ADVOKS GLOBAL · KENYA
Kenyan legislation
The Biosafety (Contained Use) Regulations
Edition: 2022-12-31 · In force
Browse sections
Part I – PRELIMINARY
1. Citation
These Regulations may be cited as the Biosafety (Contained Use) Regulations.2. Interpretation
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 Cabinet Secretary 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.3. Objective
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.4. Exceptions
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 (sub. leg).Part II – CONTAINMENT MEASURES
5. Classification of containment levels
(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.6. Institutional Biosafety Committee
(1)A research institution undertaking contained use activities shall establish an Institutional Biosafety Committee.(2)An Institutional Biosafety Committee shall consist of—(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.7. Application for contained use
(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 subregulation (1) commits an offence.8. Consideration of application
(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.9. Approval
(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.10. Validity of the approved activity
(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.11. Suspension or revocation of approval
(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.12. Handling of new information
(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.13. Contingency plans
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.14. Contents of contingency plans
Every contingency plan shall be in the form set out in the Fifth Schedule.15. Emergency measures
(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 subregulation (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 subregulation (1) commits an offence.Part III – MISCELLANEOUS
16. Information sharing and records
(1)The Authority shall maintain a register which shall contain—(a)a copy of the—(ii)risk assessment document;(iv)approval document; and(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.17. Registration of decisions in the National Biosafety Clearing House
The Authority shall register all decisions made under these Regulations in the National Biosafety Clearing House within thirty days of making the decision.18. Confidential information
(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.19. Good containment measures
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.20. Handling of modified plasmids and vectors
Modified plasmids or vectors used as tools for modern biotechnology shall be approved by the relevant regulatory agency.21. Penalties
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.