Kenya Act or statute

Parliament of Kenya

Biosafety Act

Jurisdiction: Kenya
Structure: 54 provisions
Citation: Cap. 320
Dates: As at 11 Dec 2023

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Dates: As at 11 Dec 2023

Source attribution: Source: Kenya Law

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Purpose and legislative effect

“This Act may be cited as the Biosafety Act.”

This Act may be cited as the Biosafety Act. This section defines key terms used in the Act, including "applicant", "Authority", "biosafety", "contained use", "environment", "financial year", "genetically modified organism", "intentional introduction into the environment", "Cabinet Secretary", "modern biotechnology", "placing on the market", and "regulatory agency". The Act does not apply to genetically modified organisms that are pharmaceuticals for human use. Facilitate responsible research into genetically modified organisms and minimize the risks they may pose. The Board has the power to delegate its powers, functions or duties to committees, officers, staff members or agents by resolution.

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PRELIMINARY - 1. Short title

This Act may be cited as the Biosafety Act.

Section 1

ESTABLISHMENT, POWERS AND FUNCTIONS OF THE AUTHORITY - 6. Board of theAuthority

Section 6 sets out the Board composition, appointment powers of the Cabinet Secretary for certain members, attendance permissions for specified members, a deeming rule for existing members upon reconstitution, and term length of three years with possible…

Section 6

APPLICATIONS FOR APPROVAL AND RISK ASSESSMENT - 28. Non-assessment of risks

The National Biosafety Authority may decide not to carry out a risk assessment for sections 18, 19 and 20 when it determines existing experience or information shows the GMO or contained use activity does not pose a significant risk.

Section 28

MISCELLANEOUS - 53. Restriction on institution of proceedings

No proceedings for an offence under this Act may be instituted without the prior written consent of the Director of Public Prosecutions.

Section 53

FINANCIAL PROVISIONS - 49. Investment of funds

Allows the Board to invest trust funds in securities and allows the Treasury to approve other securities for investment.

Section 49

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Showing 54 of 54 provisions

Provision 46Offence 3Commencement 2Short title

Part I

PRELIMINARY

§ 1PRELIMINARY - 1. Short titleShort title

This Act may be cited as the Biosafety Act.

Section 1. Short title Section This Act may be cited as the Biosafety Act.

Section 1Verify source

§ 2PRELIMINARY - 2. InterpretationInterpretation

This section defines key terms used in the Act, including "applicant", "Authority", "biosafety", "contained use", "environment", "financial year", "genetically modified organism", "intentional introduction into the environment", "Cabinet Secretary", "modern biotechnology", "placing on the market", and "regulatory agency".

Section 2. Interpretation Section In this Act, unless the context otherwise requires— "applicant" means a person submitting an application pursuant to the provisions of this Act; "Authority" means the National Biosafety Authority established under section 5 ; "biosafety" means the avoidance of risk to human health and safety, and the conservation of the environment ("the physical factors of the surroundings of human beings, including land, water, atmosphere, soil, vegetation, climate, sound, odour, aesthetics, fish and wildlife;") , as a result of the use of genetically modified organisms; "contained use" means any activity undertaken within a facility, installation or other physical structure which involves genetically modified organisms that are controlled by specific measures; "environment" includes the physical factors of the surroundings of human beings, including land, water, atmosphere, soil, vegetation, climate, sound, odour, aesthetics, fish and wildlife; "financial year" means the period of twelve months ending on the thirtieth June in each year; "genetically modified organism" means any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques; "intentional introduction into the environment" means any deliberate use of genetically modified organisms other than not contained use ("any activity undertaken within a facility, installation or other physical structure which involves genetically modified organisms that are controlled by specific measures;") ; "Cabinet Secretary" means the Cabinet Secretary for the time being responsible for matters relating to science and technology. "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 recombination barriers and which are not techniques used in traditional breeding and selection; "placing on the market" means making a genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") available for sale; and "regulatory agency" means a regulatory agency as set out in the First Schedule to the Act, or such other agency as the Cabinet Secretary ("the Cabinet Secretary for the time being responsible for matters relating to science and technology") may, by Order in the Gazette , determine.

Section 2Verify source

§ 3PRELIMINARY - 3. Scope of the ActProvision

The Act does not apply to genetically modified organisms that are pharmaceuticals for human use.

Section 3. Scope of the Act Section 3(1) The requirements of this Act are in addition to the requirements imposed by any other Act. Section 3(2) This Act shall not apply to genetically modified organisms that are pharmaceuticals for human use.

Section 3Verify source

§ 4PRELIMINARY - 4. Objects of the ActProvision

Facilitate responsible research into genetically modified organisms and minimize the risks they may pose.

Section 4. Objects of the Act Section to facilitate responsible research into, and minimize the risks that may be posed by, genetically modified organisms;

Section 4Verify source

Part II

ESTABLISHMENT, POWERS AND FUNCTIONS OF THE AUTHORITY

§ 10ESTABLISHMENT, POWERS AND FUNCTIONS OF THE AUTHORITY - 10. Delegation by the BoardProvision

The Board has the power to delegate its powers, functions or duties to committees, officers, staff members or agents by resolution.

Section 10. Delegation by the Board Section The Board may, by resolution either generally or in any particular case, delegate to a committee or any officer, member of staff or agent of the Board, the exercise of any of the powers or the performance of any of the functions or duties of the Board under this Act.

Section 10Verify source

§ 11ESTABLISHMENT, POWERS AND FUNCTIONS OF THE AUTHORITY - 11. Remuneration of members of the BoardProvision

Members of the Board must be paid remuneration, fees, allowances and disbursements for expenses if approved by the Cabinet Secretary.

Section 11. Remuneration of members of the Board Section The members of the Board shall be paid such remuneration, fees, allowances and disbursements for expenses as may be approved by the Cabinet Secretary ("the Cabinet Secretary for the time being responsible for matters relating to science and technology") .

Section 11Verify source

§ 12ESTABLISHMENT, POWERS AND FUNCTIONS OF THE AUTHORITY - 12. The Chief Executive OfficerProvision

The Board must appoint a Chief Executive Officer; the CEO serves for four years (renewable once subject to satisfactory performance), is an ex officio Board member without a vote, and is responsible for day-to-day management subject to the Board's direction.

