Biosafety and Bioethics in Biotechnology

Policy, Advocacy, and Capacity Building

Sylvia Uzochukwu, Nwadiuto (Diuto) Esiobu, Arinze Stanley Okoli, Emeka Godfrey Nwoba, Ezebuiro Nwagbo Christpeace, Charles Oluwaseun Adetunji, Abdulrazak B. Ibrahim, Benjamin Ewa Ubi

• Publisher: CRC Press
• Year: 2022
• Print ISBN: 9781032224169
• eBook ISBN: 9781000550993
• Edition: 1
• Topic: Médecine
• Subtopic: Biotechnologie en médecine

This book covers a range of important topics in biotechnology policy, advocacy and education, bioethics, biosafety regulations for genetically modified organisms and gene-edited products and biotechnology manpower development. Throughout the book, the contributors review biosafety and bioethical guidelines that could enhance adoption of biotechnology in alignment with national priorities and research agendas. They also discuss the importance of current biotechnology policy advocacy, enlightenment and public engagement with stakeholders and policy makers. The book will be useful reference material for scientists and researchers working in the fields of food and agricultural biotechnology, biopharmaceuticals and medical biotechnology, environmental biotechnology, biotechnology policy and advocacy, biotechnology communication and manpower development, biosafety and bioethics, etc.

• Emphasizes recent advances in biotechnology that could ameliorate the high-level global food insecurity through the deployment of the technology in Nigeria
• Provides detailed information on how to domesticate biotechnology and boost training of the biotechnology workforce in the universities and research institutes
• Introduces new frontiers in the area of organizing informal biotechnology capacity building courses and professional certification
• Reviews biosafety and bioethical guidelines that could enhance adoption of biotechnology in alignment with national priorities and research agendas
• Discusses current biotechnology policy advocacy, enlightenment and public engagement with stakeholders and policy makers

Sylvia Uzochukwu, Ph.D., is a Professor of Food Science and Biotechnology, and Director, Biotechnology Centre, Federal University, Oye-Ekiti, Nigeria.

Arinze Stanley Okoli, Ph.D., is an Associate Professor at Genoek – Centre for Biosafety, Universitetet II, Breivika, Tromsoe, Norway.

Nwadiuto (Diuoto) Esiobu, Ph.D., is a Professor of Microbiology and Biotechnology at Florida Atlantic University, Boca Raton, FL, USA, and the President and Founder of Applied Biotech, Inc. and ABINL.

Emeka Godfrey Nwoba, Ph.D., is currently at the Algae Research & Development Centre, Murdoch University, Western Australia.

Christpeace Nwagbo Ezebuiro, Ph.D., is a Project Manager, Renewable Energy Expert and Head of Clean Technology Division at the National Biotechnology Development Agency, Abuja, Nigeria.

Charles Oluwaseun Adetunji, Ph.D., is an Associate Professor of Microbiology and Biotechnology and the Director of Intellectual Property and Technology Transfer, Edo State University Uzairue, Nigeria.

Abdulrazak B. Ibrahim, Ph.D., is a Capacity Development Expert at the Forum for Agricultural Research in Africa (FARA) and Associate Professor of Biochemistry, Ahmadu Bello University, Zaria, Nigeria.

Benjamin Ewa Ubi, Ph.D., is a Professor of Plant Breeding and Biotechnology and Director, Biotechnology Research and Development Centre, Ebonyi State University Abakaliki, Nigeria.

