CO-ORDINATION STRUCTURE

A Proposed Co-ordination Structure for Biosafety Regulatory Agencies

Acknowledgement

The coordination structure for regulatory agencies was prepared through a series of consultative meetings. We are grateful for the active participation and cooperation demonstrated by the regulatory agencies during the process of drafting and revising numerous versions of this document. We are particularly thankful to the following members for their technical input and ideas;

• Mr. Abed Kagundu (KEPHIS),
• Mr. Allan Mweke (KEPHIS),
• Mr. Robert Kilonzo (the Department of Public Health),
• Dr. Joyce Thaiya (DVS),
• Dr. Paul Ngaruiya (PCPB),
• Mrs. Margaret Aleke (KEBS),
• Mr. Parkinson Ndonye and Mrs Catherine Mbaisi (NEMA).

We thank members of the Program for Biosafety Systems (PBS) Kenya Advisory Committee for their constructive comments that helped to refine this document.

This work was facilitated technically by PBS and financially supported by the United States Agency for International Development (USAID) through the International Food Policy Research Institute (IFPRI) under the aegis of the PBS Kenya Associate Award.  Their support is highly appreciated. We are also grateful to the National Council for Science and Technology (NCST) and specifically Mr. Harrison Macharia and Ms. Roselida Owuor for supporting the coordination and implementation of PBS activities in Kenya, Dr. Margaret Karembu and Mr. Daniel Otunge (ISAAA AfriCenter) for fine tuning the terms of reference for the regulatory agencies, Dr. Gabrielle Persley (PBS) for her advisory role, Mr. John Komen (PBS) for  commenting  on various drafts of this documents and finally Mr. David Wafula (PBS) for working closely with the regulatory agencies in analyzing and consolidating their inputs and comments.

Introduction

Fostering coordinated and mutually acceptable approaches to decision making among regulatory agencies is one of the critical areas identified within the broader agenda of building and strengthening a functional national biosafety system under the PBS Kenya Associate Award.  PBS is an IFPRI-managed program that supports partner countries in Africa and Asia in the responsible development and safe use of agricultural biotechnology. PBS effectively addresses biosafety through an integrated program of research, capacity development and outreach.

In response, to the need for a coordinated and harmonized approach to biosafety decision making, the National Council for Science and Technology (NCST) and the Program for Biosafety Systems (PBS) initiated the process of facilitating regulatory agencies to delineate their roles and responsibilities.  The key biosafety regulatory agencies including the Department of Veterinary Services (DVS),  Kenya Plant Health Inspectorate Service (KEPHIS), National Environment Management Authority (NEMA), Pest Control Products Board (PCPB), Public Health Department and Kenya Bureau of Standards (KEBS) were asked to develop a coordination structure (document) that outlines their regulatory roles, procedures and decision making mandates.

The following Terms of Reference (TORs) were drafted to guide the agencies on this task. An outline was also drafted to ensure that a standard format is applied by all the agencies.  

Overall task
 
Develop a coordination structure (document) that outlines the regulatory roles, procedures and decision-making mandates of each biosafety regulatory agency.  

 Specific tasks

• Define and harmonize the decision-making process and roles of each regulatory agency in handling introduction, trials and commercial release of GM plants.
• Define and demarcate the decision-making process and roles of each regulatory agency in handling introduction, trials and commercial release of transgenic animals and microorganisms
• Define and harmonize the decision-making boundaries and roles of each regulatory agency in handling food and feed commodity imports and exports including food aid.
• Define and harmonize the decision-making boundaries and roles of each regulatory agency in the approval of biopesticides, biofertilizers, veterinary inputs and products.

This document has been prepared through a number of consultative meetings in line with the above ToRs.

The Biosafety Regulatory System in Kenya