GUIDE TO BIOSAFETY ACT & THE PROPOSED REGULATIONS

May 29th 2009.

OVERVIEW OF THE KENYA BIOSAFETY ACT, 2009

The Biosafety, Act 2009, was approved by his Excellency the President of the republic of Kenya in February 2009. The Act lays down legal and institutional frameworks for governing modern biotechnology in the country. It has been cautiously developed to ensure that Kenya maximizes the benefits of modern biotechnology while safeguarding against any potential risks. It has been developed in line with the 41 articles of the Cartagena protocol. The process of developing and reviewing the Act has been consultative. 

Kenya has regulatory agencies in place which will be enhanced to regulate modern biotechnology activities. The functions of the proposed National Biosafety Authority are well articulated in the Act and do not include undertaking research but will coordinate research.

Currently issues on modern biotechnology activities are handled by the National Biosafety Committee as an interim measure until the biosafety law is implemented.  The National Biosafety Committee executes its activities under the National Council for Science and Technology (NCST). It comprises of 18 members who are drawn from government ministries, government regulatory agencies, Consumer Information Network, Kenya National Federation of Agricultural Producers (KENFAP) and industrialists....more

1. a)    Scope of the Act

The Act takes cognizance of the various pieces of legislation that are undertaking biotechnology activities. These pieces of legislation have, in some, established various Authorities that carry the day to day functions under the said legislation. The Act therefore instead of having the existing legislation repealed  or amended ,it recognizes the existence of the said legislation and it is for this reason that section 3 of the Biosafety Act that the provisions under the Biosafety Act will be in addition to those under the existing legislation.

b)        Contained Use

The Act covers contained use of GMO's, notwithstanding the exemption set forth in the Cartagena Protocol concerning transboundary movements of GMO’s destined for contained use, because of the importance of contained use as part of the regulatory structure. In addition, it should be noted that the contained use provisions set forth in the Act also would apply to GMO’s used in containment for pharmaceutical development unless specifically stated otherwise. In effect, while separate specific legislation normally is used to deal with clinical trials, product approvals and import of pharmaceutical products, contained use regulations generally cover all laboratory work with GMO’s, even if the substances will ultimately be used for pharmaceuticals products.

c)         Performance Standards for Contained Use

 Kenya has already put in place detailed regulations for laboratories, etc. that would apply to contained use activities involving GMO’s. These regulations are in accordance with international standards. These same performance standards will be used as the criteria for approving any facility seeking to conduct activities involving GMO’s under simplified procedures.

d)      Biosafety Regulations

The Minister responsible for Science and Technology  may, in consultation with the National Biosafety Authority, make regulations for the better carrying into effect the provisions of the Act, and in particular for prescribing:

• anything required by this Act to be prescribed;
• procedures for conducting contained use activities involving genetically modified organisms;
• procedures for release of genetically modified organisms into the environment;
• procedures for importation and exportation of genetically modified organisms;
• procedures for genetically modified organisms in transit;
• procedure for handling, packaging, identification and transportation labelling of genetically modified organisms;
• forms to be used for applications for approvals;
• schedules of fees to cover administrative costs of processing applications and notices;

 2.     The establishment of the Authority.

a) The National Biosafety Authority

The National Biosafety Authority will be a body corporate. The Authority may either generally or in any particular case delegate to any committee of the board or any other member, officer, employee or agent of the authority the exercise of any of the powers of authority under the act.

b)        Functions of the Authority.

The Authority has the following functions;

c. Public Awareness and Participation

The Act promotes and facilitates public awareness, education and participation concerning the safe transfer, handling, and use of GMO’s in relation to the conservation and sustainable use of biological diversity, taking also into account risks to human health. Approach of promoting transparency, education and awareness are seen through publication of final decisions on all intentional introductions into the environment, as well as any compliance matters involving cases of material non-compliance. It allows for direct public participation in decision-making on any regulation proposed under the authority of this Act, any application for placing a GMO on the market, and any petition to exempt GMO’s or activities from authorization requirements.