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.

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

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.

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.

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

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).

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 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.

An Authority called the National Biosafety Authority is established.

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 reappointment.

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.

The Board has the power to enter into contracts.

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

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

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.

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

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

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

Register every application received.

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.

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 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.

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.

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

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

Provides for regulations to prescribe anything required by this Act.

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.

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

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.

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.

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.

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

Contents of restoration order: the activity to which it relates

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

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.

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

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.

Parliament may appropriate moneys for the purposes of the Authority.

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.

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

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