1 Status of Nigeria’s Biosafety Regulation

Rufus Ebegba, Scholastica Bello, and Joy Onwude

National Biosafety Management Agency (NBMA), Federal Ministry of Environment

DOI: 10.1201/9781003179177-1

CONTENTS

• 1.1 Introduction
  • 1.1.1 Mandate, Vision and Mission
  • 1.1.2 Problem Statement and Justification
• 1.2 Evolution of Biosafety Regulation in Nigeria
• 1.3 Essentials of the Nigerian Biosafety System
  • 1.3.1 Risk Analysis
  • 1.3.2 Nigeria’s Biosafety Regulatory Instruments
    • 1.3.2.1 National Biosafety Management Act 2015
    • 1.3.2.2 National Biosafety Regulation 2018
    • 1.3.2.3 National Biosafety Policy 2018
    • 1.3.2.4 National Biosafety Risk Analysis Framework 2018
    • 1.3.2.5 Biosafety Guidelines
    • 1.3.2.6 Biosafety Manuals
  • 1.3.3 National Genetic Modification, Detection and Analysis Laboratory
• 1.4 Goals of the Nigeria Biosafety System
• 1.5 Nigeria’s Biosafety Decisions So Far
  • 1.5.1 Accreditation of Institutes to Carry Out Modern Biotechnology Activities
  • 1.5.2 Approval for Confined Field Trials in Nigeria
  • 1.5.3 Approval for Commercial Release
  • 1.5.4 Approval for Food, Feed and/or Processing (FFP)
  • 1.5.5 Gene Registration
• 1.6 Synergy among Stakeholders for Effective Regulation of Modern Biotechnology and GMOs in Nigeria
  • 1.6.1 Collaborating Organizations in Nigeria with NBMA
    • 1.6.1.1 Foreign/Developmental Partners
    • 1.6.1.2 Ministries, Department and Agencies
    • 1.6.1.3 National Research Institutes
    • 1.6.1.4 Non-Governmental Organizations (NGOs), Civil Society Organizations (CSOs), Professional Organizations, Faith-Based Organizations (FBOs) and Community-Based Organizations (CBOs)
    • 1.6.1.5 Media
  • 1.6.2 Memorandum of Understanding (MoU) with Relevant Regulatory Agencies
• 1.7 The Role of Nigeria in International Biosafety Regulation
• 1.8 New Focus
• 1.9 Regulatory Challenges
• 1.10 Conclusion
• References

1.1 Introduction

Nigeria as a country is endowed with a variety of plant and animal species forming Nigeria’s biodiversity which is in abundance within the country, highly cherished and therefore, needs conservation and sustainable utilization (First National Biodiversity Report, 2001). At the 1992 Earth Summit in Rio de Janeiro, Brazil, world leaders agreed on a comprehensive strategy for “sustainable development” – meeting our needs for health, environment and biodiversity while ensuring that we leave a healthy and viable world for future generations. One of the key agreements adopted at Rio was Convention on Biological Diversity (CBD), which establishes three main goals: the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of the benefits arising from the use of genetic resources (CBD, 1992). Nigeria signed the CBD in 1992 to show commitment to Global Biodiversity conservation (UN, Biosafety Clearing House BCH).

Irrespective of the potential benefits of modern biotechnology, there are concerns that these products have potential adverse effects on human, plant and animal health, biological diversity and the environment. Also, there are several important socio-economic, cultural and ethical issues to be considered in the adoption and use of the products of modern biotechnology. As a result of these concerns, the Cartagena Protocol on Biosafety (CPB) was adopted in Montreal on 29 January 2000 at an extraordinary meeting of the Conference of the Parties to the CBD. The CPB makes provisions to regulate, manage or control risks associated with transfer, handling and use of organisms and derived products resulting from modern biotechnology that may have adverse effects on conservation and sustainable use of biological diversity, taking into account risks to human health, focusing on their transboundary movement (CPB, 200).

Nigeria signed the CPB in 2000 and ratified it in 2003 and subsequently, the Nagoya Kuala Lumpur Supplementary protocol on Liability and Redress to the Cartagena Protocol in Biosafety in 2010 (UN Biosafety Clearing House, BCH). As a signatory to the CBD and CPB, Nigeria is obliged to implement the articles of the CPB and develop its own national regulatory framework for the safe transfer, handling, use and release of genetically modified organisms (GMOs) and products resulting from modern biotechnology. In fulfilment of these international obligations, the Nigerian government signed into Law the National Biosafety Management Agency Act, 2015 on the 18th of April 2015. This Act established the National Biosafety Management Agency (NBMA), charged with the responsibility of providing regulatory framework, institutional and administrative mechanism for safety measures in the application of modern biotechnology and the use and handling of GMOs in Nigeria. This is with a view to preventing any adverse effect on human health, animals, plants and the environment.

The Government of Nigeria, in keeping with the dynamics of global modern technological developments, endorsed the NBMA (amended) Act 2019 in August 2019, which expanded the mandate of NBMA to include emerging biotechnology applications (gene drive, synthetic biology, gene editing) as well as biosecurity.

