2nd NATIONAL BIOSAFETY CONFERENCE 5- 9th AUGUST, 2013

KENYATTA INTERNATIONAL CONVENTION CENTRE (KICC), NAIROBI, KENYA

Theme: Biosafety Advocacy for realization of Vision 2030

Organized by

NATIONAL BIOSAFETY AUTHORITY

Pre-Conference Courses Program August 5 - 6, 2013

Date

Time 08:00 08:30 08:30 13:00 14:00 - 17:30

Room

Pre-Conference Course Registration

Course Presenter/s NBA Secretariat Prof. Edward Nguu Prof. D. Ogoyi Dr. Kiiyukia Ciira Mr. Charles M. Mburu

Aberdares

Biotechnology and Biosafety Regulatory Framework in Kenya Emergency Responses Systems, Personal Protective Equipment and Occupational Health & Safety Biosafety Levels. Detection and Surveillance of GMOs Decontamination and Waste handling Food and Feed Safety Assessment and Standards Transport of Biological Materials Registration

Aberdares

Monday 5 August 2013

08:30 -13:00

Lenana

th

Mr. Abed Kagundu Mr. George Ngundo Ms. Damaris Matoke Ms. Milka Mwangi Margaret Aleke Prof. Theophilus Mutui Juma Bonventure Nicholas Mwikwabe NBA Secretariat Dr. M. Wach Mr. Josphat Muchiri Ms. Julia Njagi Mr. Thomas Bwana Ms. Ephy Khaemba Ms. Sylvia Wanjiru Dr. Juma Bonventure Dr. Nicholas Mwikwabe Ms. Cecilia Rumberia Mr. Albert Bunyasi Dr. David Mburu Eng. Josphat Wamburu

14:00 - 17:30 08:30- 13:00 14:00 - 17:30 08:00 08:30 08:30 13:00

Lenana Taifa Taifa

Aberdares

14:00 - 17:30 Tuesday 6 August 2012 08:30 -13:00 14:00 - 17:30

Aberdares Lenana Lenana

Environmental Risk Assessment of GM Crops: Case studies on non-target Organisms Developing Institutional Research Compliance Committees Transport of Biological Materials (continuation) Bioethics, Biosecurity and Dual Use Research of concern Design, Construction & Maintenance of High Biocontainment Facilities. Design & Maintenance of Isolation Facilities Biosafety Cabinets, Fume Hoods & Clean Benches

th

08:30- 13:00

Taifa

14:00- 17:30

Taifa

Mr. Gabriel Okondo Ms. Beth Njaramba

Feedback forms should be filled after every course

PRE- CONFERENCE COURSES OBJECTIVES 1.

BIOTECHNOLOGY AND BIOSAFETY REGULATORY FRAMEWORK IN KENYA Prof. Nguu and Prof. Ogoyi Objectives To equip participants with basic facts on biotechnology development and its potential applications. To highlight key biosafety concerns on GM development and applications To enlighten participants on current status regulatory framework in Kenya Contents The development of modern biotechnology Key concerns on use of modern biotechnology Biosafety Law: Alignments to International Conventions Operationalization of Biosafety Regulatory Framework in Kenya: Where are we?

2. INTRODUCTION TO EMERGENCY RESPONSE SYSTEM, PPE AND OCCUPATIONAL HEALTH AND SAFETY Dr. Kiiyukia and Mr. Charles M. Mburu Objective: To summarize the general elements of a health and safety program including emergency preparedness and use of PPE in workplaces. Emergency preparedness to deal with biohazards, fire and other related accidents. To develop programs to deal with their workplace safety specific needs.

a) Occupational health and safety: Identify and characterize workplace hazards Assess risks associated with biohazards Evaluate precautions and preparedness of GMO Identify correct processes and procedures of controlling those hazards associated with GMFs. Investigation and inspection techniques of accidents and near misses Reduce incidents, accident and injury reporting procedures Planning and budget process elements that affect the OSH program. Program overview to control and manage hazardous materials.

b) Emergency preparedness To identify and describe ethical standards for the profession of emergency management of biohazards. To define and critique definitions of bio-disaster To discuss about the biohazards emergency preparedness To discuss the fire hazards emergency preparedness To discuss and debate hazard-specific and all-hazard emergency approaches to disaster. To describe and critique the comprehensive emergency management approach. To assess the future of emergency management policy and programs of biohazards c) The personal protective equipment Explain the importance of wearing Personal Protective Equipment (PPE) Types of PPE Identify PPE Responsibilities: management to select PPE appropriately to task and to require its use, Employees to use selected PPE consistently and correctly Identify some of the uses and limitations of protection provided by specific types of PPE Focusing on common examples of eye/face, head, body, foot, and hand protection Explain the importance of assuring good fit and how to inspect, clean, and maintain PPE Appropriate PPE for handling the bio-hazardous materials

3. BIOSAFETY LEVELS Mr. AbedKagundu Objectives: To carry out a comprehensive analysis of a proposed GM activity to ascertain its safety to human health and the environment.

Content: Determine the nature of the DNA sequences to be transferred, donor organism of the insert, pathogenicity of the GMO and potential hazards. Risk assessment determines the containment level/Biosafety level Classification of the contained-use levels

4. DETECTION METHODS FOR GENETICALLY MODIFIED ORGANISMS Mr. George Ngundo Objectives: The aim of GMO testing is to mitigate the risk of unapproved GM seeds being released in the Kenyan environment.

