6-Regulation: Nigeria develops National Biosafety Framework

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TITLE:  Developing National Biosafety Framework
SOURCE: This Day, Nigeria, by Chikas Ohadoma
        http://allafrica.com/stories/200212130101.html
DATE:   Dec 12, 2002

------------------ archive: http://www.gene.ch/genet.html ------------------


Developing National Biosafety Framework

At the inauguration of the National Biosafety Committee in Abuja last week, 
Chikas Ohadoma made some important notes which she now reports

The inauguration of the National Biosafety Committee (NBC) and the flagging 
off the development of Nigeria's National Biosafety Frame-work-National 
Coordinating Committee (NCC) last week by the government was to provide a 
means for appropriate decision-making in matters relating to applications 
for deliberate release of living modified organisms (LMOs) and Genetically 
Modified Organisms (GMOs).

Chikas Ohadoma writes that the quest for meanigful environmental management 
and biodiversity conservation, a concern for the loss of biodiversity 
globally led the United Nations to begin a process of addressing globally 
the issues and attempt to arrest in a systematic way the trend.

The launching of the Nigeria Biosafety Committee (NBC) and the National 
CoordinatingCommittee (NCC) for the development of Nigeria's national 
biosafety framework was to address some of the requirements inherent on 
Nigeria's signing the Cartagena protocol on Biosafety (CPB) as well as to 
be able to reach the variety of local and international stakeholders 
interested in biotechnology as a developmental tool for Nigeria.

Inaugurating the committee, Minister of State for Environment Dr. Imeh 
Okopido explained that the National Biosafety Commi-ttee was inaugurated 
for the purpose of giving teeth to government's responsibility to comply 
with the requirements of decision-making inherent in applications for the 
deliberate release of Gen-etically Modified Organisms (GMOs) and Living 
Modified Organisms (LMOs).

The membership of the National Biosafety Commi-ttee (NBC) and the National 
Coordinating Committee (NCC) which has Professor Johnson Ekpere as chairman 
and secretary as the national project coordinator Mr. Mathew Dore, includes 
the federal ministries of Environment; Agriculture and Rural Development, 
Science and Technology, Industry and Health (National food and drug 
administration control- NAFDAC).

Others are the federal ministries of Justice, Commerce, Foreign Affairs, 
Nigeria Customs Services and the Federal Ministry of Education.

Individual members include the National Chamber of Commerce, Industry Mines 
and Agriculture (NACCIMA), Vice chancellor University of Uyo, Professor A. 
H. Ekpo, Dr. (Mrs) Uzochukwu Sylvia of the University of Agriculture 
Abeokuta, Chris Ugwu of the society for the Improvement of Rural People, 
Nsukka, Professor Johnson Ekpere, and Mrs Lamin Lombi.

Addressing the complex nature of the committee, Okopido noted that the 
federal ministry of Environment is the Focal Point for Biosafety in Nigeria 
and reiterated the need for cooperation among all stake-holders, 
particularly, government agencies to avoid the usual pitfalls common in 
administering such complex issues.

"Agencies of government responsible for promotion of biotechnology have the 
mandate to achieve their goals but in doing so, they must recognise the 
role that others charged with safety in food, environment, biodiversity and 
the regulation of the industry must play. Confusion as to the roles to be 
played must not be deliberately set. It would only portray us in bad light 
and send the wrong signal out both locally and internationally."

He stressed that all institutions involved with biotechnology were charged 
with having in-house biosafety bodies, which essentially were to ensure 
compliance with the rules and procedures. "This must not be misconstrued 
with the responsibility for National Biosafety and the administration of 
safety in biotechnology in Nigeria, especially when it comes to the 
transboundary movement of LMOs and GMOs," he said.

Okopido called on all agencies of government, the private sector and civil 
society to commence the use of the existing Guidelines so as to put the 
guideline to the test and create a chance to improve it.