Section 12. The Chief Executive Officer Section 12(1) There shall be a Chief Executive Officer of the Board who shall be appointed by the Board. Section 12(2) The Chief Executive Officer shall hold office for a period of four years, which period may be renewed once subject to satisfactory performance, as evaluated by the Board of the Authority ("the National Biosafety Authority established under;") . Section 12(3) The Chief Executive Officer shall be an ex officio member of the Board but shall have no right to vote at any meeting of the Board. Section 12(4) The Chief Executive Officer shall, subject to the direction of the Board, be responsible for the day to day management of the Authority ("the National Biosafety Authority established under;") . [ Act No. 18 of 2018 , Sch.]

Section 12Verify source

§ 13ESTABLISHMENT, POWERS AND FUNCTIONS OF THE AUTHORITY - 13. Functions of the Chief Executive OfficerProvision

The Chief Executive Officer, subject to the Board's directions, must manage the Authority's affairs and perform its functions and duties, including maintaining staff efficiency and discipline, managing the Authority's budget, and performing other duties assigned by the Authority.

Section 13. Functions of the Chief Executive Officer Section 13(1) The Chief Executive Officer shall, subject to the directions of the Board, be responsible for the management of the affairs and transactions of the Authority ("the National Biosafety Authority established under;") , the exercise, discharge and performance of its objectives, functions and duties. Section 13(2)(a) ensure the maintenance of efficiency and discipline by all staff of the Authority ("the National Biosafety Authority established under;") ; Section 13(2)(b) manage the budget of the Authority ("the National Biosafety Authority established under;") to ensure that its funds are properly expended and accounted for; Section 13(2)(c) perform such other duties as the Authority ("the National Biosafety Authority established under;") may, from time to time, assign.

Section 13Verify source

§ 14ESTABLISHMENT, POWERS AND FUNCTIONS OF THE AUTHORITY - 14. Staff of theAuthorityProvision

The Authority may employ a Corporation Secretary and other officers, agents and staff as necessary for performing the Authority's functions under this Act.

Section 14. Staff of theAuthority Section The Authority ("the National Biosafety Authority established under;") may employ a Corporation Secretary and such other officers, agents and staff as may be necessary for the performance of the functions of the Authority ("the National Biosafety Authority established under;") under this Act. [ Act No. 18 of 2018 , Sch.]

Section 14Verify source

§ 15ESTABLISHMENT, POWERS AND FUNCTIONS OF THE AUTHORITY - 15. The common seal of theAuthorityProvision

The Authority's common seal must be kept in the custody of the Chief Executive Officer or another person the Board directs, and the seal must be authenticated by the Chairperson and the Chief Executive Officer (or a Board member nominated in their absence).

Section 15. The common seal of theAuthority Section 15(1) The common seal of the Authority ("the National Biosafety Authority established under;") shall be kept in the custody of the Chief Executive Officer or of such other person as the Board may direct, and shall not be used except upon the order of the Board. Section 15(2) The common seal of the Authority ("the National Biosafety Authority established under;") , when affixed to a document and duly authenticated, shall be judicially and officially noticed, and unless the contrary is proved, any necessary order or authorisation by the Board under this section shall be presumed to have been duly given. Section 15(3) The common seal of the Authority ("the National Biosafety Authority established under;") shall be authenticated by the signature of the Chairperson of the Board and the Chief Executive Officer: Provided that the Board shall, in the absence of either the Chairperson or the Chief Executive Officer, in any particular matter, nominate one member of the Board to authenticate the seal of the Authority ("the National Biosafety Authority established under;") on behalf of either the Chairperson or the Chief Executive Officer.

Section 15Verify source

§ 16ESTABLISHMENT, POWERS AND FUNCTIONS OF THE AUTHORITY - 16. Protection from personal liabilityProvision

Members of the Board, officers, staff or agents acting bona fide in executing Authority functions are protected from personal liability to any action, claim or demand.

Section 16. Protection from personal liability Section No matter or thing done by a member of the Board or by any officer, member of staff, or agent of the Authority ("the National Biosafety Authority established under;") shall, if the matter or thing is done bona fide for executing the functions, powers or duties of the Authority ("the National Biosafety Authority established under;") under this Act, render the member, officer, employee or agent or any person acting on their directions personally liable to any action, claim or demand whatsoever.

Section 16Verify source

§ 17ESTABLISHMENT, POWERS AND FUNCTIONS OF THE AUTHORITY - 17. Liability for damagesProvision

Section 16 does not remove the Authority's liability to pay compensation or damages to persons injured by its exercise of power or by failure of works.

Section 17. Liability for damages Section The provisions of section 16 shall not relieve the Authority of the liability to pay compensation or damages to any person for any injury to him, his property or any of his interests caused by the exercise of any power conferred by this Act or any other written law or by the failure, wholly or partially, of any works.

Section 17Verify source

§ 5ESTABLISHMENT, POWERS AND FUNCTIONS OF THE AUTHORITY - 5. Establishment of theAuthorityProvision

An Authority called the National Biosafety Authority is established.

Section 5. Establishment of theAuthority Section 5(1) There is established an Authority ("the National Biosafety Authority established under;") to be known as the National Biosafety Authority ("the National Biosafety Authority established under;") . Section 5(2)(a) suing and being sued; Section 5(2)(b) taking, purchasing or otherwise acquiring, holding, charging or disposing of moveable and immovable property; Section 5(2)(c) entering into contracts; and Section 5(2)(d) doing or performing all other things or acts necessary for the proper performance of its functions under this Act, which may lawfully be done or performed by a body corporate.

Section 5Verify source

§ 6ESTABLISHMENT, POWERS AND FUNCTIONS OF THE AUTHORITY - 6. Board of theAuthorityCommencement

Section 6. Board of theAuthority Section 6(1)(a) a Chairperson who shall be an eminent scientist, appointed by the Cabinet Secretary ("the Cabinet Secretary for the time being responsible for matters relating to science and technology") ; Section 6(1)(b) the Principal Secretary in the Ministry for the time being responsible for Science and Technology or a representative; Section 6(1)(c) the Principal Secretary in the Ministry for the time being responsible for finance or a representative; Section 6(1)(d) the Principal Secretary in the Ministry for the time being responsible for agriculture or a representative; Section 6(1)(e) the Principal Secretary in the Ministry for the time being responsible for health or a representative; Section 6(1)(f) two experts in the biological, environmental and social sciences respectively, appointed by the Cabinet Secretary ("the Cabinet Secretary for the time being responsible for matters relating to science and technology") ; Section 6(1)(g) one member with financial expertise, appointed by the Cabinet Secretary ("the Cabinet Secretary for the time being responsible for matters relating to science and technology") ; and Section 6(1)(h) the Chief Executive Officer who shall be an ex officio member. Section 6(1A) Any person who, immediately before the commencement of this section was a member of the Board shall be deemed to be a member of the reconstituted Board for the unexpired period of his or her term of service. Section 6(2) The members of the Board appointed under paragraphs (b) to (e) of subsection (1) may attend in person or designate a representative to attend on their behalf. Section 6(3) The appointment of the Chairperson and the members under paragraphs (f) and (g) of subsection (1) shall be by name and by notice in the Gazette . Section 6(4) The Chairperson and members of the Board, other than the ex officio members, shall hold office for a period of three years but shall be eligible for reappointment for a further term of three years. [ Act No. 18 of 2018 , Sch.]

