Biosafety (Contained Use) Regulations, 2011 (L.N. No. 96 of 2011)

LEGAL NOTICE NO. 96 THE BIOSAFETY ACT, 2009 (No. 2 of 2009) THE BIOSAFETY (CONTAINED USE) REGULATIONS, 2011 ARRANGEMENT OF REGULATIONS Regulations. PART I—PRELIMINARY 1—Citation. 2—Interpretation. 3—Objective. 4—Exceptions. PART II—CONTAINMENT MEASURES 5—Classification of containment levels. 6—Institutional Biosafety Committee. 7—Application for contained use. 8—Consideration of application. 9—Approval. 10—Validity of the approved activity. 11—Suspension or revocation of approval. 12—Handling of new information. 13—Contingency plan. 14—Contents of contingency plans. 15—Emergency measures. PART III—MISCELLANEOUS 16—Information sharing and records. 17—Registration of decisions in the National Biosafety Clearing House. 18—Confidential information. 19—Good containment measures. 20—Handling of modified plasmids and vectors. 21—Penalties. SCHEDULES First Schedule: — Techniques which do not lead to genetically modified organisms. Second Schedule: — Classification of Containment Levels. Third Schedule: — Application forms for contained use. Fourth Schedule: — Approval to conduct contained use activity using genetically modified organisms. Fifth Schedule: — Contingency plan. THE BIOSAFETY ACT, 2009 (No. 2 of 2009) IN EXERCISE of the powers conferred by sections 51 of the Biosafety Act, 2009, the Minister for Higher Education, Science and Technology with confirmation of the Board makes the following Regulations― THE BIOSAFETY (CONTAINED USE) REGULATIONS, 2011 PART I—PRELIMINARY Citation. 1. These Regulations may be cited as the Biosafety (Contained Use) Regulations, 2011. Interpretation. 2. In these Regulations unless the context otherwise requires— ‘accident’ means any incident involving a significant and unintended release of genetically modified organisms in the course of their contained use which could present an immediate or delayed hazard to human health and the environment; ‘applicant’ means a person making an application under these Regulations; ‘Authority’ means the National Biosafety Authority established under section 5 of the Act; ‘Biosafety Clearing-House’ means a mechanism for exchange of scientific, technical, environmental, socio-economic and legal information and experience with genetically modified organism; ‘confined field trial’ means any activity undertaken within a field and which involves genetically modified organisms which are controlled by specific measures to ensure safety for humans and for the environment; ‘contained use’ means any activity undertaken within a facility, installation or other physical structure, which involves genetically modified organisms which are controlled by specific measures; ‘contained use premises’ includes a facility, field, installation or other physical structure in which contained use is undertaken; ‘Institutional Biosafety Committee’ means a committee established under regulation 6 of these Regulations; ‘genetically modified organism’ means an organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques; ‘modern Biotechnology’ includes the application of (a) in-vitro nucleic acid techniques including the use of recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles; or (b) fusion of cells beyond the taxonomic family, that overcome natural physiological, reproductive and recombinant barriers and which are not techniques used in traditional breeding and selection. ‘regulatory agency’ means a regulatory agency as set out in the First Schedule to the Act, or such other agency as the Minister may, by Order in the Gazette, determine. ‘research institution’ includes a university, or any other research institution registered in Kenya or established under a written law, carrying out research involving genetically modified organisms; ‘screening for completeness’ means the evaluation of an application to ensure that all the administrative as well as technical requirements are met. Objective. 3. The objective of these Regulations is to ensure that potential adverse effects of genetically modified organisms are addressed to protect human health and the environment when conducting contained use. Exceptions. 4. These Regulations shall not apply— (a) to genetically modified organisms which are pharmaceuticals for human use ; (b) where genetic modification is obtained through the use of the techniques or methods listed in the First Schedule; (c) to the storage, culture, transport, destruction, disposal or use of genetically modified organisms which have been released into the environment in accordance with the Biosafety (Environmental Release) Regulations, 2011. PART II—CONTAINMENT MEASURES Classification of containment levels. 5. (1) The Authority shall ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment, which might arise from the contained use of a genetically modified organism. (2) The Authority in consultation with the relevant regulatory agency shall assess the suitability of a contained use premises to conduct contained use activity involving genetically modified organism. (3) Upon carrying out the assessment, the Authority in consultation with the relevant regulatory agency shall determine the containment level of the contained use premises in accordance with the provisions of the Second Schedule. (4) The containment levels under this Regulation apply to laboratory, greenhouse or screen house activities. (5) Appropriate measures for confined field trials shall be determined through procedures developed by the Authority in consultation with the relevant Regulatory Agency. Institutional Biosafety Committee. 