Speech By The Director-General (NAFDAC) At a workshop on Chemical Security and Vulnerability Assessment, Mitigation, and Chemical Industry Outreach for Chemical Industry Professionals in Nigeria

Protocol

Distinguished Guests

Ladies and Gentlemen

1. It is indeed a great pleasure and an honour to welcome you all to this workshop on Chemical Security and Vulnerability Assessment, Mitigation, and Chemical Industry Outreach for Chemical Industry Professionals in Nigeria.
2. This workshop organised by the United States Department of State’s Chemical Security Program (CSP) in collaboration with their implementing partner, Oak ridge National Laboratories (ORNL) and the National Agency for Food and Drug Administration and Control (NAFDAC) is aimed at providing deeper understanding of security risk assessment and security systems. The crucial role of adequate regulations, industries outreach and law enforcement in increasing chemical security in Nigeria will also be explored.
3. The objective of the workshop is apt considering the inundate threat of chemical terrorism and also augurs well with the current focus of the NAFDAC management to bring the Agency’s regulatory activities in line with international best practices.
4. NAFDAC was established by Decree No. 15 of 1993 as amended by Decree No. 19 of 1999, now NAFDAC Act Cap N1 Laws of the Federation of Nigeria (LFN) 2004 to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of Food, Drugs, Cosmetics, Medical Devices, Packaged Water, Chemicals and Detergents (collectively known as regulated products).
5. The vision of the agency is to safeguard public health through ensuring that only the right quality products are manufactured, imported, exported, advertised, distributed, sold and used in Nigeria.
6. The agency has put in place various strategies to accomplish this task and these strategies are embedded within the functions of four service directorates, ten technical directorates and seven Zonal directorates. The directorates are:
   1. Admin & Human Resources Management Directorate: Responsible for managing human and material resources to promote efficiency and effective operational environment.
   2. Finance & Accounts Directorate: Responsible for the day to day administration of financial and accounting functions of the Agency in line with the provisions of the Financial Regulations, Fiscal Responsibility Act, Procurement Act, 2007.
   3. Legal Services Directorate: Legal Services, prosecution of criminal and defending of court cases, vetting of legal documents and legal advising.
   4. Planning, Research & Statistics Directorate: Responsible for planning, researching, collecting, collating, storing and retrieving of data as well as documenting the activities and reports of the Agency.
   5. Registration and Regulatory Affairs Directorate: Leads timely and transparent registration process driven by effective regulations that result in granting of marketing authorisation to regulated products of highest quality standards.
   6. Chemical Evaluation & Research Directorate: Grant authorization for the import of chemicals and inspect storage facility to ensure safety and security standard in management of chemical and hazardous substances.
   7. Food Safety and Applied Nutrition Directorate: Support food safety programmes by ensuring food facilities adhere to good manufacturing practice (GMP) that can sustain quality food product that is safe for human consumption.
   8. Drug and Evaluation Directorate: Develop, operate and continually improve QMS to ensure a robust and effective Inspection operation that will guarantee safe, effective and good quality medicinal products, cosmetics & allied products.
   9. Narcotics & Controlled Substances Directorate: Grant authorization for the import of narcotic drugs and psychotropic substances as well as other controlled substances (precursor chemicals inclusive). Collaborate with other stakeholders in measures to stem drug abuse
   10. Veterinary Medicines & Allied Products Directorate: Regulate and control Veterinary Medicines, Veterinary products, Pesticides and Agro-chemicals.
   11. Port Inspectorate Directorate: Lead port operation and Control the channels through which regulated products are imported and exported.
   12. Pharmacovigilance & Post Marketing Surveillance Directorate: Enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
   13. Laboratory Services Directorate: Conduct appropriate tests and ensure compliance with standard specifications. Work with Pharmacovigilance & Post Marketing Surveillance Directorate on continuous monitoring of quality of medicines and wholesomeness of foods.
   14. Investigation & Enforcement Directorate: Enforce and ensure compliance with all regulatory requirements.
   15. Zonal Directorates/Federal Capital Territory Office: There are seven directors overseeing the activities of the agency in the six geopolitical zones and the Federal Capital Territory. They operate as mini NAFDAC in their zones.
7. Five of the technical directorates are in one way or the other involved in some aspect of regulation of Chemicals. Narcotics & Controlled Substances Directorate regulate and control all precursor chemicals listed in Tables I and II of the 1988 United Nations Convention Against Illicit Traffic  in Narcotic Drugs and Psychotropic Substances. These include Ephedrine, Pseudoephedrine, Piperonal, Acetic Anhydride Sulphuric Acid, Hydrochloric Acid, Toluene, Potassium Permanganate. Veterinary Medicines & Allied Products Directorate regulate and guide stakeholders on pesticides and agro-chemicals. Port Inspectorate Directorate conducts the inspection and clearance of all imported/exported chemicals, and Laboratory Services Directorate conduct tests and pronounces on the quality of chemicals
8. Chemical Evaluation and Research Directorate has the mandate to safeguard public health by ensuring that only the right quality chemicals are manufactured, imported, exported, distributed, sold and used in Nigeria. The Directorate is structured into 4 Divisions: Chemical Import Control Division, Agro-Chemicals and Controlled Chemicals Division, Chemical Monitoring & Risk Assessment Division and Chemical Research and Review Division.