"This document is not cast in concrete. At the end of the framework which 
development you are saddled with, a newer version may come out, as the need 
arises, that takes in tow emerging issues in this fast-growing technology."

Explaining the essence of the event, Okopido said the first step to achieve 
the development of Nigeria's national biosafety framework (NBF) was to 
inaugurate the National Biosafety Committee while the other was to flag off 
the development of Nigeria's National Biosafety Framework. "While the 
former is a national obligation deriving from our signing the Cartagena 
Protocol on Biosafety, the latter is recognised as part of the capacity-
building initiatives by UNEP/GEF to prepare countries for coming into force 
of the Cartagena Protocl on Biosafety."

However, he noted that the development of the Guideline was done on a fast-
track basis to address some of the requirements inherent on signing the 
Cartagena Protocol on Biosafety (CPB). Noting also that concern for the 
possible adverse impacts of releasing Genetically Modified Organisms (GMOs) 
into the environment was expressed right at the very formative stages of 
the Convention on Biological Diversity (CBD) while the CPB was developed to 
address the concern that arise from the release of LMOs into the 
environment.

Okopido recalled that Nigeria had developed Biosafety Guidelines as far 
back as 1994, the document of which he said was not formally adopted by the 
government.

However, he noted that the document was corrected by the Federal Executive 
Council early this year when it adopted for use a new version of the 
Guidelines that responds to Nigeria's obligation under the Cartagena 
Protocol on Biosafety.

The new document he said "addresses gaps which could not have been 
envisaged in the earlier document and states in clear terms the steps to be 
followed for applications for the intentional release of GMOs", Okopido 
said.

He added that the current guidelines represents Nigeria's second attempt at 
controlling the release of LMOs. "As far as regulations go, they are not 
enough to address all the issues necessary to properly control the release 
of LMOs. You would have also observed that there are no penalty clauses. 
Some of you present here participated in that process. That document 
however was not put into much use and was not popularised either. Between 
that time and now, a lot of developments in the field of safe use, handling 
and movement across national boundaries have taken place."

Undoubtedly, the need for the creation of the biosafety frameworks, emerged 
from the need to assist countries prepare for entry into force of the CPB 
with the objectives to assist countries in implementing the CPB through the 
development and implementation of their NBF, promote information sharing 
and collaboration, especially at the regional and sub-regional level and 
promote collaboration with screening notifications and requests for 
completeness.

It would also address risk assessment, including, where appropriate, the 
consideration of risk management, and risk evaluation (including socio-
economic evaluation), decision making within the time frame specified in 
the regulatory mechanism and in accordance with the provisions of 
involvement of stakeholders, and a mechanisms for feedback between the 
different steps.

To successfully carry out the mandate, Okopido said "we intend to raise 
public awareness and create channels for good information flow to the 
public on the issues involved around the release of GMOs and LMOs to 
promote informed debate and to ensure transparency with respect to 
subsisting local and international regulations and standards of play with 
regards to GMOs and LMOs. We would also provide all stakeholders 
opportunity to be involved in the design and implementation of the Nigeria 
Biosafety Framework."

He further explained that the process of developing National Biosafety 
Frameworks consists of four phases involving, setting the required project 
management structures, gathering of baseline information, analysis of that 
information in consultation with stakeholders and preparation of a draft 
National Biosafety Framework.

Okopido said the core elements of the framework embodies, a regulatory 
system, an administrative system, a decision making system that includes 
risk assessment and management and a mechanism for public participation and 
information sharing.

"In addressing our obligations under the CPB we are aware of the great 
potentials that biotechnology offers countries. This work will culminate in 
the legislation, and fine tuning of administrative and policy initiatives 
to regulate modern biotechnology and its application, define the set of 
requirements for imports and exports, production and use", he said.

Furthermore, Okopido noted that Genetic engineering has profound 
implications for food production, choice and security and added that the 
introduction of it must contend with the national aspirations and policy 
goals, Socio-economic consequences including potentially adverse effects on 
food security, Farmers choice, rights and education, Consumer choice and 
health, Environmental consequences and Possible impacts on Biodiversity.

