The advent of modern biotechnology and especially potential for its application in medicine, agriculture, food processing, manufacturing and environmental management was seen as a breakthrough in dealing with problems that face mankind (World Bank, 2008; FAO, 2004).
However, development and application of biotechnology in a safe and sustainable manner remains a subject of considerable debate worldwide.
Concerns, anxiety and fears have been raised about safety and ethical aspects of genetically modified organisms to consumers and the environment .
The only way to balance the potential benefits and risks as well as different concerns is through REGULATION
The recently approved Biosafety Act, 2009 provides for “regulation of activities involving GMOs”
It defines Biosafety as “avoidance of risk to human health & environment, and the conservation of the environ, as a result of use of GMOs”
Previously biosafety regulation was coordinated thro’ NCST via a National Biosafety Committee (NBC) guided by the Regulations and Guidelines of 1998 developed by KARI/NCST. KEPHIS has been a active member of the NBC
The scope of these old regulations:
Facilities fell under four distinct categories (biosafety levels-I,II,III,IV) commensurate with level of risk.
Facilities: laboratories, greenhouse or open quarantine sites/CFTs
Under the Legal Notice No. 305 of 18 th Oct. 1996, KEPHIS is mandated (among others) to:
Regulate the importation and exportation of agricultural, horticultural and forest material through adherence to strict quarantine regulations and procedures (Phytosanitary matters or Plant Health)
Regulates the certification and registration of all seed including GMO seed
To implement the national policy on the introduction and use of genetically modified plants, insects and micro-organisms
Monitor levels of residues of agricultural inputs and their environmental effects
Note: Its mandates advance and embrace the biosecurity agenda with respect to plant health & food safety
Phytosanitary inspections Seed field inspections Seed germination and purity testing Evaluation of new plant varieties Screening for plant pest and disease Soil, water and agrochemical analysis Overview of Biosafety Operations at KEPHIS
Monitoring and Inspection during contained stage & after deliberate release
A rigorous monitoring program prevents problems from occurring during implementation & if a situation of non-compliance does arise, will provide for early detection and prompt remedial action (Biosecurity and emergency response).
Biosafety facilities approved at KARI by KEPHIS