Regulatory Frameworks for Animal Biotechnology in Africa Workshop

    July 28, 2022-July 29, 2022
    Movenpick Hotel & Residences
    Nairobi, Kenya


The development and use of genetically engineered (GE) animals have lagged the commercialization of genetically engineered plants. Partly as a result of this, regulatory systems for addressing the pre-market safety assessment and commercial approval of GE animals and derived products are less well developed than with counterpart systems for GE crop plants, resulting in significant uncertainties that have adverse impacts on both innovation and trade. Supported by a grant from the USDA FAS New Technology and Production Division, the Agriculture & Food Systems Institute (AFSI), Acceligen, and the International Service for the Acquisition of Agri-biotech Applications (ISAAA) AfriCenter co-organized a capacity building workshop in Nairobi to assist in the development of the necessary technical and regulatory frameworks to allow for commercialization and trade in the products of animal biotechnology.

Engaging with regulators and experts in African countries that are currently developing GE animals and, in parallel, associated regulatory frameworks, this workshop introduced key concepts, starting with the problem formulation methodology, which allows participants to articulate their environmental and food safety protection goals and follow a logical process for identifying how GE animals can be assessed to ensure that their use does not lead to adverse outcomes for human health or the environment.



Day 1: July 28, 2022 (Morning - Open Session for All Interested Persons)

Chair: Margaret Karembu

8:00 am

Welcome Coffee

8:30 am

Meeting Welcome

Dr. Martin Mwirigi, Kenya Agricultural and Livestock Research Organization (KALRO)

8:50 am

Keynote: Animal Biotechnology for Africa

Jimmy Smith, Director General, International Livestock Research Institute (ILRI)

9:10 am

Biosafety for Animal Biotechnology and Gene Editing in Kenya and Nigeria

Dr. Roy Mugiira, Acting CEO, National Biosafety Authority, Kenya

Dr. Rufus Ebegba, Director General/CEO, National Biosafety Management Agency, Nigeria

10:00 am

Coffee Break

10:30 am

Biosafety for Animal Biotechnology and Gene Editing in Brazil and Argentina

Prof. Fernando Garcia, Professor, Universidade Estadual Paulista & Member, National Biosafety Technical Commission (CTNBio), Ministry of Science and Technology, Brazil

Dr. Martin Lema, Adjunct Professor in Biotechnology, Quilmes National University Argentina (Virtual)

11:30 am

Moderated Panel Discussion to Address Similarities and Differences between the Four Systems

12:30 pm


Day 1: July 28, 2022 (Afternoon - Invited Participants Only)

Chair: Jose Fernando Garcia

1:30 pm

Introduction to the Format for the Remainder of the Workshop

1:40 pm

Presentation of Previous Workshop and Main Recommendations

Dr, Margaret Karembu, Director, ISAAA AfriCenter

2:10 pm

Presentation of Case Study: Technical Introduction

Dr. Tad Sonstegard, Chief Executive Officer, Acceligen

2:45 pm

Coffee Break

3:00 pm

Discussion of Case Study: CRISPR-Cas Gene Editing

4:00 pm

Report Out from the Groups

Day 2: July 29, 2022 (Morning - Invited Participants Only)

Chair: Carl Ramage

8:00 am

Welcome Coffee

8:30 am

Potential for Animal Biotechnology

Christian Keambou Tiambo, Scientist, CTLGH/ILRI Livestock Genetics

9:15 am

Problem Formulation

Dr. Rachel Melnick, Senior Manager – Scientific Programs, Agriculture & Food Systems Institute

9:45 am

Discussion of Case Study: Problem Formulation

10:15 am

Coffee Break

10:30 am

General Overview of Risk Assessment

Dr. Carl Ramage, Rautaki Solutions

11:00 am

Discussion of Case Study: Risk Assessment

12:00 pm

Report Out from the Breakout Groups

12:30 pm


Day 2: July 29, 2022 (Afternoon - Invited Participants Only)

Chair: Rachel Melnick and Margaret Karembu

1:30 pm

African Union Perspectives on Animal Biotechnology

Dr. Mary Mbole-Kariuki, Technology and Innovations Expert, African Union, International Bureau for Animal Resources (AU-IBAR)

2:00 pm

Closing Session: Conclusion of the Case Study

Presentations from the Breakout Groups

3:00 pm

Closing and Thanks

Dr. Roy Mugiira, Chief Executive Officer, Kenya Biosafety Authority