The directorate ensures availability of chemicals to eligible companies through prompt issuance of permits to import and clear Industrial and Restricted Chemicals. The process of obtaining import permits is electronic and this can be done on the Nigeria Single Window Portal website. (www.trade.gov.ng/nafdac)

The directorate has put in place effective regulations and guidelines for sound chemical management in Nigeria. This is achieved by ensuring proper utilization of chemicals in a manner that reduces risk to health and environment and advocating for use of chemicals that are less harmful and hazardous.

The directorate collaborates with other Ministries, Departments and Agencies (MDAs) like Office of the National Security Adviser, Ministry of Environment, Office of the Secretary to Federal Government and others on life cycle management of chemicals.

Furthermore, the directorate ensures conformity to international conventions and protocols like the Chemical Weapons Convention, Montreal Protocol, Stockholm Convention, and Basel Convention for Chemicals and development of   policies   and   science-based advice and information on chemical risk assessment.

The directorate also investigate and inspect production and storage premises thereby promoting standards and regulations on the handling of chemicals.

9. The use of chemicals has increased geometrically in the past years in Nigeria. This has also raised issues of misuse and hence concerns for chemical safety and security threats. This has placed a remarkable focus on the need for improved collaboration, capacity building, and enforcement with corresponding effective and efficient regulations to achieve the desired outcome.
10. Increase in local manufacturing and industrialization of the economy has led to growth in the Chemical Industry in Nigeria. The safe and secure management of Chemicals is therefore an issue of growing importance that requires a collaborative effort amongst regulators, law enforcement agencies and the industries.
11. The proliferation of Drug Abuse and Chemicals in terrorism is recognized as a serious National challenge. The nation is concerned with the possibility of terrorists or criminal groups acquiring chemicals for destructive purposes. It is in this environment of heightened concern that NAFDAC is expected to play a leading role in strengthening Chemical safety and security.
12. Chemical safety and security is an issue of concern throughout the lifecycle of chemicals, from research and development, to manufacturing, transportation and storage, distribution, end-use and recycling. This is a shared responsibility amongst many Stakeholders.
13. NAFDAC has always advocated for improved collaboration to build partnership, strengthen existing ones and create synergy in regulation at different levels (National, Regional and International). Some of the strategies used include:
    • Public awareness campaign through the print, social and electronic media.
    • Inter-agency collaboration through use of task forces among regulatory bodies responsible for drugs and controlled substances.
    • Reviews of the drug laws to enable the judiciary apply penalties that are commensurate to the offences.
14. Following the return of NAFDAC to the Ports and Borders, the agency has achieved heightened regulatory alertness, diligence and control of importation of regulated products.

15. There are a number of challenges and limitations confronting the Agency. Some of these include: Inadequate training of the Agency’s officers on chemical safety and security, absence of a specialized chemical laboratory, underfunding that has limited the acquisition of on-the-spot monitoring equipment, system for biometric data capture and operational vehicles for wider coverage and industry monitoring.

Conclusion

I want to emphasize that the law compels all handlers of chemicals to adhere strictly to all the stipulated regulations and guidelines for sound chemical management in order to safeguard our health and protect the environment.

It is my candid opinion that the knowledge acquired at the end of this workshop will support compliance to safe and secured handling of chemicals. It will also set the pace for closer relationship between NAFDAC and the chemical industry.

It is our expectation that the industry on its own should try its best on self-regulations thereby making the job of regulations easier for the Agency. NAFDAC is poised to support the chemical industry to enhance sound chemical management in all the systems.

Thank you all for finding time out of your busy schedules to participate in this workshop. I also express my sincere appreciation to the U.S Department of State’s Chemical Security Program (CSP), their implementing partner Oak Ridge National Laboratory (ORNL) and all others that contributed to the success of this program. I wish you all very successful deliberations