THE BIOSAFETY BILL, 2007 JACARANDA HOTEL, 26 TH JULY 2007

BACKGROUND TO THE BILL Research activities in the country- these were going on and were guided by the Science and Technology Act, Ratification of the Cartagena Protocol on Biosafety- Kenya was the first country to sign the protocol. Kenya ratified the protocol in Sept 2003 The objectives of the Protocol were to ensure an adequate level of protection in the field of safe transfer, handling and use of genetically modified organisms resulting from modern biotechnology that may have an adverse effect on the human health and environment and to establish a transparent and predictable process to review and make decisions on such genetically modified organisms and related activities. Setting up of the National Biosafety Committee Draft regulations and guidelines- but guidelines lacked legal basis, hence drafting of a new law Consultative process- process involved all the relevant stakeholders

JUSTIFICATION International obligation- Having ratified the protocol, it is necessary that Kenya observes its obligations under the protocol. Need to take research to the market- commercializing products whose efficacy and safety has been proven scientifically, would enable farmers all the present and future options to gain higher income from commercial adoption of GM crops Legal framework- A comprehensive Biosafety legal framework strikes a balance between ensuring the development of biotechnology and safeguarding the interests of consumers and the environment

PROVISIONS OF THE BILL Preliminary provisions Administrative provisions Handling requests and risk assessment Review and appeal Role of regulatory agencies Inspections Financial provisions Miscellaneous provisions

PRELIMINARY PROVISIONS Title of the Bill- the Biosafety Bill Interpretation section biosafety Genetically modified organisms Scope of the Act The Act will not cover genetically modified pharmaceuticals as they are already covered under the WHO guidelines and which the Ministry of Health has adopted

ADMINISTRATIVE PROVISIONS The Bill Establishes a National Biosafety Authority, which shall be a body corporate The Bill sets up a representative Board of management comprising of regulatory offices, consumers, industry and farmers. the Bill also provides for the appointment of a CEO of the Authority. The CEO will carry out the day-to- day activities of the Authority

HANDLING REQUESTS AND RISK ASSESSMENT The Act requires that any one wishing to carry out activities involving GMOs i.e. research, introduction into the environment, importing exporting, transiting through Kenya, placing on the market (selling), will only do so with the approval of the Board Prior to making a decision on whether to allow or reject an application, the Board will carry out a risk assessment.

RISK ASSESSMENT Risk assessment entails identifying and evaluating the potential adverse effects of genetically modified organisms on human health and the environment. Risk assessment includes- an identification of any genotype and phenotypic characteristics associated with the genetically modified organisms that may have adverse effects on the environment and on human health an evaluation of the likelihood of these adverse effects being realized, taking into account the level and the kind of exposure of the likely potential receiving environment of the genetically modified organisms, an evaluation of the consequences should these effects be realized, an estimation of the overall risk posed by the genetically modified organisms based on the evaluation of the likelihood and consequences of the identified adverse effects being realized,

REVIEW AND APPEALS An review of a decision may be done by the Authority at any time upon obtaining significant new scientific information relating to Biosafety of the genetically modified organism A regulatory agency or an applicant may also request the Authority to review its decision with respect to an activity conducted by the applicant. Any person who is aggrieved by a refusal to grant an approval; the imposition of any conditions on an approval; the revocation, suspension or variation of an approval; a refusal to treat an application as confidential, may, within thirty days of being notified of the relevant decision of the Authority, appeal to the Appeals Board.

REGULATORY AGENCIES The Authority will coordinate all GMO activities. It will be assisted by the regulatory agencies Regulatory agencies exist and draw their mandates from various Acts of Parliament.

RESTORATION AND CESSATION ORDERS Where the Authority has good reason to believe that an approved activity is causing adverse effect to humans and the environment, the Authority is mandated by the Bill to order the person carrying out the activity to either restore the environment to as near as it may be to the state in which it was before the release of a genetically modified organism, or to cease the approved activity.

INSPECTIONS The Minister, in consultation with the Authority has been mandated to appoint Biosafety inspectors, either by name or by title office to carry out inspections. The Bill also gives the inspectors powers to enter premises, take samples and carry out such tests and inspections

FINANCIAL PROVISIONS The Bill sets out provisions for funding including Monies appropriated by parliament Donations and gifts such moneys or assets as may accrue to or vest in the Authority in the course of the exercise of its powers or the performance of its functions under the Act;

MISCELLANEOUS Minister’s powers to make regulations for the better carrying out of the functions of the Act Offences and penalties Offence of withholding information- fine of Ksh 10million or 3years imprisonment Other offences- 1 year imprisonment and a fine of Ksh 1million. Transitional provisions- applications pending before commencement of Act, or approvals granted before the commencement of the Act

CONCLUSION Absence of a Biosafety law exposes the country to regulatory gaps and could be a major weakness undermining the legitimacy and credibility of the national Biosafety system. Enactment of a Biosafety law in Kenya is fundamental to provide adequate legal authority and enforcement. This would provide an enabling environment for modern biotechnology R and D to thrive and at the same time safeguard the country from potential risks posed by the technology

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