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The Biosafety Regulations : towards implementation of Biosafety Act., 2009

The Biosafety Regulations : towards implementation of Biosafety Act., 2009. Prof. Dorington O. Ogoyi Director, Technical Services National Biosafety Authority Presented during Biosafety Workshop Mombasa (18 t – 19 th June,2013). Vision. A World Class Biosafety Agency. Mission.

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The Biosafety Regulations : towards implementation of Biosafety Act., 2009

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  1. The Biosafety Regulations: towards implementation of Biosafety Act., 2009 Prof. Dorington O. Ogoyi Director, Technical Services National Biosafety Authority Presented during BiosafetyWorkshop Mombasa (18t – 19th June,2013)

  2. Vision A World Class Biosafety Agency

  3. Mission To ensure and assure safe development, transfer, handling and use of genetically modified organisms in Kenya

  4. BIOSAFETY REGULATIONS • The Law provided for gazzetment of regulations that would be important for the implementation of the Biosafety Act 2009; • To date 4 regulations have been gazetted: Regulations for; • Contained Use • Environmental Release • Import, Export and Transit • Regulations for Labeling (2012)

  5. Biosafety (Contained Use) Regulations Context and Scope • These regulations cover activities involving GMOs under containment and confinement • They are typically applied during research on GMOs (LAB, Green house, Screen house CFT) Objective (Art. 3) • The objective of this Regulation is to ensure that potential adverse effects of genetically modified organism are addressed to protect human health and the environment when conducting contained use.

  6. Contained Use: Requirements • A person shall not conduct any activity involving GMOs without written approval from the Authority (Biosafety Act, 2009, Art. 18) • A person shall not undertake contained use without the written approval of the Authority (Art. 7. (1) • Such activity must be carried out within or in collaboration with a research institution • The research institution carrying out such activity must establish Institutional Biosafety committee

  7. INSTITUTIONAL BIOSAFETY COMMITTEE • Composition: • Biosafety Officer • Scientist in a relevant field • Representative in of technical staff • Representative of laboratory management • Representative of the community • Relevant regulatory agency

  8. Functions of IBC • To facilitate reparation of application together • Advise Institution on Biosafety issues • Assist institutions in monitoring mechanism for risk assessment & management • Ensure compliance with approval conditions • Review and ascertain suitability of containment (Physical & Biological) • Advise institution & PI on mitigation measures in case of accident

  9. Contained use: Requirements • For contained use (laboratory, greenhouse or screen house: • NBA in consultation with relevant regulatory Authority shall assess the suitability of facility • NBA together with regulatory Authority shall establish the containment level (Schedule2) • For confined field trials- Appropriate measures to be determined through procedures developed by NBA and regulatory agencies

  10. Handling Applications • Applications are made to the Authority in a prescribed form • Upon receiving an application, the Authority will screen the application for completeness. • Screening involves both administrative as well as technical assessment of the form to ensure that all the relevant information needed to make a decision is availed • If an application is complete, the Authority acknowledges the application, in writing.

  11. Handling applications • Where an application is not complete, the Authority must inform the applicant and request for additional information from the applicant • Every application must be acknowledged within thirty days of receipt of the application • Once an acknowledgement has been issued, the clock starts running. Every application must be determined within 150 days of receipt of the application

  12. Screening for completeness NBA shall screen the application to confirm: • That application conforms to the regulation • The accuracy and completeness of the information • The risk assessment submitted by applicant • The level of contained use; • Suitability of containement, other protective measures, waste management, contingency measures

  13. Approvals • An approval with conditions shall be as per the form in fourth schedule • Approval shall be for the period of activity indicated in the application • A grantee shall submit quarterly reports on the progress • A grantee may request for extension /modification of contained use • NBA shall make decisions on the request in 30 days (if no RA is required) and within 150days (if RA required)

  14. Other Provisions • Suspension/Revocation of approval (Art. 11) • Handling of New Information (Art. 12) • Contingency Plans/Emergency Measures (Art. 13) • Miscellaneous (Register of Decisions, BCH, CBI) • Offences, Schedules “A person who contravenes any provisions of the regulations……………” a fine not exceeding KSh 20 million, imprisonment of ten years or both”

  15. Biosafety (Envir. Release) Regulations Context and Scope • These regulations cover activities involving release of GMOs into environment; placing on market • Typically apply during commercialization Objective (Art. 3) • The objective of these Regulations is to ensure that potential adverse effects of genetically modified organisms are addressed to protect human health and the environment when conducting environmental release.

  16. Environmental Release: Requirements • A person shall not conduct any activity involving GMOs without written approval from the Authority (Biosafety Act, 2009, Art. 18) • A person shall not make an environmental release or place on market a GMO without the written approval of the Authority.(Art. 5(1); 6 (1) • An application for environmental release/placing on market shall be made to the Authority … (in a prescribed manner with KShs 850,000 as fees)

  17. FLOW CHART-ENVIRONMENTAL RELEASE

  18. Biosafety (Import, Export & Transit) Regulations Context and Scope • These regulations cover activities involving importation into, exportation out of and movement of GMOs through Kenya • Could touch on aspects of release or placing on market in which case Regulations on Release apply Objective (Art. 3) • The objective of these Regulations is to ensure safe movement of genetically modified organisms into and out of Kenya while protecting human health and the environment

  19. Import, Export & Transit: Requirements • A person shall not conduct any activity involving GMOs without written approval from the Authority (Biosafety Act, 2009, Art. 18) • A person wishing to import, export or transit a GMO shall apply for and obtain written approval from the Authority (Arts. 4(1); 5(1) & 6 (1) • A person transiting shall ensure GMO is packaged and transported as per Kenyan Laws • Transit require prior approval by the receiving country

  20. LABELING REGULATIONS, 2012 • Objective: • To ensure that consummers are aware that food/feed or product is GMO for informed choice • To facilitate traceability of GMO products towards enforcement of appropriate management measures

  21. Provisions of the labelling regulation • Application: foods consisting of GMO or derived from GMO • Exemptions: Where GMO is bellow 1% threshold level; Highly refined foods devoid of GMO, food additive, food intended for consumption and sold from food premises or vendors • Labelling requirement • Monitoring inspection and compliance

  22. APPROVALS • Import/export products • Contained use: (Laboratory, green house, CFT)- • Target crops in CFT: cotton maize, sorghum, cassava • Animals: Knock out mice, transgene cattle (trypanotolerant, Improved vaccine) • Environmental release: Anticipated in 2014

  23. APPLICATIONS SINCE AUGUST, 2010 Target crops in CFT: cotton maize, sorghum, cassava

  24. Monitoring and Evaluation • Quarterly reports expected from approved projects • Monitoring In consultation with regulatory agencies • Empowerment of Biosafety inspectors • Monitor compliance with the act • Undertake inspections

  25. MONITORING AND INSPECTION VISIT TO ILRI FACILITIES AND GMO PROJECTS Dr. Leena Triphathi and Ephy Khaemba takes NBA, KEPHIS & DVS Inspection Team through the Greenhouse where some GM Plants are growing. VISIT MADE ON 30TH APRIL 2012

  26. INSPECTION EXERCISE NEXT TO LARGE ANIMAL FACILITY IN ILRI NAIROBI CAMPUS Dr. James Wambulwa, the Animal Project Trial Manager and Consultant at ILRI With the NBA, DVS and KEPHIS biosafety inspection team

  27. Thank You For more information: Website: www.biosafetykenya.go.ke E-mail: info@biosafetykenya.go.ke

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