yes, list

Yes☐ No ☐

NB: For information on endangered species that may be near the trial site location, contact the Kenya Wildlife Service, P.O. Box 40241 NAIROBI, Email: kws@kws.org, Website: www.kws.org, Langata Road, Telephone +245-20-501081.

3.8.4 What mechanisms are in place to prevent the local fauna from removing the modified plants material from the site?

3.9.1 Person(s) having control over the site during the post-harvest/trial land use period, including the isolation area

3.9. 1.1 Name

3.9.1.2 Address

3.9.1.3 Telephone

3.9.1.4 Facsimile

3.9.2 Describe how the site boundaries will be marked to facilitate subsequent inspection.

3.10.1 Submission (genetically modified organism designation — List of possible designations/unique identifier)

3.10.2 Trial Protocol(s)

4.1 Trial Protocol (Study)Title:

4.2 Protocol4.2.1 Fully describe the following

4.2.2 Purpose of the field trial

4.2.3 Experimental design

4.2.4 Nature and type of data to be collected

4.2.5 Arrangements for transporting the GMO to the trial site

4.2.6 Proposed, if any, herbicide/pesticide use

4.3.1 Planting (anticipated)

4.3.2 Harvest/Sampling (anticipated)

4.4 IsolationState the isolation measures being implemented for this trial and give details

4.4.1 If using bags or nets, please provide the mesh size of the material being used and justify the effectiveness.

4.5.1 Material will he planted by:

4.5.2 Will any unmodified plants of the same or a related species be planted at the trial site location?

4.5.1.1 Hand ☐Or4.5.1.2 Mechanically ☐

4 5.3 if yes, state reason

4.5.4 Describe your management plan to avoid the dissemination, e.g. of seed, from the trial site.

4.5.5 Describe your plan for recording the quantities of seed planted/GMO used and accounting for any excess

4.5.6 Describe the disposition plan, including how and where any excess. or non-planted seed/G MO will be disposed of or stored.

4.6.1 Registered pesticide for unregistered use

4.6.1.1 Name of the pesticide

4.6.1.2 Total area to be sprayed (m²/hectarage)

4.6.1.3 Active ingredient

4.6.2 Unregistered Pesticide Use

Yes ☐ No ☐

4.6.2.1 Name of the pesticide

4.6.2.2 Total area to be sprayed (//m²/hectarage//)

4.6.2.3 Active ingredient

* This information is required to determine compliance with the Pest Control Products Act (Cap 346).

4.7.1 Will plants be allowed to set seed or to reproduce?Yes☐ No ☐

4.7.2 Describe the method of harvest for seed and other plant material (e.g. by hand, small plot combine, etc.)

4.7.3 Will any harvested plant material be retained from the trial?Yes ☐ No ☐

4.7.4 Material retention If yes4.7.4.1 Type (e.g. seed, leaves, etc.)

4.7.4.2 Quantity to be retained

4.7.4.3 Purpose of retaining material

4.7.5 For harvested plant material, describe the following if applicable:4.7.5.1 The storage method.

4.7.5.2 Storage location

4.7.6 Person responsible for the storage of the material

4.7.6.1 Name

4.7.6.2 Address

4.7.6.3. Telephone

4.7.6.4 Facsimile

4.7.6.5 Proposed storage records

4.7.7 Describe how the site boundaries will be marked to facilitate subsequent inspection.

4.7.8 Describe your management plan to avoid dissemination of seed/GMO from the trial site during harvesting.

4.8.1 Describe your disposal plan for all propagules and non-propagule plant material; including how and where the material will be disposed of.

4.8.2 Person responsible for the disposal of the material

4.8.2.1 Name

4.8.2.2 Address

4.8.2. Telephone

4.8.2.4 Facsimile

4.8.2.5 Proposed disposal records

4.9.1 Describe your contingency plan in the case of accidental release of seed/GMO plant material (e.g. spills), or the breakdown of isolation.

4.9.2 Describe your contingency plans if after accidental release there is unexpected spread of the transformed plant material.

4.10.1 Describe the extent and frequency of trial site monitoring during the course of theField trial.

4.10.2 Describe the extent and frequency of trial site monitoring during the post-trialperiod.

4.10.3 Person responsible for monitoring

4.10.3.1 Describe what monitoring results will be recorded

4.10.3.2 Describe how monitoring results will be recorded

4.10.4 If any controlled monitoring procedures are proposed for this trial (e.g. planting of unmodified plants of a related species to determine possibility and frequency of gene flow), detail these.4.10.5 Describe the provisions to remove or eliminate the GM° from the test site or any other place where it may be found upon completing the trial and to restore the test site and any such other place to its status quo.

4.11.1 How will you provide public notification of your proposed field trial?

Trial site location

Legal land location

Town

Number of hectares

APPROVALNUMBER ________

DATE OFISSUE __________VALID UPTO _______________

In accordance with regulation 9 of the Biosafety (Contained Use) Regulations, of the Biosafety Act, I hereby grant the approval to undertake contained use activity of the genetically modified organism herein stated in the research institution mentioned in this approval.

Name of the Applicant/ Research Institution

Specification of the genetically modified organism

Quantity approved

Specification of the genetic modification

Risk category

Purpose of the use

This approval is granted subject to the following Conditions-1. _________________________2. _________________________3. _________________________4. _________________________

This approval is not transferrable and is valid for:

Place:

Name:Signature:The Chief Executive Officer National Biosafety Authority

Date

1.0 Name of the Applicant

2.0 Address of the Work place

3.0 Accurate identification of premises, sites and facilities where the genetically modified ' organisms are used and the accurate identification of the place, premises, sites or facilities are situated (describe and attach map)

4.0 Plan of the workplace with identification of places that are important for the reduction of accident consequences, places of storage of genetically modified organisms, protective measures of the contained space

5.0 Description of an accident that can occur in space or place where the genetically modified organism is used

6.0 Review on possible accident impacts on human health and the environment, including the methods for detection of such impacts and effective protection from the impacts

7.0 Validated procedures for the detection of presence of genetically modified organisms

8.0 Validated methods and procedures available for liquidation of genetically modified organisms and for decontamination of an affected space

9.0 Methods of isolation of spaces and facilities affected by accident including methods of control of isolation effectiveness

10. Methods of disposal or remediation of plants and animals that were in the affected area at the time of the accident

11. Description and layout of decontamination agents available to liquidate genetically modified organisms and decontaminate an affected space

12. Procedures for protection of human health and the environment in case of undesirable effects of an accident

13. Description of the procedure of subsequent monitoring of sites and premises after the termination of a decontaminated process

14. Persons to whom the contingency plan is submitted to

15. Manner of notification of an accident to the Authority and relevant regulatory agency including the manner of warning the inhabitants on its possible consequences

16.0 Undertaking of the applicant (attach affidavit)

16.1 Name

Signature