Section 6Verify source

§ 7ESTABLISHMENT, POWERS AND FUNCTIONS OF THE AUTHORITY - 7. Objects and functions of theAuthorityProvision

The Authority is given functions to consider approvals, coordinate and monitor safe transfer and use of genetically modified organisms, conduct research and capacity building, advise government, promote public awareness, and establish a biosafety clearing house.

Section 7. Objects and functions of theAuthority Section 7(1)(a) safety of human and animal health; Section 7(1)(b) provision of an adequate level of protection of the environment ("the physical factors of the surroundings of human beings, including land, water, atmosphere, soil, vegetation, climate, sound, odour, aesthetics, fish and wildlife;") . Section 7(2)(a) consider and determine applications for approval for the transfer, handling and use of genetically modified organisms, and related activities in accordance with the provisions of this Act; Section 7(2)(b) co-ordinate, monitor and assess activities relating to the safe transfer, handling and use of genetically modified organisms in order to ensure that such activities do not have adverse effect on human health and the environment ("the physical factors of the surroundings of human beings, including land, water, atmosphere, soil, vegetation, climate, sound, odour, aesthetics, fish and wildlife;") ; Section 7(2)(c) co-ordinate research and surveys in matters relating to the safe development, transfer, handling and use of genetically modified organisms, and to collect, collate and disseminate information about the findings of such research, investigation or survey; Section 7(2)(d) identify national requirements for manpower development and capacity building in biosafety ("the avoidance of risk to human health and safety, and the conservation of the environment, as a result of the use of genetically modified organisms;") ; Section 7(2)(e) advise the Government on legislative and other measures relating to the safe transfer, handling and use of genetically modified organisms; Section 7(2)(f) promote awareness and education among the general public in matters relating to biosafety ("the avoidance of risk to human health and safety, and the conservation of the environment, as a result of the use of genetically modified organisms;") ; and Section 7(2)(g) establish and maintain a biosafety ("the avoidance of risk to human health and safety, and the conservation of the environment, as a result of the use of genetically modified organisms;") clearing house to serve as a means through which information is made available facilitate the exchange of scientific, technical, environmental and legal information on, and experience with, living modified organisms; Section 7(2)(h) perform any other function which is incidental to the performance of any of the foregoing functions.

Section 7Verify source

§ 8ESTABLISHMENT, POWERS AND FUNCTIONS OF THE AUTHORITY - 8. Powers of the BoardProvision

The Board has the power to enter into contracts.

Section 8. Powers of the Board Section enter into contracts;

Section 8Verify source

§ 9ESTABLISHMENT, POWERS AND FUNCTIONS OF THE AUTHORITY - 9. Conduct of business and affairs of the BoardProvision

The Board must conduct its business and affairs in accordance with the Second Schedule.

Section 9. Conduct of business and affairs of the Board Section The business and affairs of the Board shall be conducted in accordance with the Second Schedule.

Section 9Verify source

Part III

APPLICATIONS FOR APPROVAL AND RISK ASSESSMENT

§ 18APPLICATIONS FOR APPROVAL AND RISK ASSESSMENT - 18. Application forcontained useactivityProvision

A person must not carry out any activity involving genetically modified organisms unless they have the written approval of the National Biosafety Authority.

Section 18. Application forcontained useactivity Section 18(1) A person shall not conduct any activity involving genetically modified organisms without the written approval of the Authority ("the National Biosafety Authority established under;") . Section 18(2)(a) be in the prescribed manner; and Section 18(2)(b) the information set out in the Third Schedule to this Act; and Section 18(2)(b)(i) the information set out in the Third Schedule to this Act; and Section 18(2)(b)(ii) such other information that the applicant ("a person submitting an application pursuant to the provisions of this Act;") or the Authority ("the National Biosafety Authority established under;") may consider necessary for the assessment of the potential risk or benefits of the particular contained use ("any activity undertaken within a facility, installation or other physical structure which involves genetically modified organisms that are controlled by specific measures;") activity.

Section 18Verify source

§ 19APPLICATIONS FOR APPROVAL AND RISK ASSESSMENT - 19. Application to introduce into theenvironmentProvision

Persons must not introduce genetically modified organisms into the environment without the Authority's written approval; applicants must submit an application to the Authority; the Authority must publish notice of applications; any person may make representations within thirty days of publication.

Section 19. Application to introduce into theenvironment Section 19(1) A person shall not introduce into the environment ("the physical factors of the surroundings of human beings, including land, water, atmosphere, soil, vegetation, climate, sound, odour, aesthetics, fish and wildlife;") a genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") without the written approval of the Authority ("the National Biosafety Authority established under;") . Section 19(2) A person wishing to introduce a genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") into the environment ("the physical factors of the surroundings of human beings, including land, water, atmosphere, soil, vegetation, climate, sound, odour, aesthetics, fish and wildlife;") shall submit to the Authority ("the National Biosafety Authority established under;") an application describing the activity for which the approval is sought. Section 19(3)(a) be in the prescribed manner; Section 19(3)(b) the information set out in the Fourth Schedule; and Section 19(3)(b)(i) the information set out in the Fourth Schedule; and Section 19(3)(b)(ii) such other information that the applicant ("a person submitting an application pursuant to the provisions of this Act;") or the Authority ("the National Biosafety Authority established under;") may consider necessary for the assessment of the potential risk or benefits of the introduction of the particular genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") into the environment ("the physical factors of the surroundings of human beings, including land, water, atmosphere, soil, vegetation, climate, sound, odour, aesthetics, fish and wildlife;") . Section 19(4) The Authority ("the National Biosafety Authority established under;") shall publish in the Gazette , at least two newspapers with nationwide circulation, and in an appropriate electronic media, notice concerning any application for release into the environment ("the physical factors of the surroundings of human beings, including land, water, atmosphere, soil, vegetation, climate, sound, odour, aesthetics, fish and wildlife;") of a genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") , for the general information of the public. Section 19(5) Any person may, within thirty days from the date of publication of the notice, make representations to the Authority ("the National Biosafety Authority established under;") regarding such an application, and the Authority ("the National Biosafety Authority established under;") shall address appropriately any relevant concerns raised by such a person.