6. (1) A research institution undertaking contained use activities shall establish an Institutional Biosafety Committee. (2) An Institutional Biosafety Committee shall consist of (a) biosafety officer(s); (b) scientist(s) in the relevant field; (c) representative(s) of technical staff; (d) representative(s) of laboratory management; (e) representative(s) of the community where the premises are situated; and (f) representative(s) of the relevant regulatory agency. (3) The functions of an Institutional Biosafety Committee shall be (a) to prepare applications for contained use activities and refer the applications to the Authority for approval; (b) to advise the research institution on matters relating to biosafety; (c) to assist the institution in the establishment of the appropriate monitoring mechanisms for risk assessments and risk management; (d) to ensure compliance with the conditions set out in the approval; (e) to review and ascertain the suitability of both physical and biological containment and control procedures appropriate to the level of assessed risk involved in research, development and application activities; (f) to advice the institution and principal investigators on mitigation measures to be undertaken in case of an accident. (4) A person shall not carry out contained use activity under these Regulations unless such activity is carried out within, or in collaboration with, a research institution. (5) A person who contravenes sub regulation (4) commits an offence. Application for contained use. 7. (1) A person shall not undertake contained use without the written approval of the Authority. (2) An application for contained use shall be made to the Authority through an Institutional Biosafety Committee. (3) An application for contained use shall be in the form set out in the Third Schedule to these Regulations and shall be accompanied by an application fee of one hundred and seventy thousand shillings. (4) A person who contravenes sub regulation (1) commits an offence. Consideration of application. 8. (1) Upon receipt of an application under regulation 7, the Authority shall screen for completeness and circulate the application to the relevant regulatory agencies for further information, comments or reasoned objections. (2) The Authority shall examine the application to confirm (a) that the application conforms with the requirements of these Regulations; (b) the accuracy and completeness of the information given; (c) the risk assessment submitted by the applicant; (d) the level of contained uses; and (e) where appropriate, the suitability of the containment and other protective measures, the waste management, and contingency measures. (3) The Authority may (a) require the applicant to provide further information; or (b) require the applicant to modify the conditions of the proposed contained use, or to amend the level assigned to the contained use; or (c) limit the time for which the contained use should be permitted or subject it to certain specific conditions. (4) The Authority shall communicate its final decision within one hundred and fifty days of receipt of the application but not earlier than ninety days of such receipt. (5) For the purpose of calculating time, any period of time during which the Authority is awaiting any further information that it may have requested from the applicant shall not be taken into account. Approval. 9. (1) An approval for contained use shall be in the form set out in the Fourth Schedule. (2) An approval granted under these Regulations shall be valid for the period of the activity in respect of which it is granted. (3) An approval for contained use is not transferable. Validity of the approved activity. 10. (1) An approval under these Regulations shall be for the period of the activity. (2) A grantee under these Regulations shall submit quarterly reports on the progress of the activity during the period of the approved activity. Suspension or revocation of approval. 11. (1) The Authority may suspend or revoke an approval granted under these Regulations, where the grantee is in contravention of the provisions of these Regulations. (2) The Authority shall, before suspending or revoking an approval, give a written notice to the grantee to put in place such appropriate containment measures or other protective measures. Handling of new information. 12. (1) A grantee who subsequently becomes aware of information which could have significant consequences for the risks posed by it, shall inform the Authority of such information as soon as possible. (2) A person who withholds any information that becomes available before and after the approval of the application, and which could reasonably be expected to change the evaluation of the risk posed by the activity, commits an offence and is liable on conviction to a fine not exceeding two million shillings or imprisonment for a term not exceeding ten years, or both. (3) Where information which could have significant consequences for the risks posed by the contained use, subsequently becomes available, the Authority may require the grantee to modify the conditions of, or suspend or terminate, the contained use. (4) A grantee, who wishes to request for an extension or to modify the contained use, may make a written request to the Authority and the Authority shall within thirty days acknowledge receipt of the request. (5) The Authority shall review the request and where it considers that the proposed extension or modification ─ (a) does not require risk assessment, the Authority shall communicate its decision within thirty days from the date of the receipt of the request; or (b) may have material effect on the outcome of the risk assessment upon which the decision was based, the Authority shall, if is satisfied that a change is warranted, make a decision within one hundred days from the date of the receipt of the request. Contingency plans. 13. The Authority shall ensure that before contained use commences— (a) the applicant draws up a contingency plan for contained use to mitigate against risk, whether immediate or delayed, to humans outside the premises or to the environment as a result of failure of the contained use measures; (b) Information on such contingency plans, including the relevant safety measures to be applied, is supplied, to the relevant regulatory agency for purposes of monitoring for compliance. Contents of contingency plans. 14. Every contingency plan shall be in the form set out in the Fifth Schedule. Emergency measures. 15. (1) In the event of an accident, a grantee shall inform the Authority immediately and shall provide the following information (a) the circumstances and location of the accident; (b) the identity and quantities of the genetically modified organisms; (c) any information necessary to assess the effects of the accident on human beings, and the environment; and (d) the measures taken to mitigate against risk. (2) Where information is given pursuant to sub regulation (1), the Authority shall— (a) ensure that necessary measures are taken to control the effects of the accident; (b) where possible, collect, information necessary for a full analysis of the accident; and (c) where appropriate, make recommendations on how to avoid a similar accident in the future and to limit the effects thereof. (3) A person who contravenes sub regulation (1) commits an offence. PART III—MISCELLANEOUS Information sharing and records. 