The Biosafety (Import, Export and Transit) Regulations

Section 1. Citation Section These Regulations may be cited as the Biosafety (Import, Export and Transit) Regulations.

Section 2. Interpretation Section In these Regulations unless the context otherwise requires— "accident" means the unintended release of genetically modified organisms in the course of import, export or transit, which could pose present an immediate or delayed hazard to human health and the environment; "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; "competent authority" means an agency of another country responsible under its national law for the control or regulation of genetically modified organisms; "contained use" means any activity undertaken within a facility, field, installation or other physical structure, which involves genetically modified organisms that are controlled by specific measures to provide safety for humans and the environment; "contained use premises" includes a facility, field, installation or other physical structure in which contained use is undertaken; "environmental release" means introduction into the environment of a genetica...

Section 3. Objective Section The objective of these Regulations is to ensure safe movement of genetically modified organisms into and out of Kenya while protecting human health and the environment.

Section 4. Application and requirements for import Section 4(1) A person wishing to import a genetically modified organism shall apply for and obtain written approval from the Authority. Section 4(2)(a) a cover letter; and Section 4(2)(b) an application fee of twenty five thousand shillings. Section 4(3)(a) the species or identity and amount of the genetically modified organism proposed to be imported; and Section 4(3)(b) the proposed port of entry into Kenya; Section 4(3)(c) the intended purpose for the genetically modified organism: Section 4(3)(i) where the intended purpose is for contained use the provisions of the Biosafety (Contained Use) Regulations (sub. leg) shall apply; Section 4(3)(ii) where the intended purpose is for the environmental release the provisions of the Biosafety (Environmental Release) Regulations (sub. leg) shall apply. Section 4(4) The Authority may opt not to undertake risk assessment in cases where it previously gave approval for importation of the same genetically modified organisms from the same source. Section 4(5) A person who contravenes subregulation (1) of this regulation commits an offence.

Section 5. Unauthorized importation Section shall initiate remedial action such as refusal of entry, destruction or set conditions of use; and

Section 6. Application and requirements for export Section 6(1) A person wishing to export a genetically modified organism shall apply for and obtain written approval from the Authority. Section 6(2)(a) consent or approval for import issued by the competent authority of the importing country; and Section 6(2)(b) an application fee of twenty five thousand shillings. Section 6(3)(a) the species or identity and amount of the genetically modified organism that is to be exported; and Section 6(3)(b) the proposed port of exit from Kenya. Section 6(4) The Authority shall, upon receipt of an application under this regulation, confirm that the proposed export meets the requirements of the importing country and may issue the approval in the manner prescribed in the Second Schedule. Section 6(5) The Authority shall give a copy of the approval to the relevant regulatory agency for authorization of export. Section 6(6) A person who contravenes subregulation (1) of this regulation commits an offence.

Section 7. Application and requirements for transit Section 7(1) A person wishing to transit a genetically modified organism shall apply for and obtain written approval from the Authority. Section 7(2) An application under subregulation (1) shall be in the form set out in the First Schedule. Section 7(3) A person transiting a genetically modified organism shall ensure that the genetically modified organisms are packaged and transported in accordance with Kenyan and International standards. Section 7(4) A person who contravenes subregulation (1) commits an offence.

Section 8. Conditions for transit Section 8(1) A person transiting a genetically modified organism shall provide a copy of the approval granted by the Authority at the port of entry and exit. Section 8(2)(a) approved methods for packaging and handling of genetically modified organisms imported through conveyor shipment which should comply with the relevant international and national requirements for repackaging and handling of conveyor shipped commodities; Section 8(2)(b) a requirement that conveyor shipment shall meet import conditions under these Regulations; and Section 8(2)(c) a copy of the import permit issued by the receiving country indicating the quantities or volumes involved from the country of origin and confirming that the consignment may contain genetically modified materials. Section 8(3) The Authority shall liaise with the relevant regulatory agency to ascertain that the consignment at the port of entry and exit is consistent with accompanying documents.

Section 9. Unauthorized transit Section confisticate the genetically modified organism;

Section 10. Unintentional release while on transit Section 10(1)(a) notify the Authority immediately both verbally and in writing of the accident; and Section 10(1)(b) the circumstances of the accident; Section 10(1)(b)(i) the circumstances of the accident; Section 10(1)(b)(ii) the identity and the quantity of genetically modified organism released; Section 10(1)(b)(iii) the type of accident; and Section 10(1)(b)(iv) any emergency measures taken or that ought to be taken to avoid or mitigate any adverse effects of the accident; Section 10(1)(c) take all appropriate short term, medium term and long term measures to avoid or mitigate any adverse effects of the accident. Section 10(2) The Authority shall inform and advise the public of the accident. Section 10(3) The Authority in consultation with the relevant regulatory agency shall undertake necessary action to minimize risk to human health and environment.

Section 11. Approval Section An approval granted by the Authority under these Regulation shall be in the form set out in the Second Schedule to these Regulations.

Section 12. Monitoring for compliance Section The Authority shall liaise with the relevant regulatory agency to monitor any imported genetically modified organisms for compliance with the requirements of these Regulations.

Section 13. Genetically modified organisms register Section The Authority shall maintain a register, which shall contain all applications made to and decisions made by the Authority regarding genetically modified organisms.

Section 14. Review of decisions Section a change in circumstances has occurred which may influence the approval or the conditions issued under the approval; or

Section 15. Registration of decisions in the National Biosafety Clearing House Section The Authority shall register all decisions made under these Regulations in the National Biosafety Clearing House within thirty days of making the decision.

Section 16. Confidential information Section 16(1) The Authority shall not disclose to a third party any confidential information exchanged under these Regulation and shall protect the intellectual property rights of the applicant. Section 16(2) The applicant may indicate, with verifiable justification, information in the application the disclosure of which might harm the competitive position of the applicant and which should be kept confidential. Section 16(3)(a) the name and address of the exporter and importer; Section 16(3)(b) the unique identifier of the genetically modified organism; Section 16(3)(c) a summary of the risk assessment; and Section 16(3)(d) any method and plans for emergency response. Section 16(4) Where an applicant withdraws an application, the authority shall respect the confidentiality of the information supplied.

Section 17. Products derived from genetically modified organisms Section 17(1) A person intending to export, import or transit a product derived from genetically modified organisms whose safety has been established in accordance with Kenya Standards for food and feed safety assessment shall notify the Authority in writing indicating proof of safety. Section 17(2) The information required under subregulation (1) shall be provided in the format prescribed in the Third Schedule. Section 17(3) Upon receipt of such notification, the Authority shall, in consultation with the relevant regulatory agency, review the information provided and communicate its decision.

Section 18. Offences and penalties Section A person who contravenes 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.