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Version- September 23, 2006

Guidelines on Biosafety for Nigeria

Federal Ministry of Agriculture and Natural Resources March 1994

Guidelines on Biosafety for Nigeria

Contents:

NATIONAL BIOSAFETY COMMITTEE (NBC)

INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)

ANNEXES

GUIDELINES ON BIOSAFETY FOR NIGERIA*, **

Introduction

 

Biotechnology, whether traditional or modern, has been exploited in different ways to serve various human needs. The importance of biotechnology is that it helps in generating products relevant to agriculture, human and animal health, industry, and the environment. Traditional biotechnology, already known for centuries, involves the technologies that have been and still are in use in the brewing and fermentation industries and in the production of animal vaccines. Modern biotechnology, however, includes, among other technologies, cell and tissue culture, monoclonal antibodies, and recombinant DNA (rDNA) or "genetic engineering" techniques. The increased precision and shorter time required in producing results with modern biotechnology make these new techniques particularly attractive.

Genetic engineering has introduced a new dimension to biotechnology. With this technology scientists can recombine DNA from different organisms, giving rise to genetically modified organisms (GMOs). rDNA organisms are derived by introducing a small section of DNA from a "donor" organism to a "recipient& organism. The genome of the recipient organism is, therefore, modified. The results of this modification need to be assessed for risks to humanity or the environment before the organism is freely released or deployed. The issues of public and environmental safety concerning every biotechnology product or application must be carefully considered.

The potential influence of modern biotechnology in our lives is far-reaching and the possible number of products high Developing countries, like their developed counterparts, can derive tremendous benefits from these techniques of biotechnology. Each country should devise appropriate regulatory guidelines to ensure that the products are safe.

* In developing these guidelines for biosafety for Nigeria, use has been made of documents listed in Annex 1.

** In view of the rapid changes occurring in biotechnology, it is necessary that this document should be reviewed from time to time.

An international biosafety information network and advisory service already exists to provide help The information currently available includes a general framework and guidelines that can ensure the safe application of the GMOs in research, development, trade, and utilization

Background

 

The need to establish National Biosafety Guidelines is in consonance with the National Policy on Environment and is a first major step in fulfilling the obligations in the handling of biotechnology and the distribution of its benefits that are stipulated in the International Convention on Biological Diversity Biosafety systems are intended to protect the entire environment of which biodiversity is a component. It also helps to fulfill our obligation under the Environmental Impact Assessment (EIA) Decree No. 86 of 1992, which calls for a precautionary approach to development to ensure that Nigeria is well prepared to manage biohazards. Consequently, it is advisable to:

(a) Develop guidelines, standards, codes of practice and monitoring capabilities for both research and development (R&D) and prerelease assessment of the risk associated with release into the environment of GMOs.

(b) Develop a sound scientific database, upon which risk assessment and evaluation of products can be made.

(c) Provide guidelines to ensure safety of developers and end-users of biotechnology products.

(d) Promote the development and enforcement of regulations in harmony with national priorities and international approaches.

(e) Foster a favorable climate for developing and accelerating innovation and for adopting sustainable biotechnology products and processes.

Objectives

 

The National Biosafety Guidelines will promote opportunities for the application of innovative biotechnology products. The guidelines will be broad-based and adaptable to new knowledge and advances in biotechnology, focusing on: the characteristics and risks of biotechnology products used in agricultural, medical/pharmaceutical, and industrial production. the review process for efficiency and effectiveness of the products as well as safety in terms of public health and the environment; and integration of the release process of biotechnology products into the overall regulatory system that governs the release of new products. Utilization of GMOs in research and development, as well as industrial production processes, should ensure public and environmental safety, with particular attention paid to accident prevention, containment, and waste disposal. The need to prevent accidents is even more imperative as released organisms could easily reproduce in the environment and spread into neighboring countries. In view of these, there is need for a program for the safe development of biotechnology. Equally necessary are measures for risk evaluation and reduction in all operations, as well as the prescription of appropriate conditions for the use of biotechnology and its products since the nature and scale of risks are currently not fully known. Biotechnology processes and GMOs can be classified according to the potential hazards they represent. Processes involving the use of GMOs, the suitability of installations and equipment where such processes are carried out, and the control of the different operations should be subject to nationally approved, specific guidelines.

