Implementing biosafety regulation: the role of KEPHIS

1

IMPLEMENTING BIOSAFETY REGULATION: KEPHIS ROLE

CABE, Future Agricultures & Steps Workshop

15-16 Nov 2010

Abed Kagundu (KEPHIS) Ann Kingiri (RIU/ACTS)

GM technology & BiosafetyThe 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

Significance of Regulations

Device to shape governance of technology primarily to promote public interests

Reflected in International Conventions

• IPPC and Codex Alimentarius

• WTO Agreements (SPS and TBT)

• Convention on Biological Diversity– Cartagena Protocol on Biosafety

Reflected in local legislation (Biosafety Act, EMCA Act, KEPHIS Acts etc)

4

BIOSAFETY REGULATION IN KENYA 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 NBCThe 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

Regulatory provisions under Biosafety Act

Approval of GMOs applications and Risk assessment (Part III)Inspection & Monitoring (Part VII)Role of regulatory agencies (Part V)

RA like KEPHIS “shall monitor any activity for which approval has been granted by the NBA to ensure such an activity complies with conditions imposed”

5

6

Then what is KEPHIS role in GMOs regulation?Under the Legal Notice No. 305 of 18th 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 effectsNote: 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

8

LEGAL FRAMEWORKDomestic legislation enforced:

Plant Protection Act (Cap 324)Seed and Plant Varieties Act (Cap 326)Agricultural Produce (Export) Act (Cap 319)Suppression of Noxious Weeds Act (Cap 325)

• All the above are deficient WRT GMOsBiosafety regulations and guidelines of 1998 Biosafety Act, 2009

Supportive reg & guidelinesKEPHIS draft regulations for GMPsAdministrative manuals for handling GMOs requests (NCST)Monitoring & inspections manuals (NCST)

9

KEPHIS GMOs regulatory roleAdvisory role at Institutional Biosafety Committees (IBCs) during review of GMPs applicationsInspection of quarantine/containment/confinement facilities for suitability to GMO work as per biosafety regulations and guidelines and Plant Protection ActApproval of biosafety facilities as closed quarantine and open quarantine sites (Confined Field Trials)Issuance of import permit as stipulated by the NBC/NBA on approvalEnsuring that only approved accessions/GMO products are imported through testing (plant diagnostic labs)Ensuring compliance to conditions stipulated on the NBA permit through monitoring and inspection before importation and after importation

10

MONITORING AND INSPECTIONMonitoring 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

• Containment facilities• Biosafety level 2 Greenhouse and

screenhouse• Confinement facilities

• Field testing sites at Kiboko

12

Biosafety level II Screenhouse-KARI, KENYA

13

Transgenic Sweetpotato Field Trial -KARI Kenya

14

GM Sweetpotato Confined Field Trial Site- KARI,Kenya

Food safety/environmental monitoring role

Main aim is to provide consumer/environ protection; ensure that all foods conform to safety and quality requirementsKEPHIS mainly plays a policy role provided thro ACL analysis of microbiological, chemical/pesticides and physical attributes in food

15

CHALLENGES Managing regulatory process under uncertaintyInstitutional collaboration Different levels of understanding amongst stakeholders/Level of public awareness & education Media hype Inadequate regulatory capacity (this has considerably been addressed)

17

POINTS TO NOTEGMOs products are yet to commercialisedGM crops in the country currently being evaluated under contained/confined facilitiesCommercial release to be preceded by mandatory NPT evaluations to which all plant varieties are subjected to as per Seed and Plant Varieties Act (Cap 326)Regulations to implement the Biosafety Act have not been gazettedThere is need for provision of balanced information to consumers, growers and other stakeholdersUrgent need for information packages and educational programmes for stakeholders in the agricultural & food industry

18

Thank you!