Section 19Verify source

§ 20APPLICATIONS FOR APPROVAL AND RISK ASSESSMENT - 20. Application for importationProvision

Persons must not import genetically modified organisms into Kenya without the written approval of the Authority.

Section 20. Application for importation Section 20(1) A person shall not import into Kenya a genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") without the written approval of the Authority ("the National Biosafety Authority established under;") . Section 20(2)(a) be in the prescribed manner; Section 20(2)(b) the information set out in the Fourth Schedule; Section 20(2)(b)(i) the information set out in the Fourth Schedule; Section 20(2)(b)(ii) such other information that the applicant ("a person submitting an application pursuant to the provisions of this Act;") or the Authority ("the National Biosafety Authority established under;") may consider necessary for the assessment of the potential risk or benefits of importation of the particular genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") .

Section 20Verify source

§ 21APPLICATIONS FOR APPROVAL AND RISK ASSESSMENT - 21. Application forplacing on the marketProvision

A person must not place a genetically modified organism on the market without the written approval of the Authority (National Biosafety Authority).

Section 21. Application forplacing on the market Section 21(1) A person shall not place on the market a genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") without the written approval of the Authority ("the National Biosafety Authority established under;") . Section 21(2)(a) be in the prescribed manner; Section 21(2)(b) the information set out in the Fourth Schedule; and Section 21(2)(b)(i) the information set out in the Fourth Schedule; and Section 21(2)(b)(ii) such other information that the applicant ("a person submitting an application pursuant to the provisions of this Act;") or the Authority ("the National Biosafety Authority established under;") may consider necessary for the assessment of the potential risk or benefits of the placement of the particular genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") on the market.

Section 21Verify source

§ 22APPLICATIONS FOR APPROVAL AND RISK ASSESSMENT - 22. Genetically modified organisms in transitProvision

Requires written approval from the Authority for transportation of genetically modified organisms and that such organisms be properly packaged and transported in accordance with prescribed regulations and international standards; applications to transport through Kenya must be in the prescribed manner.

Section 22. Genetically modified organisms in transit Section 22(1)(a) apply for a written approval of such transportation from the Authority ("the National Biosafety Authority established under;") ; and Section 22(1)(b) ensure that the genetically modified organisms being transported are properly packaged and transported in accordance with such regulations as may be prescribed and any applicable international standards. Section 22(2) An application to transport genetically modified organisms through Kenya shall be in the prescribed manner.

Section 22Verify source

§ 23APPLICATIONS FOR APPROVAL AND RISK ASSESSMENT - 23. Application to exportProvision

Persons intending to export genetically modified organisms must provide the National Biosafety Authority with advance written consent from the destination country's relevant authority stating no objection to the export.

Section 23. Application to export Section A person intending to export a genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") from Kenya shall provide the Authority ("the National Biosafety Authority established under;") with an advance written consent granted by a relevant authority of the country to which the genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") is destined, to the effect that such relevant authority has no objection to the intended exportation.

Section 23Verify source

§ 24APPLICATIONS FOR APPROVAL AND RISK ASSESSMENT - 24. Withdrawal of applicationProvision

An applicant may withdraw their application any time before the Authority issues a final decision.

Section 24. Withdrawal of application Section A person applying for any approval may withdraw his application at any time prior to the issuance of a final decision by the Authority ("the National Biosafety Authority established under;") .

Section 24Verify source

§ 25APPLICATIONS FOR APPROVAL AND RISK ASSESSMENT - 25. Confidential informationProvision

Section 25 sets rules on confidential information: applicants may designate information as confidential, and the National Biosafety Authority decides, informs of rejections, must protect confidential information and must not use it for unauthorized purposes; it must also respect confidentiality when an applicant withdraws.

Section 25. Confidential information Section 25(1)(a) allow an applicant ("a person submitting an application pursuant to the provisions of this Act;") to identify information provided to the Authority ("the National Biosafety Authority established under;") in accordance with the requirements of this Act and any regulations made hereunder, that is to be treated as confidential, with justification for claims of confidentiality to be provided upon request; Section 25(1)(b) decide whether it accepts as confidential the information designated by the applicant ("a person submitting an application pursuant to the provisions of this Act;") ; Section 25(1)(c) inform the applicant ("a person submitting an application pursuant to the provisions of this Act;") of any rejection of the claim of confidentiality, providing reasons on request, as well as an opportunity for consultation; and Section 25(1)(d) in the event that an applicant ("a person submitting an application pursuant to the provisions of this Act;") withdraws an application in accordance with section 24 , respect the applicant’s claims of confidentiality. Section 25(2) The Authority ("the National Biosafety Authority established under;") shall not use confidential information for any purpose not authorized under this Act, and shall ensure that such information is protected by any person involved in handling applications under this Act.

Section 25Verify source

§ 26APPLICATIONS FOR APPROVAL AND RISK ASSESSMENT - 26. Acknowledgement of applicationProvision

The National Biosafety Authority must screen applications for completeness and must acknowledge receipt in writing within thirty days; if incomplete it must request additional information, and time waiting for that information is not counted towards the Authority's decision time.

Section 26. Acknowledgement of application Section 26(1) Upon receipt of an application, the Authority ("the National Biosafety Authority established under;") shall screen the application for completeness and shall, within thirty days from the date of receipt, acknowledge receipt of the application in writing. Section 26(2) Where an application is not complete, the Authority ("the National Biosafety Authority established under;") shall request the applicant ("a person submitting an application pursuant to the provisions of this Act;") to submit additional information. Section 26(3) Where the Authority ("the National Biosafety Authority established under;") requests for additional information from the applicant ("a person submitting an application pursuant to the provisions of this Act;") , the time taken before getting the information shall not be reckoned by the Authority ("the National Biosafety Authority established under;") in calculating the time taken prior to making a final decision on the application.

Section 26Verify source

§ 27APPLICATIONS FOR APPROVAL AND RISK ASSESSMENT - 27. Risk assessment and risk managementProvision

The National Biosafety Authority must, upon completion of a risk assessment, make a report of its findings and indicate measures for safe use of a genetically modified organism, and must liaise with the appropriate regulatory agency to ensure measures are in place to manage and control identified risks.