These guidelines shall cover the following:

(a) Genetically engineered microorganisms

(b) Genetic transformation of plants and animals

(c) rDNA technology in vaccine and pharmaceutical products development.

(d) Large-scale production and deliberate or accidental release of microorganisms, plants, animals, and products derived from rDNA technology.

(e) Appropriate measures to avoid adverse effects on human health and the environment, which might arise from the deliberate or accidental release of GMOs.

(f) Provision of a foundation for a scientifically based process of risk assessment for the development and authorization of release of specific GMOs. This assessment will be part of continuing R&D, evaluation, and commercialization of organisms with novel characteristics.

(g) Importation and use of GMOs and other biotechnology products.

(h) Creation of awareness within the public of the benefits of biotechnology.

Risk Assessment

 

Safety considerations in the applications of biotechnology are imperative since possible risks in R&D involving recombinant DNA modified microorganisms, plants, and animals have been recognized.

(a)     Risk/safety assessment of a GMO should be based on the nature of the GMO and the environment into which it will be introduced and not on the method by which it was modified. In essence, key aspects of risk assessment should include the factors affecting the survival, reproduction, and dissemination of the GMOs in the environment, the stability of the organism in terms of genetic traits, its capability to transfer genetic material, and routes of potential dissemination. Other important considerations include methods for the detection, identification, and monitoring of the organism and for detecting transfer of the donated DNA to other organisms; and the relevant attributes of the site where the GMOs will be used.

(b) In risk and safety assessments of GMOs, experience elsewhere can help in determining the degree of confinement or containment.

(c) Possible types of risks to be assessed on GMOs, for example, in agricultural biotechnology, are

(i) potential for the plants to become weeds;

(ii) likely toxicity of plants and plant materials;

(iii) potential pathogenicity of microorganisms;

(iv) potential for animals to become pests;

(v) potential for other hazards to human beings, plants and animals;

(vi) potential for environmental hazards.

(d) Field testing: There is a long history of utility and safety in the use of plants and microorganisms. Society has benefited from the use of genetically modified microorganisms and plants, and field testing is essential to increase our knowledge of the relative safety or risk of large-scale use of GMOs and to determine their potential utility.

For field-testing of genetically modified microorganisms, risks can be minimized or eliminated by adopting good development practice to confine the introduced microorganisms to the target environment.

In all cases involving microorganisms, plants, and animals, the following should be taken into consideration:

(i) vector-host specificity and stability;

(ii) potential for vector &leakage" into unintended hosts in the environment;

(iii) nature and ease of possible recombination and spread of suchvectors.

(e) Familiarity: "Familiar" does not necessarily mean "safe". Rather, to be familiar with the elements of an introduction means to have enough information to be Able to judge its safety or risk. Frameworks for the evaluation of likely risks involved in the release of animals, plants or microorganisms have been suggested according to the following criteria.

(i) Is sufficient knowledge available concerning the properties of the organism and the environment into which it may be introduced

(ii) Can we confine or control the organisms effectively?

(iii) What are the probable effects on the environment, should the introduced organism or genetic trait persist longer than intended or spread to non- target environments and organisms?

