The Biosafety (Contained Use) Regulations

Section 1. Citation Section These Regulations may be cited as the Biosafety (Contained Use) Regulations.

Section 2. Interpretation Section in-vitro nucleic acid techniques including the use of recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles; or

Section 3. Objective Section 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.

Section 4. Exceptions Section to genetically modified organisms which are pharmaceuticals for human use;

Section 5. Classification of containment levels Section 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. Section 5(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. Section 5(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. Section 5(4) The containment levels under this Regulation apply to laboratory, greenhouse or screen house activities. Section 5(5) Appropriate measures for confined field trials shall be determined through procedures developed by the Authority in consultation with the relevant Regulatory Agency.

Section 6. Institutional Biosafety Committee Section 6(1) A research institution undertaking contained use activities shall establish an Institutional Biosafety Committee. Section 6(2)(a) biosafety officer(s); Section 6(2)(b) scientist(s) in the relevant field; Section 6(2)(c) representative(s) of technical staff; Section 6(2)(d) representative(s) of laboratory management; Section 6(2)(e) representative(s) of the community where the premises are situated; and Section 6(2)(f) representative(s) of the relevant regulatory agency. Section 6(3)(a) to prepare applications for contained use activities and refer the applications to the Authority for approval; Section 6(3)(b) to advise the research institution on matters relating to biosafety; Section 6(3)(c) to assist the institution in the establishment of the appropriate monitoring mechanisms for risk assessments and risk management; Section 6(3)(d) to ensure compliance with the conditions set out in the approval; Section 6(3)(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;...

Section 7. Application for contained use Section 7(1) A person shall not undertake contained use without the written approval of the Authority. Section 7(2) An application for contained use shall be made to the Authority through an Institutional Biosafety Committee. Section 7(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. Section 7(4) A person who contravenes subregulation (1) commits an offence.

Section 8. Consideration of application Section 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. Section 8(2)(a) that the application conforms with the requirements of these Regulations; Section 8(2)(b) the accuracy and completeness of the information given; Section 8(2)(c) the risk assessment submitted by the applicant; Section 8(2)(d) the level of contained uses; and Section 8(2)(e) where appropriate, the suitability of the containment and other protective measures, the waste management, and contingency measures. Section 8(3)(a) require the applicant to provide further information; or Section 8(3)(b) require the applicant to modify the conditions of the proposed contained use, or to amend the level assigned to the contained use; or Section 8(3)(c) limit the time for which the contained use should be permitted or subject it to certain specific conditions. Section 8(4) The Authority shall communicate its final decision within one hundred and fifty days of receipt of the application but not earlier than ninety...

Section 9. Approval Section 9(1) An approval for contained use shall be in the form set out in the Fourth Schedule. Section 9(2) An approval granted under these Regulations shall be valid for the period of the activity in respect of which it is granted. Section 9(3) An approval for contained use is not transferable.

Section 10. Validity of the approved activity Section 10(1) An approval under these Regulations shall be for the period of the activity. Section 10(2) A grantee under these Regulations shall submit quarterly reports on the progress of the activity during the period of the approved activity.

Section 11. Suspension or revocation of approval Section 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. Section 11(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.

Section 12. Handling of new information Section 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. Section 12(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. Section 12(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. Section 12(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. Section 12(5)(a) does not require risk assessment, the Authority shall communicate its decision...

Section 13. Contingency plans Section 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;

Section 14. Contents of contingency plans Section Every contingency plan shall be in the form set out in the Fifth Schedule.

Section 15. Emergency measures Section 15(1)(a) the circumstances and location of the accident; Section 15(1)(b) the identity and quantities of the genetically modified organisms; Section 15(1)(c) any information necessary to assess the effects of the accident on human beings, and the environment; and Section 15(1)(d) the measures taken to mitigate against risk. Section 15(2)(a) ensure that necessary measures are taken to control the effects of the accident; Section 15(2)(b) where possible, collect, information necessary for a full analysis of the accident; and Section 15(2)(c) where appropriate, make recommendations on how to avoid a similar accident in the future and to limit the effects thereof. Section 15(3) A person who contravenes subregulation (1) commits an offence.

Section 16. Information sharing and records Section 16(1)(a) application; Section 16(1)(a)(i) application; Section 16(1)(a)(ii) risk assessment document; Section 16(1)(a)(iii) decision document; Section 16(1)(a)(iv) approval document; and Section 16(1)(a)(v) contingency plan; Section 16(1)(b) a list of institutional biosafety committees; and Section 16(1)(c) any other information that the Authority may deem necessary. Section 16(2) The register shall be open for inspection by any interested person upon payment of an inspection fee of five hundred shillings. Section 16(3) The Authority shall establish a procedure for the exchange of information and experiences gained.

Section 17. 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 18. Confidential information Section 18(1) An applicant may request that certain information in his application be treated as confidential and shall give reasons for the request. Section 18(2) The Authority shall determine if the information should be kept confidential and shall communicate its decision to the applicant in writing. Section 18(3)(a) name and address of the applicant; Section 18(3)(b) the general characteristics of the genetically modified organism; Section 18(3)(c) class of contained use and measures of containment; and Section 18(3)(d) the evaluation of foreseeable effects, in particular any harmful effects on human health and the environment. Section 18(4) The authority shall protect the intellectual property rights of the applicant. Section 18(5) Where an applicant withdraws an application, the Authority shall maintain confidentiality on the information supplied.

Section 19. Good containment measures Section 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.

Section 20. Handling of modified plasmids and vectors Section Modified plasmids or vectors used as tools for modern biotechnology shall be approved by the relevant regulatory agency.

Section 21. Penalties Section 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.