16. (1) The Authority shall maintain a register which shall contain— (a) a copy of the— (i) application; (ii) risk assessment document; (iii) decision document; (iv) approval document; and (v) contingency plan; (b) a list of institutional biosafety committees; and (c) any other information that the Authority may deem necessary. (2) The register shall be open for inspection by any interested person upon payment of an inspection fee of five hundred shillings. (3) The Authority shall establish a procedure for the exchange of information and experiences gained. Registration of decisions in the National Biosafety Clearing House. 17. The Authority shall register all decisions made under these Regulations in the National Biosafety Clearing House within thirty days of making the decision. Confidential information. 18. (1) An applicant may request that certain information in his application be treated as confidential and shall give reasons for the request. (2) The Authority shall determine if the information should be kept confidential and shall communicate its decision to the applicant in writing. (3) The following information shall not be considered confidential─ (a) name and address of the applicant; (b) the general characteristics of the genetically modified organism; (c) class of contained use and measures of containment; and (d) the evaluation of foreseeable effects, in particular any harmful effects on human health and the environment. (4) The authority shall protect the intellectual property rights of the applicant. (5) Where an applicant withdraws an application, the Authority shall maintain confidentiality on the information supplied. Good containment measures. 19. An applicant shall apply the general principles and the appropriate containment and other protective measures set out in Part II of the Second Schedule to these Regulations corresponding to the class of the contained use. Handling of modified plasmids and vectors 20. Modified plasmids or vectors used as tools for modern biotechnology shall be approved by the relevant regulatory agency. Penalties 21. A person who contravenes any of the provisions of these Regulations commits an offence and is liable on conviction to a fine not exceeding twenty million shillings or to imprisonment for a term not exceeding ten years, or both. FIRST SCHEDULE (r. 4) TECHNIQUES WHICH DO NOT LEAD TO GENETICALLY MODIFIED ORGANISMS The following technical procedures shall not be considered to amount to formation of genetically modified organisms without concurrent use of recombinant heritable genetic material─ (a) in vitro fertilization; (b) bacterial conjugation, transformation, transduction and similar natural processes; (c) polyploidy and haploidy induction; (d) Mutagenesis. SECOND SCHEDULE (r. 5(3)) PART I CLASSIFICATION OF CONTAINMENT LEVEL Level 1 Activities with no or negligible risk of adverse effect on human health, the environment and biological diversity. Level 2 Activities with low risk of adverse effect on human health, the environment and biological diversity that can easily be eliminated using generally known procedures for which the level of containment and protective measures are laid down. Level 3 Activities with a moderate risk of such adverse effect on human health, the environment and biological diversity that can only be eliminated by especially demanding interventions for which the level of containment and protective measures are laid down. Level 4 Activities with high risk of adverse effect on human health, the environment and biological diversity for which the level of containment and protective measures are laid down. PART II (r.19) GENERAL REQUIREMENTS FOR GOOD CONTAINMENT MEASURES A: CHECKLIST FOR INSPECTION – ANIMAL UNITS Containment level Specification 1 2 3 4 1 Isolation of animal unit optional yes yes yes 2 Animal facilities separated by lockable doors optional yes yes yes 3 Animal facilities designed to facilitate decontamination (waterproof and easily washable material, cages etc.) optional optiona l yes yes 4 Floor and/or walls easily washable optional floor floor and walls floor and walls 5 Floor to wall, wall to ceiling and wall to wall junctions should be rounded for easy cleaning yes yes yes yes 6 All joints between door frames and wall should be sealed yes yes yes yes 7 Animal facilities have to be cleaned regulary. Sinks have to be disinfected regulary. no yes yes yes 8 Surfaces have to be disinfected after work no yes yes yes 9 Used cages have to be decontaminated yes yes yes yes 10 Material to be sterilised or incinerated as well as used cages have to be transported so that the environment is not contaminated yes yes yes yes 11 Hands have to be decontaminated and washed if there is the possibility of contamination and after handling animals and waste yes yes yes yes 12 Access to animal facilities is restricted yes yes yes yes 13 An animal unit shall haveinstalled devices to detect fires, ventilation and heating failures and the intrusion of unauthorised personnel yes yes yes yes 14 Where appropriate, an inspection window should be fitted in the door yes yes yes yes 15 Animal facilities have to be aerated appropriately yes yes yes yes 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 yes yes yes yes 17 Measures to control undesired species such as insects and rodents yes yes yes yes 18 Drains and any other services that enter through the walls or floor should prevent the ingress of rodents and insects yes yes yes yes 19 Accidents, bites and scratches caused by animals have to be reported to the project leader who makes a written report yes yes yes yes 20 Personnel has to be trained in the handling of the animals yes yes yes yes 21 There have to be written records about the transfer of foreign genes, about the breeding experiments and the disposal of animals yes yes yes yes 22 Transgenic animals have to be identified easily. The insert can serve as an additional marker yes yes yes yes 23 Food and tobacco has to be stored so that it cannot come in contact with transgenic animals yes yes yes yes 24 Protective clothing and shoes have to be worn. They have to be changed or cleaned when the facility is left. yes yes yes yes 25 