Section 27. Risk assessment and risk management Section 27(1)(a) subject to section 28 , undertake a risk assessment in terms of the provisions of the Fifth Schedule; and Section 27(1)(b) audit risk assessment information submitted by the applicant ("a person submitting an application pursuant to the provisions of this Act;") , if any. Section 27(2) Risk assessment under this section shall be carried out taking into account available information concerning any known risk posed by potential exposure to a genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") . Section 27(3) Upon completion of the risk assessment, the Authority ("the National Biosafety Authority established under;") shall make a report of its findings, and shall indicate any measures to be taken to ensure the safe use of a genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") . Section 27(4) The Authority ("the National Biosafety Authority established under;") shall liaise with the appropriate regulatory agency ("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, determine") to ensure that appropriate measures are in place to manage and control risks identified during the risk assessment process.

Section 27Verify source

§ 28APPLICATIONS FOR APPROVAL AND RISK ASSESSMENT - 28. Non-assessment of risksProvision

Section 28. Non-assessment of risks Section The Authority ("the National Biosafety Authority established under;") may opt not to undertake a risk assessment for purposes of sections 18 , 19 and 20 , where it determines that sufficient experience or information exists to conclude that the genetically modified organism or contained use activity concerned do not pose a significant risk.

Section 28Verify source

§ 29APPLICATIONS FOR APPROVAL AND RISK ASSESSMENT - 29. Determination of an applicationProvision

Before deciding on an application under section 19, the National Biosafety Authority must consider specified information (applicant submissions, regulatory agency information and conditions, risk assessment report, public representations, and socio‑economic/environmental impacts) and must liaise with the relevant regulatory agency, which must submit any conditions it considers appropriate.

Section 29. Determination of an application Section 29(1)(a) the information submitted by the applicant ("a person submitting an application pursuant to the provisions of this Act;") ; Section 29(1)(b) such information and conditions as may be submitted by the relevant regulatory agency ("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, determine") ; Section 29(1)(c) the risk assessment report; Section 29(1)(d) any relevant representations submitted by members of the public; and Section 29(1)(e) socio-economic considerations arising from the impact of the genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") on the environment ("the physical factors of the surroundings of human beings, including land, water, atmosphere, soil, vegetation, climate, sound, odour, aesthetics, fish and wildlife;") , where the decision relates to an application under section 19 of this Act. Section 29(2) The Authority ("the National Biosafety Authority established under;") shall, prior to determining an application, liaise with the relevant regulatory agency ("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, determine") , and such regulatory agency ("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, determine") shall submit to the Authority ("the National Biosafety Authority established under;") any conditions that the regulatory agency ("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, determine") considers appropriate to be attached to the approval.

Section 29Verify source

§ 30APPLICATIONS FOR APPROVAL AND RISK ASSESSMENT - 30. Communication of decisionProvision

The National Biosafety Authority must communicate its final decision (approval or rejection) to the applicant within 150 days of receiving the application, but not earlier than 90 days.

Section 30. Communication of decision Section 30(1) The Authority ("the National Biosafety Authority established under;") shall communicate its final decision of approval or rejection of the application to the applicant ("a person submitting an application pursuant to the provisions of this Act;") , within one hundred and fifty days of the receipt of the application but not earlier than ninety days of such receipt. Section 30(2)(a) shall be specific to the activity authorized; and Section 30(2)(b) if granted subject to some conditions, including such conditions as may be given by an appropriate regulatory agency ("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, determine") , shall clearly state such conditions. Section 30(3) Where an application for approval is rejected, the reasons for such rejection shall be clearly stated.

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§ 31APPLICATIONS FOR APPROVAL AND RISK ASSESSMENT - 31. Suspension or revocation of an approvalProvision

The National Biosafety Authority may suspend or revoke an approval for contravening conditions or the Act; before doing so it must give written notice and invite representations within thirty days; if it suspends or revokes it must publish the order in the Gazette, two nationwide newspapers and an appropriate electronic media.

Section 31. Suspension or revocation of an approval Section 31(1) The Authority ("the National Biosafety Authority established under;") may suspend or revoke any approval given under this Act where the person who has been granted such approval is in contravention of any of the conditions imposed on the grant of the approval, or the provisions of this Act. Section 31(2) The Authority ("the National Biosafety Authority established under;") shall, before suspending or revoking an approval, give a written notice of its intention to suspend or revoke the approval to the person upon whom it is given, and shall accordingly invite such person to make representations within thirty days from the date of such notice. Section 31(3) Where the Authority ("the National Biosafety Authority established under;") suspends or revokes an approval, it shall publish the order suspending or revoking the approval in the Gazette , at least two newspapers with nationwide circulation, and in an appropriate electronic media.

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§ 32APPLICATIONS FOR APPROVAL AND RISK ASSESSMENT - 32. RegisterProvision

Section 32. Register Section every application received;

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Part IV

REVIEW AND APPEALS

§ 33REVIEW AND APPEALS - 33. Review of decisionSubstitution

The National Biosafety Authority may review approvals when there is significant new scientific information or a material change in circumstances and must substitute approvals, decide reviews within 100 days, take immediate safety action when activities threaten biosafety, and give special consideration to requests from a regulatory agency.

Section 33. Review of decision Section 33(1) The Authority ("the National Biosafety Authority established under;") may review a decision made under section 29 of this Act at any time upon obtaining significant new scientific information relating to biosafety of the genetically modified organism or contained use activity involved. Section 33(2)(a) a change in circumstances has occurred that may have a material effect on the outcome of the risk assessment upon which the decision was based; or Section 33(2)(b) additional scientific or technical information has become available that may have a material effect on the decision or any conditions, limitations or requirements imposed under a decision. Section 33(3) If upon review the Authority ("the National Biosafety Authority established under;") is satisfied that a change is warranted, the Authority ("the National Biosafety Authority established under;") shall substitute its earlier approval with another approval which shall take into account the changed circumstances. Section 33(4) The Authority ("the National Biosafety Authority established under;") shall make a decision on a review within one hundred days from the date of request for the review and shall state clearly the reasons for its decision. Section 33(5) Where the Authority ("the National Biosafety Authority established under;") has knowledge that an activity poses a threat to biosafety ("the avoidance of risk to human health and safety, and the conservation of the environment, as a result of the use of genetically modified organisms;") , the Authority ("the National Biosafety Authority established under;") shall take immediate action to put necessary safety measures in place. Section 33(6) The Authority ("the National Biosafety Authority established under;") shall give special consideration for review requests from a regulatory agency ("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, determine") .

Section 33Verify source

§ 34REVIEW AND APPEALS - 34. Offence of withholding informationOffence

It is an offence for a person who has been granted approval to withhold information that becomes available before or after approval and could change the evaluation of risk; on conviction the person is liable to a fine not exceeding two million shillings, or imprisonment for a term not exceeding ten years, or both.

