Regulatory and GM Food Safety Assessment Perspectives: Kenya Prof. Theophilus M. Mutui, PhD Chief Biosafety Officer

Transcription

1 Regulatory and GM Food Safety Assessment Perspectives: Kenya Prof. Theophilus M. Mutui, PhD Chief Biosafety Officer HESI Food Allergy and Safety Workshop KICC Nairobi, Kenya, 12 th August 2014

2 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

3 WHAT DOES IT MEAN TO REGULATE Pro-GM Stakeholders 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

4 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

5 BIOSAFETY ACT & REGULATIONS Kenya signed Cartagena Protocol (2000&2003) Biotechnology Development Policy-2006 Biosafety Act No. 2:- 12th February 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

6 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 days to communicate decision* (Art 8 (4 & 5)M Sweet Potato took 3yrs! Contained Use Activity

7 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 PENDING TOTAL

8 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

9 Risk Analysis Objective: identify potential for adverse effects that GM foods may pose to human and animal health Risk Assessment (RA): scientific process to identify sources of potential harm, assesses the likelihood that harm will occur, and consequences if it occurs Risk Management (RM): evaluates which risks identified in RA requires management, selects and implements the plans and actions that are required to ensure the risks are under control Risk Communication (RC) : involves an interactive dialogue between stakeholders, risk assessors and risk managers to actively inform the RA and RM processes

10 Food Safety Risk Analysis Framework Risk Communication Risk Assessment Risk Management Steps (i) Hazard identification (ii) Hazard characterization (iii) Exposure assessment (iv) Risk characterization Risk Analysis = Risk Assessment + Risk Management + Risk Communication

11 Flowchart on Food/Feed Safety Assessment

12 GM Food Safety Assessment Food / Feed Product: Introduced trait Purpose of introduction Is food or feed consumed processed or raw? Molecular characterization: Genetic modification Sequence of inserted genes Expression of inserted genes Gene stability

13 GM Food Safety Assessment Compositional analysis: Analysis results: Macronutrients, Micronutrients, Anti-Nutrients and Secondary Metabolites Crop known to contribute significantly to diet Toxicity: New proteins and mode of action Amino acid sequence similarity to known toxins Acute oral toxicity in validated rodent models Animal feeding studies with whole product

14 GM Food Safety Assessment Allergenicity: Is hypersensitive reaction initiated by immunologic mechanisms caused by allergens Gene source and history of allergenicity Similarity of amino acid sequence to allergens In vitro protein digestion (simulated gastric fluid) Unintended effects: Insertional mutagenesis, Disrupted gene function Production of new proteins, Phenotype changes Changes: Metabolites, Enzymes, Toxins, Genotype

15 Food Safety Assessment Report New product should be substantially equivalent to conventional counterpart A food/feed safety assessment report is compiled and forwarded to TC for review TC report is tabled in BoM for approval or rejection based on safety data provided If approved, the CEO prepares approval documents and inform the applicant

16 FLOW CHART-ENVIRONMENTAL RELEASE

17 Import, Export & Transit:Requirement A person shall not import, export or transit a GMO without written approval from NBA A person importing a GMO must provide evidence of regulatory approval from country of origin A person transiting shall ensure GMO is packaged and transported as per our Law A person transiting or exporting GMO require prior approval by receiving country

18 GMO Border Surveillance

19 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

20 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

21 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

22