Protective clothing has to be stored separated no yes yes yes 26 Rodentbarrier 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 yes yes yes yes 27 Animal species shall be housed in appropriate cages, runs, pens suitable for their requirements yes yes yes yes 28 No animals should be admitted other than for experimental purposes yes yes yes yes 29 Biohazard sign no yes yes yes 30 Doors have to be closed if infected animals are held. There must be a sign indicating the kind of work no yes yes yes 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 no yes yes yes 32 Use of safety cabinets where aerosols are released no yes yes yes 33 An autoclave should be available when genetically modified micro-organisms are used in experiments yes yes yes yes 34 In experiments where genetically modified micro-organisms are used contaminated material and waste should be inactivated yes yes yes yes 35 If genetically modified organisms can be transmitted, working tools and equipment have to be sterilised no yes yes yes 36 Waste contaminated with genetically modified organisms must only be transported in suitable containers no yes yes yes 37 Genetically modified organisms must only be transported in breakproofed and closed containers no yes yes yes 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 no yes yes yes 39 Hygiene plan no yes yes yes 40 The animal facility has to be entered via a lock equipped with two self closing doors, hand washing basin, disin-fection dispenser and shower no no yes yes 41 Acceptability of windows that open yes yes no no 42 Emergency power supply for safety relevant equipment such as ventilation system no no yes yes 43 Where mechanical ventilation is provided, the airflow should be inwards. Air should not be recirculated to any part of the building. no yes yes yes 44 The ventilation system should be designed to prevent accidental reverse flow and positive pressurisation in any part of the animal unit no no yes yes 45 In case of work with airborne pathogens negative pressure relative to the pressure of the immediate surroundings, extract air should be HEPA* filtered no no yes yes 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 no no yes yes 47 Animals infected with risk group 3 micro organisms 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. no no yes yes 48 Carcasses have to be sterilised prior to disposal. If this is not possible inside the facility, carcasses have to be trans-ported in closed, leakproofed and disinfected containers no no yes yes 49 Waste water has to be sterilised no no yes yes *High-efficiency particle arresting B: CHECKLIST FOR INSPECTIONS (CONTAINED USE – GLASSHOUSES AND GROWTH-ROOMS) Containment level Specification 1 2 3 4 1 Greenhouse: permanent structure No Yes Yes yes 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) No Optional Yes yes 3 Control of contaminated run-off water Optional Minimise run-off Prevent run off Prevent run-off 4 There must be a suitable program to control plant pests, weeds, insects and rodents Yes Yes Yes yes 5 Measures to control undesired species such as weed, insects, rodents, arthropods Yes Yes Yes yes 6 Procedures for transfer of living material between the glasshouse/growth-room, protective structure and laboratory shall control dissemination of genetically modified micro-organisms Minimise dissemination Minimise dissemination Prevent dissemination Prevent dissemination 7 Transport of GMOs in suitable closed non breakable container No Yes Yes yes 8 The container shall be decontaminated if organisms outside are present within the effective dissemination distance of the experimental organism, e.g. by fumigation No No Yes yes 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. Yes Yes Yes yes 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. No Yes Not applicable Not applicable 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 No Yes Not applicable Not applicable gravel 12 The ground of the greenhouse is made of water impermeable material with provisions to collect and sterilise wastewater. No No Yes yes 13 Escape of GMOs Minimised Prevent Prevent Prevent 14 Windows shall be closed and sealed No No With insect nets Yes Yes 15 All glazing shall be resistant to breakage No No Yes Yes 16 Biohazard sign at entry No Yes Yes Yes 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 No Optional Yes Yes 18 Access is limited to the project leader and personnel authorised by him No Yes Yes Yes 19 Protective clothing shall not be worn outside the greenhouse Yes Yes Yes Yes 20 Separate facilities for storing protective and street clothing shall be available No Yes Yes Yes 21 Protective clothing has to be sterilised before laundry No No Yes Yes 22 Gloves shall be worn at work No No Yes Yes 23 Injuries have to be reported immediately to the project leader Yes Yes Yes Yes 24 There must be written instructions for greenhouse practices and procedures Yes Yes Yes Yes 25 Hand disinfection apparatus and wash basin No Yes Yes Yes 26 Greenhouse to be entered via a lock with self-closing doors and hand disinfection No No Yes Yes apparatus and touch-free hand washing basin. 27 Air intake screening and motorised or gravity-driven exhaust fan louvers Yes Yes Not applicable Not applicable 28 The glasshouse has to be held under negative pressure compared to the surrounding No No Yes Yes 29 If there is the danger of the dissemination of airborne pathogens, exhaust air has to be filtered through HEPA-filters No No Yes Yes 30 Before disposal genetically modified plants have to be made unable to reproduce, e.g. by cutting off blossoms Yes Not applicable Not applicable Not applicable 31 Equipment which was in contact with GMOs has to be sterilised before cleaning, if the contact may lead to the transmission of GMOs No Yes Yes Yes 32 Autoclave inside the glasshouse No No, but available Yes Yes 33 The glasshouse has to be surrounded by a security fence or equal protection system No No Yes Yes C: CHECKLIST FOR INSPECTIONS (CONTAINED USE – LABORATORY ACTIVITIES) I. Physical Control Measures a) Facility design Containment level Specification 1 2 3 4 1. Process with viable micro-organisms separated from the environment (closed system) yes yes yes yes 2. Laboratory suite isolation no no yes yes 3. Restricted access to the facility (e.g. electronic cards, camera) no yes yes yes 4. laboratory sealable for fumigation no no yes yes 5. Acceptability of windows that