He emphasised that the above are important issues for sustainable 
development and charged the committee that recognising the connection 
between the various endeavours and designing initiatives to properly 
utilize and regulate biotechnology was the twin challenge faced by the 
committee. "These are onerous challenges. The NBF has a life-span of 
eighteen months. Its life-span cannot be extended. The job must be 
completed within the stipulated time frame."

He stressed on the issue of safety in biotechnology saying.

"Internationally and in the United Nations arena, the United Nations 
Environment Programme (UNEP) has been the engine for moving negotiations on 
the issue of safety in biotechnology forward, especially as it pertains to 
its impacts on the environment. UNEP was responsible for the development of 
CBD which came into force after being opened for signature at the United 
Nations Conference on Environment and Development (UNCED) on June 5 1992.

The need for Safety in biotechnology cannot be over emphasised because it 
is one of the issues addressed in CBD. According to Okopido, the concept of 
biosafety as enunciated in CBD refers to the need to protect human health 
and environment from the possible adverse effects of the products of modern 
biotechnology as it has been recognised as having potentials that can 
improve human well being, particularly in agriculture, food and health care.

In keeping with the concept of biosafety, member states, including Nigeria, 
had committed themselves to undertaking national, regional and 
international measures aimed at achieving the three objectives of CBD 
namely, the conservation of biological diversity, the sustainable use of 
its components and, the fair and equitable sharing of the benefits arising 
out of the utilisation of genetic resources.

Giving a brief background on the CBD, Okopido, quoted that the CBD in 
Article 19: Handling of Biotechnology and distribution of its benefits, 
stated "information about the use and safety regulations in handling 
Genetically Modified Organisms, as well as available information on the 
potential adverse impact of specific organisms concerned be made available 
to the contracting Party into which those organisms are to be introduced."

The above he said necessitated a negotiation of a binding agreement, an 
international quest that began in 1995 with a variety of interest groups 
pitched against each other.

The process he added took about five years and saw preparations take place 
on all the continents.

"In January 2000, agreement was reached on the Cartagena Protocol on 
Biosafety (CPB) in Montreal, Canada after more than five years of 
articulation of the elements of the protocol. The Protocol's major plank is 
to contribute to ensuring an adequate level of protection in the field of 
the safe transfer, handling and use of living modified organisms resulting 
from modern biotechnology that may have adverse effects on the conservation 
and sustainable use of biodiversity, taking into account risks to human 
health, and specifically focussing on transboundary movements."

Okopido said that the Nigerian government having recognised the value of 
the CPB, gave approval for Nigeria to sign the protocol. "A major step was 
taken by Nigeria on the 24th of May 2000, when in compliance with 
government directives, Nigeria signed the Cartagena protocol on Biosafety 
(CPB). This epoch-making event which took place in Nairobi, Kenya was part 
of the ceremonies of the Fifth Conference of Parties to the Convention on 
Biological Diversity.

This protocol comes into effect when 50 members ratify it. Currently, there 
are 38 countries which have ratified the protocol."

Outlining the functions of the NBC, the secretary of the committee and the 
national project coordinator, Mr. Mathew Dore said that in recognition of 
the need to provide advice to government on biosafety, the NBC shall among 
other things, be responsible for risk assessment and risk management, 
establish and review, as necessary guidelines or both physical and 
biological containment and or control procedures appropriate to the level 
of assessment risk. NBC shall also consult with the relevant government 
agencies and other organisations as appropriate, advise where appropriate, 
on the training of personnel with regard to safety procedures.

Moreover, NBC is expected to maintain an inventory of laboratories with 
physical and human capacities to conduct research, undertake risk 
assessment and create a database of experiences in the releases of LMOs and 
GMOs in the country. Just as it shall submit an annual report of its 
activities to the national focal Point the federal Ministry of environment 
among other functions.



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