Content: Sampling methods and sample preparation: Grinding and DNA Extraction Lateral strip test Qualitative and Quantitative PCR tests Interpreting and Reporting Test Results 5. DECONTAMINATION AND WASTE HANDLING Ms. Damaris Matoke Muhia and Ms. Milka Mwangi Objectives: To train participants on key waste management processes To explain on the importance of environmental management To enlighten participants on waste regulations in Kenya Content: Waste definitions and characteristics Train on various waste categories and management processes Guidelines for hazardous waste disinfection, decontamination and disposal Create awareness on biological waste management regulations in Kenya Risks associated with irresponsible waste handling Environmental Management Coordination Act; EMCA 1999

6. STANDARDS FOR FOOD AND FEED SAFETY Ms. Margaret Aleke Objective: Create awareness on food/feed safety standards Content: Create awareness of standards for food and feed derived from recombinant-DNA Create awareness on methods for analysis of foods derived from recombinant DNA

7. FOOD AND FEED SAFETY ASSESSMENT (RISK ANALYSIS) Dr. Allan Liavoga Objective: Create understanding of food and feed safety assessment Content: Explain risk analysis in food and feed Define food and feed safety; and food safety assessment Explain the different approaches for food and feed safety assessment in conventional foods and feed derived from recombinant DNA materials.

8. TRANSPORT OF DANGEROUS GOODS TRAINING Dr. Juma Bonventure and Dr. Nicholas Mwikwabe Objectives The objective of the training is to equip the trainees with the requirements of shipping of dangerous goods as spelled out by the UN, IATA and ICAO as a requirement. The training will be hands own and will be divided into 6 modules. It will be organized into lectures, exercises and assessments. There will be a pre and post-assessment and the successful candidates will be awarded a two years certificate for packaging documenting and shipping dangerous goods as per the internal regulations referred above. Content Module I: Terms Used for Shipping Module II: Classification of Infectious Substances Module III: Packaging of Infectious Substances Module IV: Labeling and Marking Packages Module V: Shipping Documentation Module VI: Shipping with dry ice Module VII: FAQ and tools Final Assessment Certificate of Successful Completion

TUESDAY, 6TH AUGUST 2013 9. ENVIRONMENTAL RISK ASSESSMENT OF GM CROPS: CASE STUDIES ON NON-TARGET ORGANISMS Dr. Michael Wach, Mr. Josphat Muchiri, Ms. Julia Njagi and Mr. Thomas Bwana Objectives To provide participants with an understanding of the principles of environmental risk assessment of GM crops.

To highlight the use of laboratory and field tests in the assessment of risks to nontarget organisms (NTOs). To use case studies to provide hands-on experience in the risk assessment of insectresistant crops.

Contents Key Considerations in the Environmental Risk Assessment of GM Crops Assessment of Impacts to Herbivorous Insects Assessment of Impacts to Beneficial Insects Use of Field Observations in NTO Risk Assessment Small group exercise--Insect-resistant Crop Case Studies

10. DEVELOPING INSTITUTIONAL RESEARCH COMPLIANCE COMMITTEES

Ms. Ephy Khaemba and Ms.Sylvia Wanjiru Objectives To make participants aware of the legal requirements to establish IBCs before embarking on any genetic modification work. Content Composition Functions SOPs / Biosafety Manual

11. BIOETHICS, BIOSECURITY AND DUAL-USE RESEARCH OF CONCERN Ms. Cecilia Rumberia and Mr. Albert Bunyasi Bioethics Objectives The purpose of this course is to provide students with an introduction to the historical and theoretical foundations of bioethics. To present the basic concepts, principles, and elements of bioethics Content The history and development of key international institutions and regulatory documents, pivotal policies, theoretical frameworks informing international bioethics and research ethics, and case studies of specific areas in international bioethics. Describe the ethical responsibilities for individuals working with infectious disease agents in the laboratory. Outline the ethical issues that concern biosafety and biosecurity Discuss codes of conduct for scientists Identify key international codes and conventions in relation to the safe and ethical use of biological sciences

Biosecurity Objectives Develop awareness and understanding of the concepts of biosafety and biosecurity, and its relevance to biosecurity within the laboratory. Develop knowledge of approaches to the conduct of biosafety and biosecurity risk assessments, and be able to provide strategies to appropriately manage these risks. Dual use in research Objectives Create awareness on the historical and regulatory perspective of Dual Use Research of Concern Develop awareness and understanding of a range of dual-use conundrums and dilemmas that arise due to the impact of science and technology on society; Develop awareness and understanding of the ethical, legal and social relevance of dual-use biosecurity Create an understanding of the regulations governing life science research. Familiarize on the Dual Use Research (DURC) criteria. Steps by the Institution to address the issue of DURC.

12. DESIGN, CONSTRUCTION AND MANAGEMENT OF HIGH BIO-CONTAINMENT FACILITIES Dr. David Mburu Objectives To identify factors that governs the design of a high bio-containment facility. To summarize the roles of key professionals involved in setting up a BSL3 laboratory. To outline the significance of the Heating, Ventilation and Air Conditioning (HVAC) system in biosafety. To reinforce the central role of the Building Management System (BMS) as the nerve centre for a BSL3 facility. To present an operational strategy cognizant with the industry optimal. Content Design consideration Project management Builders requirements Laboratory services matrix HVAC system BMS consideration Facility management 13. DESIGN AND MAINTENANCE OF ISOLATION FACILITIES Eng. Josphat Wamburu Objectives To identify factors that governs the design and maintenance of isolation.

Content Engineering Interventions in IPC (Infection prevention& Control) Design & Maintenance of Contact Isolation Facilities. Design & Maintenance of air-borne Infection Isolation Facilities

14. BIOSAFETY CABINETS, FUME HOODS & CLEAN BENCHES Mr. Gabriel Okondo and Ms. Beth Njaramba Objectives To discuss different types of Biological Safety Cabinets (BSCs) and their applications Content Selection limitations of BSCs and their application Proper Use of BSCs HEPA Filters : How they work Decontamination and Annual Certification per NSF Std 49, EN Std, etc.