open yes yes no no 6. Biohazard sign on the door no yes yes yes 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 no yes yes yes 8 Ventilation system no no yes yes b) Containment equipment Containment level Specification 1 2 3 4 1 Surfaces resistant to water, acids, alkalis, solvents, disinfectants, decontamination agents and easy to clean yes yes yes yes 2 Suitable of equipment used for safety purposes no yes yes yes 3 Suitable chemical disinfectants in use optional yes yes yes 4 suitable position of the autoclave with respect to the genetically modified organism installation on site in the building in suite in lab, double closed 5 Autoclave provides a print-out showing the temperature and time of sterilisation no no yes yes 6 Wash hand basin or sink that can be used for hand washing with: dispenser containing soap dispenser containing hand disinfectant paper towels yes yes yes yes 7 Appropriate position and design of biological safety hoods optional yes yes yes 8 Suitable design of the equipment for the safe storage of genetically modified organisms yes yes yes yes 9. suitable design of waste transport containers optional yes yes yes 10. Suitable design of containers for the transport of genetically modified organisms inside the facility optional yes yes yes 11. Suitable design of centrifuge buckets yes yes yes Yes 12. Entry to lab via airlock no no optional yes 13. Air lock with two doors which are interlocked no no yes yes 14. Air lock equipped with a hand washing basin (touch free) and hand disinfectant dispenser no no yes yes 15. Negative pressure relative to the pressure of the immediate surroundings no no optional yes 16. Ventilation system is alarmed to indicate a failure to generate a negative pressure no no yes yes 17. Ventilation system connected to an no no yes yes emergency power supply 18. Switch for ventilation system should be accessible from outside of the laboratory in case of fumigation no no yes yes 19. Extract and input air from the laboratory should be HEPA* filtered no no extract air input and extract air 20. Filters have to be sterilised on site or instantly sealed in a plastic bag for later sterilisation no yes yes yes 21. Alarm systems for workers working alone no no yes yes 22. Shower for the occupants before leaving the laboratory no no optional yes 23. An observation window or alternative is to be present so that occupants can be seen optional optional optional yes II. Safety Management a) Work procedures Containment level Specification 1 2 3 4 1 Engineering control measures have to be exercised at source and supplement these with appropriate personal protective clothing and equipment where necessary yes yes yes yes 2 Control measures and equipment have to be tested adequately and maintained es yes yes yes 3 Doors and windows closed while working only doors yes yes yes 4 Access to the laboratory must be restricted when experiments are in progress no yes yes yes 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 procedures b) the procecures for using particular pieces of equipment c) spillage control and other emergency procedures yes yes yes yes 6 Check at which process steps hazardous quantities of aerosols are formed optional yes yes yes 7 Prevention of aerosol formation yes yes yes yes 8 Genetically modified organisms are only to be transported within the facility in closed, robust and leakproof containers yes yes yes yes 9 Work surfaces must be decontaminated daily and after a spillage yes yes yes yes 10 Effective disinfectants and specified desinfection procedures in case of spillage of genetically modified organisms yes yes yes yes 11 Inactivation of genetically modified organisms in contaminated material and waste optional yes yes yes 12 Inactivation of genetically modified organisms in effluent from the hand washing sinks or drains and showers and similar effluents no no optional yes 13 Benches should be free from clutter yes yes yes yes 14 The identity of genetically modified organisms should be regulary checked to avoid the culturing of incorrect stains. (The time between these checks should be dependent upon the potential hazard). optional yes yes yes 15 Corrective actions following the results of the controls and way to register them yes yes yes yes 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 yes yes yes yes 17 Prohibition of mouth pipetting yes yes yes yes 18 Prohibition of eating, drinking, smoking, applying cosmetics or the storing of food for human consumption in the work area yes yes yes yes 19 Skin contact with rDNA material must be avoided yes yes yes yes 20 Hands must be washed after handling rDNA and before leaving the laboratory yes yes yes yes 21 Protective clothing yes yes yes and optional footwear yes, complete change of clothing & footwear 22 Decontaminate protective clothing before laundering yes yes yes yes 23 Protective clothing and street wear must be kept separate yes yes yes yes 24 Gloves no optional yes yes 25 Implementation of an insect and rodent optional yes yes yes control pro-gramme 26 Keep the workplace and environmental exposure to any physical, chemical or biological agent to the lowest practicable level yes yes yes yes 27 Tests, when necessary, for the presence of viable genetically modified organisms outside the primary physical containment yes yes yes yes 28 Use of sharps should be avoided yes yes yes yes 29 Contaminated syringes / sharps must be disposed of in a ‘Sharps bin’ and incinerated yes yes yes yes 30 where appropriate make vaccines available no yes yes yes 31 Establish Insitutional Biosafety Committees or sub-committees as required yes yes yes yes 32 Animals must not be allowed to enter into the laboratory yes yes yes yes 33 Where appropriate serum samples must be taken from workers and stored to provide baseline information in the event of an unexplained illness no optional optional optional 34 Sample collection, addition of materials to closed system and transfer of viable micro organisms to another closed system, should be performed appropriate yes yes yes yes 35 Safe storage of biological agents yes yes yes yes 36 Safe storage of contaminated laboratory equipment and materials, when appropriate yes yes yes yes Containment level Specification 1 2 3 4 1 Keep adequate records yes yes yes yes 2 Hygiene plan no yes yes yes 3 Provide written standard operating procedures where appropriate to ensure safety yes yes yes yes 4 