Section 34. Offence of withholding information Section Where a person upon whom approval has been granted withholds information that becomes available to him before and after the approval of his application, and the information could reasonably be expected to change the evaluation of the risk posed by the person’s intended activity, such person 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 34Verify source

§ 35REVIEW AND APPEALS - 35. Establishment of the Appeals BoardProvision

Section establishes an Appeals Board, sets appointment roles (Chairperson and four experts) appointed by the Cabinet Secretary, states members hold office for three years, allows aggrieved persons to appeal to the High Court within thirty days, gives the Appeals Board power to regulate its procedure and prescribe appeal manner, fees and costs, and requires appointments by Gazette.

Section 35. Establishment of the Appeals Board Section 35(1)(a) a Chairperson who shall be an advocate of the High Court qualified for appointment as a judge of the High Court of Kenya, appointed by the Cabinet Secretary ("the Cabinet Secretary for the time being responsible for matters relating to science and technology") ; Section 35(1)(b) four other persons, each of whom shall be an expert in either biological, environmental or social sciences, appointed by the Cabinet Secretary ("the Cabinet Secretary for the time being responsible for matters relating to science and technology") . Section 35(2) Appointments to the Appeals Board shall be by notice in the Gazette . Section 35(3) A member of the Appeals Board shall hold office for three years. Section 35(4)(a) a refusal to grant an approval; Section 35(4)(b) the imposition of any conditions on an approval; Section 35(4)(c) the revocation, suspension or variation of an approval; Section 35(4)(d) a refusal to treat an application as confidential; Section 35(4)(e) a decision of a biosafety ("the avoidance of risk to human health and safety, and the conservation of the environment, as a result of the use of genetically modified organisms;") inspector; Section 35(4)(f) any other decision of the Authority ("the National Biosafety Authority established under;") under this Act, Section 35(5) Any person aggrieved by a decision of the Appeals Board may, within thirty days of the making of the decision, appeal against the decision to the High Court. Section 35(6) The decision of the High Court on any appeal under this section shall be final. Section 35(7) Subject to subsection (8), the Appeals Board shall regulate its own procedure. Section 35(8)(a) prescribing the manner in which an appeal shall be made to the Appeals Board and the fees to be paid in respect of an appeal; Section 35(8)(b) prescribing a scale of costs which may be awarded by the Appeals Board; and Section 35(8)(c) generally for the better carrying out of the provisions of this Act relating to the Appeals Board and appeals thereto. Section 35(9) The Appeals Board shall communicate its final decision to the appellant within ninety days from the date the appeal was made.

Section 35Verify source

§ 36REVIEW AND APPEALS - 36. Powers of the Appeals BoardProvision

The Appeals Board has court-like powers to summon witnesses, take evidence on oath or affirmation, call for documents, receive affidavit evidence, administer interrogatories, consider otherwise inadmissible evidence, award and have costs taxed, and summonses under the Chairperson are deemed to be issued by the Board.

Section 36. Powers of the Appeals Board Section 36(1) On hearing an appeal, the Appeals Board shall have the powers of a court to summon witnesses, take evidence upon oath or affirmation, and to call for the production of books and other documents. Section 36(2) Where the Appeals Board considers it desirable for the purpose of avoiding expense or delay or any other special reason so to do, it may receive evidence by affidavit and administer interrogatories and require the person to whom interrogatories are administered to make a full and true reply to the interrogatories within the time specified by the Appeals Board. Section 36(3) In the determination of any matter, the Appeals Board may take into consideration any evidence which it considers relevant to the subject of an appeal before it, notwithstanding that such evidence would not otherwise be admissible under the law relating to evidence. Section 36(4) The Appeals Board shall have the power to award the costs of any proceedings before it and to direct that costs shall be taxed in accordance with any scale prescribed. Section 36(5) All summonses, notices or other documents issued under the hand of the Chairperson of the Appeals Board shall be deemed to be issued by the Appeals Board. Section 36(6) Any interested party may be represented before the Appeals Board by an advocate or by any other person whom the Appeals Board may admit to be heard on behalf of the party.

Section 36Verify source

§ 37REVIEW AND APPEALS - 37. Provisions as to the Appeals BoardProvision

The provisions of the Sixth Schedule apply to the Appeals Board.

Section 37. Provisions as to the Appeals Board Section The provisions of the Sixth Schedule shall apply to the Appeals Board.

Section 37Verify source

Part IX

MISCELLANEOUS

§ 50MISCELLANEOUS - 50. Handling, packaging, etc., of genetically modified organismsProvision

Any person manufacturing or importing genetically modified organisms must ensure that their handling, packaging, identification and transportation are done in the prescribed manner.

Section 50. Handling, packaging, etc., of genetically modified organisms Section Any person manufacturing or importing any genetically modified organisms shall ensure that the handling, packaging, identification and transportation of genetically modified organisms is done in the prescribed manner.

Section 50Verify source

§ 51MISCELLANEOUS - 51. RegulationsProvision

Provides for regulations to prescribe anything required by this Act.

Section 51. Regulations Section anything required by this Act to be prescribed;

Section 51Verify source

§ 52MISCELLANEOUS - 52. Offences and penaltiesOffence

Certain activities involving genetically modified organisms — contained use, release into the environment, placing on the market, import or export — are linked to a requirement for approval of the Authority.

Section 52. Offences and penalties Section makes contained use ("any activity undertaken within a facility, installation or other physical structure which involves genetically modified organisms that are controlled by specific measures;") of, releases into the environment ("the physical factors of the surroundings of human beings, including land, water, atmosphere, soil, vegetation, climate, sound, odour, aesthetics, fish and wildlife;") , places on the market, imports or exports a genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") without the approval of the Authority ("the National Biosafety Authority established under;") ;

Section 52Verify source

§ 53MISCELLANEOUS - 53. Restriction on institution of proceedingsOffence

No proceedings for an offence under this Act may be instituted without the prior written consent of the Director of Public Prosecutions.

Section 53. Restriction on institution of proceedings Section No proceedings for an offence under this Act shall be instituted without a prior written consent of the Director of Public Prosecutions. [Act No. 19 of 2023 , Sch.]

Section 53Verify source

§ 54MISCELLANEOUS - 54. Public awareness and participationProvision

The National Biosafety Authority must promote public awareness on biosafety, publish guidance materials, notify the Gazette of approval decisions, provide records on request for a fee, and any person may submit written comments within thirty days of a posted notice.

