The Biosafety (Environmental Release) Regulations

Section 1. Citation Section These Regulations may be cited as the Biosafety (Environmental Release) Regulations.

Section 2. Interpretation Section for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment; and

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 environmental release.

Section 4. Exceptions Section These Regulations shall not apply to genetically modified organisms that are pharmaceuticals for human use.

Section 5. Environmental release Section 5(1) A person shall not make an environmental release without the written approval of the Authority. Section 5(2)(a) an application fee of Kenya shillings eight hundred and fifty thousand; and Section 5(2)(b) where necessary, an additional risk assessment report. Section 5(3)(a) refer to data or results from an application previously submitted by another applicant; or Section 5(3)(b) submit additional information that the applicant considers relevant, provided that the information, data and results are non-confidential or such applicants have given their agreement in writing. Section 5(4) The Authority may allow an application for release of the same genetically modified organism on the same site or on different sites for the same purpose and within a definite period to be made in a single application. Section 5(5) Where the Authority, after a risk assessment, considers that it is necessary for the genetically modified organism to be subjected to contained use, the Authority shall communicate its decision to the applicant in writing and the provisions of the Contained Use Regulations shall apply. Section 5(6) Where the application is for int...

Section 6. Placing on the market Section 6(1) A person shall not place on the market a genetically modified organism without the written approval of the Authority. Section 6(2)(a) an application fee of Kenya shillings eight hundred and fifty thousand; and Section 6(2)(b) where necessary, a risk assessment report. Section 6(3)(a) refer to data or results from an application previously submitted by other applicants; or Section 6(3)(b) submit additional information that the applicant considers relevant, provided that the information, data and results are non-confidential or such applicants have given their agreement in writing. Section 6(4) A person who contravenes subregulation (1) commits an offence.

Section 7. Consideration of an application Section 7(1) Upon receiving an application, the Authority shall within fourteen days screen for completeness and circulate to the relevant regulatory agencies for further information, comments or reasoned objections. Section 7(2)(a) the conformity of an application with the requirements of these Regulations; Section 7(2)(b) the accuracy and completeness of the information given; Section 7(2)(c) the risk assessment submitted by the applicant; and Section 7(2)(d) the uses of the genetically modified organism. Section 7(3) The authority shall publicize an application received hereunder and invite written comments from members of the public within twenty one days. Section 7(4) Where necessary, the Authority may ask an applicant to provide further information. Section 7(5) The Authority shall communicate its final decision to the applicant within one hundred and fifty days of receipt of the application, but not earlier than ninety days of such receipt. Section 7(6) For the purpose of calculating the periods, any period of time during which the Authority is awaiting any further information that it may have requested from the applicant shall not...

Section 8. Non-assessment of risks Section 8(1) The Authority may opt not to undertake risk assessment where it determines that sufficient experience or information exists to conclude that an environmental release does not pose a significant risk. Section 8(2) Once an approval has been granted by the Authority for release of a genetically modified organism, subsequent release of the same species, or the same species modified with the same gene or combination of genes, may be exempted from risk assessment.

Section 9. Approval Section 9(1) An approval for environmental release shall be in the Form set out in the Second schedule to these Regulations. Section 9(2) If information becomes available that an approved activity poses a risk to human health or the environment, the Authority may amend or revoke the approval.

Section 10. Validity and renewal of approval Section 10(1) An approval granted under these Regulations shall be for a period not exceeding ten years. Section 10(2) At least nine months before the expiry of an approval period, a person intending to continue to release into the environment or placing genetically modified organisms on the market shall submit an application for the renewal of the approval. Section 10(3)(a) an application fee of eight hundred and fifty thousand shillings; Section 10(3)(b) a copy of the approval under regulation 9(1); Section 10(3)(c) a report on the results of the monitoring which was carried out in accordance with these Regulations; Section 10(3)(d) any new information which has become available with regard to the risks of the genetically modified organism to human health and the environment; and Section 10(3)(e) a proposal for amending or complementing the conditions of the original approval and any other conditions concerning future monitoring. Section 10(4)(a) approve the application with or without conditions; or Section 10(4)(b) reject the application stating the reasons for rejection. Section 10(5) Pending the renewal of an approval, an applicant...

