Biosafety Regulation in Kenya Prof. Theophilus M. Mutui, PhD Chief Biosafety Officer GM Food / Feed Safety Assessment Training Workshop for Regulators 7 th August 2014, KCB Leadership Center, Nairobi
MISSION & MANDATE To ensure and assure safe development, transfer, handling and use of genetically modified organisms (GMOs) in Kenya Consider and determine GMO applications Strengthen national technical capacities and capabilities for biosafety Promote public awareness on biosafety & biotechnology (11-14 August, 2014) To advise the Government on legislative and other measures related to GMOs
Pro-GM Stakeholders WHAT DOES IT MEAN TO REGULATE GMOS? Anti-GM Stakeholders Responsibility: Objectively evaluate scientific evidence, on a case by case basis and make decisions relating to GMO activities in the best interest of Human & Animal health and Environment
Regulatory Agencies (RAs) 1. Department of Public Health DPH NEMA 8. National Environment Management Authority PCPB 7. Pest Control Products Board 2. Department of Veterinary Services DVS KEBS NBA KWS 6. Kenya Wildlife Service 3. Kenya Bureau of Standards 4. Kenya Plant Health Inspectorate Services KEPHIS KIPI 5. Kenya Industrial Property Institute
BIOSAFETY ACT & REGULATIONS Kenya signed Cartagena Protocol (2000&2003) Biotechnology Development Policy-2006 Biosafety Act No. 2:- 12th February 2009 1. Contained Use (2011) 2. Environmental Release/ Placing on the market (2011) 3. Import, Export and Transit (2011) 4. Regulations for Labeling (2012) 5. Draft: Handling, Storage, Packaging and Transportation
Objectives of Regulations Contained Use / Environmental Release (2011): Ensure that potential adverse effects of GMOs are addressed to protect human health and the environment when conducting experiments in the Lab., GH or CFT (contained use )/ environmental release. Import, Export and Transit (2011): Ensure safe movement of GMOs into and out of Kenya while protecting human health and environment.
Labeling (2012): Regulations To ensure that consumers are aware that food/feed or product is GMO for informed choice To facilitate traceability of GMO products towards enforcement of appropriate management measures
STAGES IN REGULATORY PROCESS Contained-use Environmental Release Commercialization CFT BSL2: Lab. BSL2:Greenhouse DUS, NPT, Variety Release
Application, Review & Approval (Contained use) Application (PI and Team prepare dossier in a prescribed manner) IBC IBC reviews applications and submits to NBA (Arts. 6, 7) Applicati on fees of 170K (Art 7.3) NBA Screens for accuracy & completeness; Send to RAs and Expert Reviewers for Conformance, Risk Assessment; etc. Art 8 Appln. is reviewed by TC of NBA whose recommendations are considered in final decision Decision Document Approval Rejection (Arts. 9, 10, Sch. 4) Regulatory Agency Consideration and grant of Approval NBA acknowledges receipt of application within 30 days from date of receipt NBA takes 90 150 days to communicate decision* (Art 8 (4 & 5)M Sweet Potato took 3yrs! Contained Use Activity
SUMMARY OF APPLICATIONS HANDLED BY NBA SINCE AUGUST, 2010 LAB/GREEN HOUSE TRIALS CONFINED FIELD TRIALS (CFT) ENVIRONM ENTAL RELEASE IMPORTS AND TRANSIT OF GM PDTS APPROVED 16 9 0 28 PENDING 3 1 0 0 TOTAL 19 10 0 28
APPROVED CONFINED FIELD TRIALS (CFT) RESEARCH PROJECTS PROJECT INSTITUTION DATE APPROVED 1. Bt Cotton Project KARI 14 th April, 2007 2. Drought tolerant maize (Event MON 87460) WEMA Project KARI 18 th August, 2010 3. African Bio-fortified Sorghum (ABS ) Project KARI 18 th August, 2011 4. Bt Maize (MON 810) Project KARI 30 th Oct., 2012