Section 54. Public awareness and participation Section 54(1) The Authority ("the National Biosafety Authority established under;") shall promote public awareness and education of the public and those conducting the activities subject to the Act, concerning biosafety ("the avoidance of risk to human health and safety, and the conservation of the environment, as a result of the use of genetically modified organisms;") matters, through the publication of guidance documents and other materials aimed at improving the understanding of biosafety ("the avoidance of risk to human health and safety, and the conservation of the environment, as a result of the use of genetically modified organisms;") . Section 54(2) The Authority ("the National Biosafety Authority established under;") shall give notice in the Gazette of all decisions made regarding applications for approval. Section 54(3) Upon request, the Authority ("the National Biosafety Authority established under;") shall, upon payment of the prescribed fee, avail to any person copies of records kept under section 32 , including details of any application that do not qualify as confidential information. Section 54(4) Any person may submit written comments on a proposed decision for any application for placing a genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") on the market, within thirty days from the date the notice is posted.

Section 54Verify source

Part V

REGULATORY AGENCIES

§ 38REGULATORY AGENCIES - 38. Consultation with regulatory agenciesProvision

The National Biosafety Authority must coordinate activities involving genetically modified organisms and may consult relevant regulatory agencies; regulatory agencies must monitor approved activities and must inform the Authority immediately of significant new scientific information indicating previously unknown biosafety risks.

Section 38. Consultation with regulatory agencies Section 38(1) The Authority ("the National Biosafety Authority established under;") shall coordinate all activities involving genetically modified organisms and in carrying out its role of coordination, the Authority ("the National Biosafety Authority established under;") may consult with the relevant regulatory agency ("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, determine") . Section 38(2) Regulatory agencies shall, where appropriate, monitor any activity for which approval has been granted by the Authority ("the National Biosafety Authority established under;") to ensure that such an activity complies with conditions imposed, if any, on the grant of an approval. Section 38(3) Where a regulatory agency ("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, determine") , in carrying out its mandate, becomes aware of any significant new scientific information indicating that approved activities with genetically modified organisms may pose potential biosafety ("the avoidance of risk to human health and safety, and the conservation of the environment, as a result of the use of genetically modified organisms;") risks not previously known, the regulatory agency ("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, determine") shall immediately inform the Authority ("the National Biosafety Authority established under;") of the new information and of the measures proposed to be put in place to ensure the continued safe use of the genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") .

Section 38Verify source

§ 39REGULATORY AGENCIES - 39. Unintentional release into theenvironmentProvision

A regulatory agency that knows of an unintentional or unapproved introduction of a genetically modified organism likely to pose biosafety risks must notify the National Biosafety Authority within twenty-four hours.

Section 39. Unintentional release into theenvironment Section 39(1) A regulatory agency ("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, determine") with knowledge of an unintentional or unapproved introduction into the environment ("the physical factors of the surroundings of human beings, including land, water, atmosphere, soil, vegetation, climate, sound, odour, aesthetics, fish and wildlife;") of a genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") that is likely to pose biosafety ("the avoidance of risk to human health and safety, and the conservation of the environment, as a result of the use of genetically modified organisms;") risks shall, within twenty-four hours of knowledge of the introduction, notify the Authority ("the National Biosafety Authority established under;") of the occurrence. Section 39(2) A notification under this section shall include such adequate information as would enable the Authority ("the National Biosafety Authority established under;") to mitigate any adverse effects to both human beings and the environment ("the physical factors of the surroundings of human beings, including land, water, atmosphere, soil, vegetation, climate, sound, odour, aesthetics, fish and wildlife;") . Section 39(3) The Authority ("the National Biosafety Authority established under;") shall, in consultation with the regulatory agency ("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, determine") concerned, determine whether any action is necessary to minimize any biosafety ("the avoidance of risk to human health and safety, and the conservation of the environment, as a result of the use of genetically modified organisms;") risks.

Section 39Verify source

Part VI

RESTORATION AND CESSATION ORDERS

§ 40RESTORATION AND CESSATION ORDERS - 40. Environmental restoration orderProvision

The National Biosafety Authority may issue and serve a restoration order relating to the release of a genetically modified organism into the environment.

Section 40. Environmental restoration order Section 40(1) The Authority ("the National Biosafety Authority established under;") may issue and serve on any person a restoration order in respect of any matter relating to release of a genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") into the environment ("the physical factors of the surroundings of human beings, including land, water, atmosphere, soil, vegetation, climate, sound, odour, aesthetics, fish and wildlife;") . Section 40(2)(a) require the person on whom it is served to restore the environment ("the physical factors of the surroundings of human beings, including land, water, atmosphere, soil, vegetation, climate, sound, odour, aesthetics, fish and wildlife;") as near as it may be to the state in which it was before the release of a genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") ; Section 40(2)(b) levy a charge on the person on whom it is served which, in the opinion of the Authority ("the National Biosafety Authority established under;") , represents a reasonable estimate of the costs of any action taken by an authorized person or organization to restore the environment ("the physical factors of the surroundings of human beings, including land, water, atmosphere, soil, vegetation, climate, sound, odour, aesthetics, fish and wildlife;") to the state in which it was before the release of a genetically modified organism ("any organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology techniques;") .

Section 40Verify source

§ 41RESTORATION AND CESSATION ORDERS - 41. Contents of restoration orderProvision

Contents of restoration order: the activity to which it relates

Section 41. Contents of restoration order Section the activity to which it relates;

Section 41Verify source

§ 42RESTORATION AND CESSATION ORDERS - 42. Cessation ordersProvision

Section 42 allows cessation orders to be withdrawn by the Authority when it determines sufficient information exists to permit the activity to resume safely.

Section 42. Cessation orders Section 42(1)(a) one or more tests conducted and evaluated in a manner consistent with acceptable scientific procedures; Section 42(1)(b) other validated scientific evidence. Section 42(2)(a) upon the failure of any person issued with an approval to demonstrate compliance with such approval after a reasonable period of time; or Section 42(2)(b) in the event of non-compliance with the provisions of this Act or regulations made thereunder. Section 42(3) A cessation order issued under this Act may be withdrawn once the Authority ("the National Biosafety Authority established under;") determines that sufficient information exists to permit the activity concerned to resume, or to resume in the presence of additional risk management measures, without posing a significant risk to human health and the environment ("the physical factors of the surroundings of human beings, including land, water, atmosphere, soil, vegetation, climate, sound, odour, aesthetics, fish and wildlife;") .

Section 42Verify source

Part VII

INSPECTION AND MONITORING

§ 43INSPECTION AND MONITORING - 43. Appointment ofbiosafetyinspectorsProvision

The Cabinet Secretary may, on the Authority's recommendation and by notice in the Gazette, appoint qualified persons as biosafety inspectors for specified jurisdictional units.