Provide documentation of the appointment of the BioSafety Officer (BSO) yes yes yes yes 5 The appointment of project leader yes yes yes yes 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 yes yes yes yes 7 A description of the tasks of the project leader with respect to: yes yes yes yes 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 yes yes yes yes 9 The status of the BioSafety Officer should be defined yes yes yes yes 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 yes yes yes yes 11 Written instructions should be in both national languages yes yes yes yes 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 yes yes yes yes 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 yes yes yes yes 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 b) Institutional matters and documentation relating to the safe handling of genetically modified organisms NB: Risk assessment of the genetically modified organisms that will be handled in every facility will be evaulation during application to the Authority. III – Contingency Plan Containment level Specification 1 2 3 4 1 Check contigency plans for protection of the environment and the public outside of the facility no no optional yes 2 Check information on accidents (reporting of accidents and near – misses and records of corrective actions that have been taken) yes yes yes yes 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 counter-measures in case of accidents or incidents no yes yes yes THIRD SCHEDULE (r. 7 (3)) This Schedule comprises of application forms for contained use activities. The forms are as follows: 1. Laboratories , Green houses and Growth chambers 2. Confined field trials for Animals, animal health inputs and microorganisms 3. Confined field trials for plants. Part I APPLICATION FORM FOR CONTAINED USE ACTIVITY (LABORATORY, GREENHOUSE AND GROWTH CHAMBERS) GENERAL REQUIREMENTS FOR THE APPLICATIONS This application form must be completed for each individual genetically modified organism for the intended contained use activity. The application may include more than one experiment (genetic modification of that particular species) or protocols and all sections must be completed. Additional pages can be attached if the space provided is not sufficient. Applications for new and renewal of previously authorized contained use should be submitted separately. 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 2.0 Nature and purpose of contained use 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 3.0 Risk assessment 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. 0 Location where contained use activities are to be undertaken 4.1 Contained Use Facility: Laboratory and growth chambers 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 (Level1, 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 Contained Use Facility: Greenhouse Facility 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 (m2 /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 be 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 5.0. Nature and identity of Genetically modified organism 5.1 Name of GMO 5.2 Modified trait(s) Identification  Herbicide Tolerance  Modified Oil Composition  Pharmaceutical  Male sterility/restoration  Virus Resistance  Genetic Research  Insect Resistance  Stress Tolerance  Generation of mutants  Nutritional change  Fungal Resistance  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? 5.9.2 Is the vector disarmed? 5.9.3 If yes, how was the vector disarmed?  Yes  No  Yes  No 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 5.10.3 Source 5.10.4 Function (bp) 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. 6.0 Nature and purpose of the contained use activities 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 7.0 Containment measures 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 genetically modified organisms, and the plan of their refresher training 8.0 Declaration of correctness of information I certify that the above information is true to the best of my knowledge. Principal Investigator Name Signature Date Collaborator(s) Name(s) Signature Date Collaborator(s) Name(s) Signature Date Institutional Biosafety Committee (IBC) Review This application has been reviewed by IBC Name of IBC Name of chairperson Signature Date PART II APPLICATION FORM FOR CONTAINED USE AND CONFINED FIELD TRIALS ( GENETICALLY MODIFIED ANIMALS, ANIMAL HEALTH INPUTS AND MICRO ORGANISMS) This application form must be completed for each individual animal/organism species. Applications for new and renewal of previously authorized contained or confined research field trials should be submitted separately. Sections 1, 2 and 3 must be completed for all contained use (laboratory and animal units) trials. For all confined field trials, Section 4 must be completed, in addition to Sections 1, 2 and 3. Section 1: General Information 1.0 Title of Planned Introduction 1.1 Application Type 1.2 Animal/Organism Species Name 1.2.1 Latin Name(s)  New  Renewal 1.2.2 Common Name(s) 1.3 Feed Section Indicate 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 Applicant 1.4.1 Name 1.5 Co-Applicant - Complete if the applicant is not a Kenyan resident 1.5.1 Name 1.4.2 Address 1.5.2 Address (Affiliate Institution) 1.4.3 Telephone 1.4.4 Facsimile\ 1.5.3 1.5.4 Facsimile/Email Email Telephone 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 trial 1.8.2 What are the aims and objectives of the proposal? 1.8.3 What is the intended eventual use(s) of the products? Description of the Unmodified Animal/Organism 1.9 Fertility 1.9.1 Describe mechanisms and frequency of intra-and inter-specific out-crossing. 1.9.2 Describe the mechanism of infertility 1.10 Habitat 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 Phenotypic Characteristics Provide information on animal/organism mechanisms responsible for: 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 Toxins 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 Allergens 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 Section 2: Submission Please fill out Section 2 for each individual Submission included in the application. 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 xenotransplantatio n.  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 which are environmentally friendly e.g. improved use of dietary phosphorous to lessen the environmental impacts of animal manure.  