1.1.1 Mandate, Vision and Mission

The mandate, vision, mission, core values and enabling authority of the NBMA are as follows:

• Mandate: Provision of regulatory framework, institutional and administrative mechanisms for safety measures in the application of modern biotechnology in Nigeria with a view to preventing any adverse effects on human health, animals and the environment.
• Vision: Having in place a holistic, responsive and vibrant National Biosafety System that offers the best of its potentials in the regulation of modern biotechnology activities in Nigeria, with a view to preventing any adverse impact on the conservation and sustainability of biodiversity taking into account risk to human health.
• Mission: To promote the basic tenets of biosafety as enunciated in the Cartagena Protocol on Biosafety and enforce Nigeria National Biosafety Management Agency Act 2015, regulations and guidelines to ensure safe application and use of products of modern biotechnology.
• Core values: The Agency, as the Competent National Authority on Biosafety issues, operates on the following core values: safety to the environment and human health, respect for human dignity, transparency, integrity and professionalism.
• Enabling authority: Established by the National Biosafety Management Agency Act 2015, to provide regulatory framework to adequately safeguard human health and the environment from potential adverse effects, while harnessing the potentials of modern biotechnology and its derivatives, for the benefit of Nigeria.

The Agency is governed by a Board. The day-to-day activities of the Agency are under the direction of the Director General/Chief Executive Officer. The Agency has a staff strength of 353.

1.1.2 Problem Statement and Justification

Modern biotechnology is believed to possess the potentials to help improve food security, promote sustainable use of natural resources and enhance agricultural productivity by introducing resistance to pests and disease without costly purchased inputs; heighten crops’ tolerance to adverse weather and soil conditions; improve the nutritional value of some foods; and enhance the durability of products during harvesting or shipping. However, the use of the techniques of modern biotechnology in agriculture has given rise to ardent debates over the last 30 years about the benefits versus the risks posed by GMOs and their products thereof (James, 2011). Toxicity, allergenicity, pathogenicity, gene flow and effects on non-target organisms are just a few concerns regarding GMOs. It is to this end that biosafety has come to address these concerns. There is need for effective communication of Biosafety Regulation in Nigeria so as to allay the fears of her citizens and equip them with the knowledge of the role of the government in ensuring adequate protection of human health, biodiversity and the environment.

This chapter intends to give an overview of the status of Biosafety Regulation in Nigeria. In this chapter, particular attention will be given to the following objectives:

• To state the various biosafety regulatory instruments developed;
• To give an outline of the biosafety decisions reached;
• To outline the challenges faced by the Agency in the discharge of her duties.

1.2 Evolution of Biosafety Regulation in Nigeria

Nigeria has evolved through various biosafety regulation stages as enumerated in Table 1.1 with dates.

Table 1.1 Evolution of Biosafety Regulation in Nigeria

Regulation Stages	Dates
First National Biosafety Guidelines, under Federal Ministry of Agriculture and Natural Resources	1994
Biodiversity/Biosafety activities under the defunct Federal Environmental Protection Agency (FEPA)	1997
National Biosafety Unit, Federal Ministry of Environment	1999
Second National Biosafety Guidelines, under Federal Ministry of Environment (FMEnv)	2001
Nigeria signed and ratified the Cartagena Protocol on Biosafety	2000, 2003
Development of National Biosafety Framework (NBF)	2002–2006
Development of National Biosafety Policy	2002–2006
Draft Biosafety Bill, among others	2002–2006
N...

Table of contents

• Cover
• Half Title Page
• Series Page
• Title Page
• Copyright Page
• Dedication Page
• Table of Contents
• Foreword
• Preface
• Editors
• Contributors
• Chapter 1 Status of Nigeria’s Biosafety Regulation
• Chapter 2 CRISPR/Cas9: Regulatory Considerations to Ensure Safety of Gene-Edited Products in Nigeria
• Chapter 3 Regulating Gene-Edited Products in Nigeria
• Chapter 4 Emerging Technologies: Can African Regulators Take a Lead on Transgenic Mosquito Regulation?
• Chapter 5 Ethical and Social Aspects of Modern Biotechnology
• Chapter 6 Science Communication in Agricultural Biotechnology and Public Engagement with Stakeholders in Nigeria
• Chapter 7 Biotechnology Development in Nigeria: Meeting Critical Developmental Needs
• Chapter 8 Communicating Scientific Innovations: The Case of Agricultural Biotechnology in Nigeria
• Chapter 9 Current Status of Biotechnology Manpower Development in Nigeria
• Chapter 10 Challenge of Science, Technology, Engineering, and Mathematics (STEM) in Technological Development of Nigeria
• Chapter 11 Capacity Building in Contemporary Biotechnology in Nigeria: History, Impact and Way Forward
• Chapter 12 Outlook on Bioeconomy in Africa: Strategies for Transforming Biotech Knowledge and Technical Base into Skilled Workforce and Productivity
• Index