Section 43. Appointment ofbiosafetyinspectors Section The Cabinet Secretary ("the Cabinet Secretary for the time being responsible for matters relating to science and technology") may, on the recommendation of the Authority ("the National Biosafety Authority established under;") , and by notice in the Gazette , appoint duly qualified persons whether by name or by title of office, to be biosafety ("the avoidance of risk to human health and safety, and the conservation of the environment, as a result of the use of genetically modified organisms;") inspectors of the Authority ("the National Biosafety Authority established under;") , for such jurisdictional units as may be specified in the notice of appointment.

Section 43Verify source

§ 44INSPECTION AND MONITORING - 44. Functions ofbiosafetyinspectorsProvision

Biosafety inspectors must monitor compliance with this Act and the regulations made thereunder.

Section 44. Functions ofbiosafetyinspectors Section monitor compliance with this Act and regulations made thereunder;

Section 44Verify source

§ 45INSPECTION AND MONITORING - 45. Powers ofbiosafetyinspectorsProvision

Section 45 lists powers of a biosafety inspector including entry to premises, taking equipment, conducting tests and inspections, directing that premises remain undisturbed, taking samples, dismantling or testing items suspected to contain GMOs (without unnecessary damage), and requiring production of records; it also requires the inspector to suitably identify himself when exercising powers.

Section 45. Powers ofbiosafetyinspectors Section 45(1)(a) enter any premises, facility, vessel or property which the inspector has reason to believe it is necessary for him to enter in order to ascertain whether the requirements of this Act or any approval under this Act are being complied with, and may take with him any person duly authorized by the Authority ("the National Biosafety Authority established under;") ; Section 45(1)(b) take with him any equipment or material required for any purpose for which the power of entry is being exercised; Section 45(1)(c) carry out such tests and inspections, and make such recordings as may be necessary in the circumstances; Section 45(1)(d) direct that any part of premises which he has power to enter, or anything in such premises, shall be left undisturbed for so long as is reasonably necessary for the purpose of any test or inspection; Section 45(1)(e) take appropriate samples of any organisms, articles or substances found in any premises which he has power to enter for analysis or any other relevant purpose under this Act; Section 45(1)(f) in the case of anything found in the premises which he has power to enter, which appears to him to contain genetically modified organisms which pose biosafety ("the avoidance of risk to human health and safety, and the conservation of the environment, as a result of the use of genetically modified organisms;") risk, cause it to be dismantled or subjected to any process or test but not so as to damage or destroy it, unless it is necessary; Section 45(1)(g) require the production of any records which may be required to be kept under this Act. Section 45(2) When exercising his powers under this Act, a biosafety ("the avoidance of risk to human health and safety, and the conservation of the environment, as a result of the use of genetically modified organisms;") inspector shall suitably identify himself.

Section 45Verify source

Part VIII

FINANCIAL PROVISIONS

§ 46FINANCIAL PROVISIONS - 46. Funds of theAuthorityProvision

Parliament may appropriate moneys for the purposes of the Authority.

Section 46. Funds of theAuthority Section such moneys as may be appropriated by Parliament for the purposes of the Authority ("the National Biosafety Authority established under;") ;

Section 46Verify source

§ 47FINANCIAL PROVISIONS - 47. Annual estimatesCommencement

The Board must prepare and approve annual estimates of the Authority's revenue and expenditure; the Board may create reserve funds as it deems fit.

Section 47. Annual estimates Section 47(1) At least three months before the commencement of each financial year ("the period of twelve months ending on the thirtieth June in each year;") , the Board shall cause to be prepared estimates of the revenue and expenditure of the Authority ("the National Biosafety Authority established under;") for that financial year ("the period of twelve months ending on the thirtieth June in each year;") . Section 47(2)(a) the payment of the salaries, allowances and other charges in respect of the officers, members of staff, or agents of the Authority ("the National Biosafety Authority established under;") ; Section 47(2)(b) the payment of the pensions, gratuities and other charges in respect of retirement benefits payable to the members of staff of the Authority ("the National Biosafety Authority established under;") ; Section 47(2)(c) the proper maintenance of the buildings and grounds of the Authority ("the National Biosafety Authority established under;") ; Section 47(2)(d) the proper maintenance, repair and replacement of the equipment and other movable property of the Authority ("the National Biosafety Authority established under;") ; and Section 47(2)(e) the creation of such reserve funds to meet future or contingent liabilities in respect of retirement benefits, insurance, replacement of buildings or equipment, or in respect of such other matters as the Board may deem fit. Section 47(3) The annual estimates shall be approved by the Board before the commencement of the financial year ("the period of twelve months ending on the thirtieth June in each year;") to which they relate and, once approved, the sum provided in the estimates shall be submitted to the Cabinet Secretary ("the Cabinet Secretary for the time being responsible for matters relating to science and technology") for approval. Section 47(4) No expenditure shall be incurred for the purposes of the Authority ("the National Biosafety Authority established under;") except in accordance with the annual estimates approved under subsection (3), or in pursuance of an authorisation of the Board given with prior written approval of the Cabinet Secretary ("the Cabinet Secretary for the time being responsible for matters relating to science and technology") , and the Principal Secretary to the Treasury.

Section 47Verify source

§ 48FINANCIAL PROVISIONS - 48. Accounts and auditProvision

The Board must ensure proper books and other records of the Authority's income, expenditure, assets and liabilities are kept.

Section 48. Accounts and audit Section 48(1) The Board shall cause to be kept proper books and other records of accounts of the income, expenditure, assets and liabilities of the Authority ("the National Biosafety Authority established under;") . Section 48(2)(a) a statement of income and expenditure during that financial year ("the period of twelve months ending on the thirtieth June in each year;") ; and Section 48(2)(b) a statement of the assets and liabilities of the Authority ("the National Biosafety Authority established under;") on the last day of that financial year ("the period of twelve months ending on the thirtieth June in each year;") . Section 48(3) The accounts of the Authority ("the National Biosafety Authority established under;") shall be examined, audited and reported upon annually by the Auditor-General in accordance with the provisions of the Public Audit Act ( Cap. 412B ).

Section 48Verify source

§ 49FINANCIAL PROVISIONS - 49. Investment of fundsProvision

Allows the Board to invest trust funds in securities and allows the Treasury to approve other securities for investment.

Section 49. Investment of funds Section invest any of the funds of the Authority ("the National Biosafety Authority established under;") in securities in which the Board may by law invest trust funds, or in any other securities which the Treasury may, from time to time, approve;

Section 49Verify source

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Section 48

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