In the phylogenetic analysis of the amplified 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 History Has 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 Trait Introduction and Selection Method 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 Other Provide details of modification by means other than mutagenesis or recombinant techniques. 2.7 Gene Donor Indicate the gene’s donor organism (for animals or organisms transformed using recombinant techniques). 2.8 Transformation Plasmids Please provide the following information: 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 as appropriate) 2.8.3 Is the vector disarmed? (Tick as appropriate) 2.8.4 If yes, how was the vector disarmed?  Yes  No  Yes  No 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 Characteristics of the Novel Trait(s) 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? 2.9.1.3Is the trait inducible? If yes, how? 2.10 Toxicity and Allergenicity of the Novel Trait(s) 2.10.1 To what extent are novel gene products toxic when ingested by native faunal 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 Altered Animal or Organism Characteristics Please indicate any changes with respect to the following: 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 Facility Inspection 2.12.1 Has the facility been inspected by the relevant regulatory agency?  Yes  No Please attach the facility inspection approval letter/certificate 2.13 Trial Site Locations and Trial Protocols Town and Province Legal land and location Trial Protocol(s) – Attach trial Protocol Please note: Section 3 must be completed for each Trial Protocol listed above and, for confined field trials. Section 4 must be completed for each Trial Site Location listed above. Section 3: Contained Use Trial Protocol Please fill out Section 4 for each Trial Protocol included in the application. 3.1 Trial Protocol (Study) Title: 3.2 Protocol Describe fully the purpose of the trial, the experimental design, the nature and type of data to be collected and arrangements for transporting the GMO to the trial site. Please include proposed, if any, herbicide/pesticide use. 3.3 Provide work schedule (post approval) to include: 3.3.1 Intervention (anticipated) 3.3.2 Sampling (anticipated) 3.4 Isolation State 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 Act. 3.6.4 Unregistered Pesticide Use Indicate whether the trial site location will be subject to unregistered pesticide use. Yes No   3.7 Harvesting 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 mater—ial. 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 Disposal Plan 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 Contingency Plans 3.9.1 Describe your contingency plan in the case of accidental release of GMO material or the breakdown of isolation/quarantine. 3.10 Monitoring the Trial Site 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 be 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. Section 4: Field Trial Site Location (To be completed for confined field trials only) Please fill out Section 3 for each Trial Site Location included in the application. 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) 4.4.1 Name 4.5 Trial Size Trial size in meters2 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 Habitat 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 ecosystem? Yes No   4.7.4 How close is the site from an area of special ecological interest, including protected areas and sanctuaries? 4.8 Indigenous Species 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 Post-Trial Land Use 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. 4.10 Submissions and Trial Protocols Please list all submissions and trial protocols used at this site. Submission (Animal or organism novel trait designation – List of possible designations/unique identifier) Trial Protocol(s) Please note: Section 2 must be completed for each Submission listed above and Section 4 must be completed for each Trial Protocol listed above. 4.11 Public Notice 4.11.1 How will you provide public notification of your proposed field trial? Section 5: Certification I certify that the above information is true to the best of my knowledge. Principal Investigator Name Signature Date Collaborator(s) Name(s) Signature Date Collaborator(s) Name(s) Signature Date Collaborator(s) Name(s) Signature Date Institutional Biosafety Committee (IBC) Review This application has been reviewed by IBC Name of IBC Name of chairperson Signature Date PART III APPLICATION FORM FOR CONFINED FIELD TRIAL (PLANTS) This application form must be completed for each individual genetically modified plant. The application may include more than one submission of a genetic modification of that particular species, Trial site Location and/or Trial Protocol. Complete section 2 for each submission, section 3 for each trial site and section 4 for each trial protocol included in the application. All sections must be completed. Additional pages can be attached if the space provided is not sufficient. Applications for new and renewal of previously authorized confined research field trials should be submitted separately. Section 1.0 General Information 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 Section Indicate whether any plant material generated in the confined field trials will be used as research material for livestock feed. Yes No   1.4 Applicant 1.4.1 Name 1.5 Name of Institutional Biosafety Committee. (Attach signed minutes of Institutional Biosafety Committee discussions) 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 Telephone 1.4.4 Facsimile/email 1.5.3 Telephone 1.5.4 Facsimile/email 1.6 Summary of trial 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 Description of unmodified plant species 1.7.1 Describe mechanisms and frequency of intra-and inter-specific out-crossing. 1.7.2 Describe the mechanism of infertility 1.8 Phenotypic Characteristics Provide information on plant mechanisms responsible for: 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 Toxins 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 Allergens 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 the genetically modified organism but not to the unmodified plant. Section 2: Submission 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  Modified Oil Composition  Pharmaceutical  Male sterility/restoration  Virus Resistance  Genetic Research  Insect Resistance  Stress Tolerance  Generation of mutants  Nutritional change  Fungal Resistance  Other (Specify) 2.3 Modified Trait(s) Describe each specific novel trait associated with this genetically modified organism. 