Biosafety Act

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

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...

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

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 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 Exe...

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...

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

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 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 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 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 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 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 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 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 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 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 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...

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 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 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 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 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 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 un...

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 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...

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 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...

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.

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.

Section 32. Register Section every application received;

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...

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 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 organ...

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...

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

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

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 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 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...

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 av...

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 a...

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 B...

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

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

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 c...