APPROVED CFT PROJECTS CONT D PROJECT 5. Bio-fortified cassava ( B-Plus Project) 6. Cassava Mosaic virus resistant cassava( VIRCA Project) INSTITUTI ON KARI KARI DATE APPROVED 18 th August, 2011 18 th Jan., 2011 7. Cassava Brown Streak Disease Resistance (VIRCA Project) KARI 26 th Sept. 2013 8. Gypsophila Project (Colour Change) 9. Cassava Project (CBSD and ACMV) KARI MMUST 3 rd Dec., 2013 10 th March 2014
GM Food Safety Assessment GM Food Safety assessment are: Science based, Comparative Carried out on case-by-case basis Principle of substantial equivalence (SE): GM food is compared to non GM SE is a tool only used as starting point to determine safety of differences between GM food and non GM & not final decision Consideration is given to both intended and unintended effects
Flowchart on Food/Feed Safety Assessment
IMPORT, EXPORT AND TRANSIT INSPECTION AND CLEARANCE Option 1: GMO Free declaration; GMO analysis Certificate from Competent Lab.-SGS GMO status certificate from Competent Authority Option 2: GMO approved by NBA; Approval documents from the Authority Option 3: Consignments on transit; Approval documents from destination country Approval documents from NBA Option 4: Products on NBA Watch List; Stop for Verification. Collect Sample for GMO Analysis
NBA WATCH LIST GM Crop Alfalfa Canola Corn Cotton Papaya Poplar Potato Soybean Squash Sugar Beet Sweet corn Country where crop is cultivated United States Australia/New Zealand, Canada, Chile, United States Argentina, Brazil, Canada, Chile, Colombia, Cuba, Czech Republic, European Union, Honduras, Paraguay, Philippines, Portugal, Romania, Slovakia, Spain, United States, Uruguay Africa: South Africa, Egypt Argentina, Australia/New Zealand, Brazil, China, Colombia, Costa Rica, India, Mexico, Myanmar, Pakistan, Paraguay, United States Africa: Burkina Faso, South Africa, Sudan China, United States China European Union Argentina, Bolivia, Brazil, Canada, Chile, Costa Rica, Mexico, Paraguay, United States, Uruguay Africa: South Africa United States Canada, United States United States, Uruguay Sweet pepper China Tomato China
FLOW CHART-ENVIRONMENTAL RELEASE
Inspection and Monitoring Biosafety inspectors shall be appointed by the Minister on the recommendation of NBA and be gazetted Functions of biosafety inspectors: a) Monitor compliance with the Biosafety Act b) Undertake inspections and submit reports to NBA c) Perform any other functions NBA may deem necessary
Inspection and monitoring Powers of Biosafety Inspectors: a) Enter any premises, facility or property to ascertain compliance with Biosafety Act b) Take equipment or material for which power of entry is being exercised c) Take appropriate samples of material for a d) Carry out tests, inspections and make recordings e) Direct that part of premises remains undisturbed f) Order containment, destruction or testing for GMO g) Require the production of relevant records
Market Surveillance for GM Foods Routine activity for the Authority Buy foodstuffs; supermarkets or open market Obtain official samples from food vendors Testing for detection of GM materials Qualitative and quantitative GMO analysis Unauthorized GM foodstuffs; Issue seizure orders, destroy or impose conditions for use Take legal action
GMO Border Surveillance
Offences and Penalties Any person who manufactures or imports a GMO shall ensure handling, packaging, identification and transportation is done in prescribed manner; Any person who places on the market a GMO without the approval of the Authority; Any person who obstructs or fails to assist Biosafety Inspectors in performing their duties under this Act; Any person who contravenes provisions of the Biosafety Act commits an offense and is liable on conviction to a fine not exceeding Kshs. 20 M ($250,000), imprisonment <10 years, or both
info@biosafetykenya.go.ke mutui@biosafetykenya.go.ke