2.4 Status of authorization 2.4.1 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 History Has this Genetically Modified Organism been previously tested in Kenya?  Yes  No If yes, please provide information on trial (s), year(s) of authorization and location(s) tested. 2.6 Trait Introduction and Selection Method 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 modification Provide details of modification by means other than mutagenesis or recombinant DNA techniques. 2.7 Gene Donor (s) Indicate the gene donor organism(s) (for plants transformed using rDNA techniques). 2.8 Transformation Vectors and/or Plasmids Please provide the following information: 2.8.1 Name of plasmid (construct) and genetic map (map of each genetic construct required). 2.8.2 Is the vector naturally 2.8.3 Is the vector 2.8.4 If yes, how was the vector pathogenic? disarmed? disarmed?  Yes  No  Yes  No 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 Characteristics of the transformed Trait(s) 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?  Yes  No If yes, when? 2.9.1.3 Is the trait inducible?  Yes  No If yes, how? 2.10 Toxicity and Allergenicity of the Transformed Trait(s) 2.10.1 To what extent are transformed gene products toxic when ingested by native fauna populations, including mammals, birds, reptiles, and insects? 2.10.1.1How 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 Altered Plant Characteristics Please indicate any changes with respect to the following: 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 the species? 2.11.9 Please describe if any toxins and allergens are produced by the GMO that were not produced 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 Trial Site Locations and Trial Protocols 2.12.1 Town and Province 2.12.2 Legal land location 2.12.3 Trial Protocol(s) (Attach trial Protocol) Please note: Section 3 must be completed for each Trial Site Location listed above and Section 4 must be completed for each Trial Protocol listed above. Section 3: Confined Field Trial Site Please fill out Section 3 for each Trial Site Location included in the application. 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 site 3.4.1 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 Size Trial 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. Explain 3.7 Habitat 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 Indigenous Species 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 Post-Trial Land Use 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 Submissions and Trial Protocols Please list all submissions and trial protocols used at this site. 3.10.1 Submission (genetically modified organism designation – List of possible designations/unique identifier) 3.10.2 Trial Protocol(s) Please note: Section 2 must be completed for each Submission listed above and Section 4 must be completed for each Trial Protocol listed above. Section 4: Confined Field Trial Protocol Please fill out Section 4 for each Trial Protocol included in the application. 4.1 Trial Protocol (Study) Title: 4.2 Protocol 4.2.1 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 Provide work schedule (post approval) to include: 4.3.1 Planting (anticipated) 4.3.2 Harvest/Sampling (anticipated) 4.4 Isolation State 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 Seeding 4.5.1 Material will be 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  Or 4.5.1.2Mechanically  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/GMO will be disposed of or stored. 4.6 Spraying* 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. 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 Harvesting 4.7.1 Will plants be allowed to set seed or to reproduce? 4.7.2 Describe the method of harvest for seed and other plant material (e.g. by hand, small plot combine, etc.) Yes  No  4.7.3 Will any harvested plant material be retained from the trial? 4.7.4 Material retention If yes Yes  No  4.7.4.1 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 Disposal 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 Contingency Plans 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 Monitoring the Trial Site 4.10.1 Describe the extent and frequency of trial site monitoring during the course of the field trial. 4.10.2 Describe the extent and frequency of trial site monitoring during the post-trial period. 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 GMO 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 Public Notice 4.11.1 How will you provide public notification of your proposed field trial? Section 5: Hectarage Please indicate the number of hectares per submission per province (Limit of 5 ha cumulative per submission per province) Province A: Submission (genetically modified organism designation): Trial site location Legal land location Town Number of hectares Total number of hectares: Province B: Submission (Genetically modified organism designation): Trial site location Legal land location Town Number of hectares Total number of hectares: Add other tables for any other Province, if applicable Section 6: Certification I certify that the above information is true to the best of my knowledge. Principal Investigator Name Signature Date Collaborator(s) Name(s) Signature Date Institutional Biosafety Committee (IBC) Review This application has been reviewed by IBC Name of IBC Name of chairperson Signature Date FOURTH SCHEDULE (r. 9) THE NATIONAL BIOSAFETY AUTHORITY APPROVAL TO CONDUCT CONTAINED USE ACTIVITY USING GENETICALLY MODIFIED ORGANISM APPROVAL NUMBER DATE OF ISSUE VALID UP TO 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: Date Name: Signature: The Chief Executive Officer National Biosafety Authority FIFTH SCHEDULE (r 13, 14) CONTINGENCY PLAN 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 DECLARATION BY APPLICANT I, ………………………… of P.O. Box No. …………… of (Company/ Institution) …………. ……. ID No. ……………., hereby declare that to the best of my knowledge and belief the particulars given in this application are true and correct. Declared by } this day of } DECLARANT at } Before me Commissioner for Oaths/Magistrate/Judge Dated this 15th July, 2011. HELLEN SAMBILI, Acting Minister for Higher Education, Science and Technology.