Section 11. Handling of new information Section 11(1)(a) take the measures necessary to protect human health and the environment; Section 11(1)(b) inform the Authority in advance of any change or as soon as the unintended change is known or the new information is available; and Section 11(1)(c) revise the measures specified in the application or approval. Section 11(2)(a) shall evaluate such information and may make it available to the public; and Section 11(2)(b) may require the applicant to, modify the conditions of, suspend or terminate the environmental release.

Section 12. Public awareness and participation Section 12(1) The Authority shall promote public awareness and participation on the proposed environmental release. Section 12(2) In carrying out public awareness and participation, the Authority shall publish guidance documents. Section 12(3)(a) by notice in the Gazette; Section 12(3)(b) in at least two newspapers of wide circulation; and Section 12(3)(c) on its website, make available to the public, non-confidential information on applications for environmental release of genetically modified organisms. Section 12(4) Any person may within thirty days of the publication of a notice under paragraph (3), submit written comments on the proposed decisions for any application for placing a genetically modified organism on the market.

Section 13. Decision document Section 13(1) A decision on the application shall be recorded in a decision document. Section 13(2)(a) identification of properties of a recipient which are important for the use of the genetically modified organism; Section 13(2)(b) any known risks to health and the environment arising from the introduction of non-modified recipient into the environment or on the market; Section 13(2)(c) description of results of genetic modification in genetically modified organisms; Section 13(2)(d) evaluation of the sufficiency of characterising genetic modification in the request to assess risks; Section 13(2)(e) identification of risks to the health of humans, animals, plants and the environment which may arise from the use of genetically modified organisms in comparison with the use of corresponding non-modified organism, based on the risk assessment conducted; Section 13(2)(f) a genetically modified organism may be released into the environment or placed on the market, and under which conditions; or Section 13(2)(f)(i) a genetically modified organism may be released into the environment or placed on the market, and under which conditions; or Section 13(2)(f)(ii...

Section 14. Monitoring Section 14(1) A person granted an approval under these Regulations together with the relevant regulatory agency shall monitor and report on the release in accordance with the approval. Section 14(2) The relevant regulatory agency shall submit the monitoring report to the Authority. Section 14(3) The Authority shall ensure that all appropriate measures are taken to avoid adverse effects on the health of humans, animals and the environment which might arise from the environmental release or the placing on the market of genetically modified organisms. Section 14(4) The Authority shall develop and issue an inspection manual and guidelines to ensure that the relevant regulatory agency organises inspections and other control measures as appropriate for purposes of compliance with this regulation. Section 14(5)(a) necessary measures are taken to terminate the release or placing on the market of such organism; Section 14(5)(b) remedial action is taken, if necessary; and Section 14(5)(c) the public is informed and appropriately advised on such release or placing on the market.

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. Confidentiality Section 16(1) The Authority shall not disclose to a third party any confidential information exchanged under these Regulations and shall protect intellectual property rights of the applicant. Section 16(2) An applicant may indicate with verifiable justification, information in the application submitted under these Regulations, the disclosure of which might harm the applicant’s competitive position and which should be treated as confidential. Section 16(3) The Authority shall, after consultation with the applicant, decide which information may be kept confidential and shall inform the applicant accordingly. Section 16(4)(a) the name and address of the applicant; Section 16(4)(b) the general description of the genetically modified organism; Section 16(4)(c) the purpose of the release; Section 16(4)(d) the location of release and intended uses; Section 16(4)(e) the plans for monitoring of the genetically modified organism and for emergency response; and Section 16(4)(f) the risk assessment report. Section 16(5) If, an applicant withdraws an application, the Authority shall respect the confidentiality of the information supplied.

Section 17. Offences and penalties Section A person who contravenes any of these Regulations commits an offence and shall be liable on conviction to a fine not exceeding twenty million shillings or to imprisonment for a term not exceeding ten years, or both.