Other information required for risk assessment includes:

(iv) identity of the GMO and specific genetic modification included in the GMO; e.g., DNA sequence, copy number, plasmid border integrity, and pedigree information for traditionally bred offspring of previously assessed GMOs;

(v) phenotypic expression of the GMO relative to the corresponding counterpart of the same species, including information on mating and reproductive behaviors of the GMO;

(vi) potential interactions of the GMO with various forms of life, including identification of anticipated or observed specific relative differences of the GMO compared with its counterpart and interactions with other forms of life;

(vii) other potential environmental impact; e.g., potential excessive population increase in the environment, competitive advantage of the GMO in relation to the unmodified form, identification and description of the target organisms, anticipated mechanism and result of interaction between the GMO and target organism, likelihood of post-release shift in biological interaction or host range, other potentially significant interaction with the environment (e.g., effect on non-target organisms), and impact on population levels and on other organisms (e.g., prey, hosts, symbionts, predators, parasites and pathogens).

When the familiarity standard for a plant or microorganism is such that there is reasonable assurance that the organism and the other conditions of an introduction are essentially similar to known introductions, and when those have proven to present negligible risk, the introduction is assumed to be suitable for field testing, according to established practice. The familiarity criterion is central to the suggested evaluation framework. It permits decision makers to draw on past experience in introducing plants and microorganisms into the environment, and it provides for flexibility. As field tests are performed, information will continue to accumulate about the organisms, their phenotypic expression, and their interactions with the environment. Eventually, the entire class of introductions may become familiar enough to require minimal oversight.

When knowledge of the type of modification, the species being modified, or the target environment is insufficient to meet the familiarity criterion, the proposed introduction must be evaluated according to whether the organism can be confined or controlled, as well as the potential effects of a failure to confine or control it-- which define the relative safety or risk of the introduction.

(f) Level of risk: In evaluating the potential risks associated with GMOs and new technologies, the appropriate questions are:

(i) What are the relative risks of the new technologies compared with the risks of the existing technologies?

(ii) What are the potential risks of overregulation or failing to fully develop new technologies?

(iii) How are risk determinations incorporated in cost and benefit evaluations?

The aim is not necessarily to achieve zero risk. Concerns over potential risks of introducing GMOs should not lead to too stringent and expensive regulations which can impede development of new technologies that can lead to exciting new and beneficial organisms and products.

 

Risk Management

 

For each planned GMO release, the authority should ensure that there is compliance with the safety conditions which were developed from the results of the risk assessment. That should include appropriate control procedures, and procedures for terminating the experiment and disposing of wastes.

Once action is complete on risk assessment, adequate regulatory action should be taken to ensure appropriate risk management, including the following:

(a) Contained use and practice: Good laboratory practice, good occupational safety and hygiene (see annex 2), as well as well qualified and competent personnel, are prerequisites for biotechnology.

(b) GMO use and release:

There must be

(i) judicious choice of DNA vector and host to ensure that vector infectivity is host-specific and controls host vector survival in the external environment.

(ii) appropriate containment for the microorganisms, plants, and animal systems being manipulated which reflects the expected risk level of the GMO.

(c) Additional action is called for as follows.

(i) Appropriate authorities at the national or institutional level should oversee the introduction of GMOs. One or more authorities may be appropriate to cover specific areas; e.g., foods, pesticides, pharmaceuticals, agriculture, among others.

(ii) Risk assessment and management should be carried out by competent bodies. It may be necessary to seek expertise from outside the particular country. However, ultimate decisions must rest with the country.

(iii) Case-by-case evaluation should be the rule based on the premise that the risk of a particular application cannot be determined theoretically, but only empirically.

(iv) For field testing, genetically modified plants, which exhibit traits that are unfamiliar in the unmodified plant will require careful evaluation in small-scale field tests, where plants which exhibit undesirable phenotypes can be destroyed.

v) Step-by-step analysis should progress from controlled trials to less controlled and/or larger geographical trials based on acceptable results from prior tests.

NATIONAL BIOSAFETY COMMITTEE (NBC)

 

For purposes of safe management of biotechnology activities, including research, development, introductions and use of GMOs, Nigeria, like other countries, needs to establish a national biosafety committee (NBC).

Subcommittees could be established by the NBC for sectoral interests such as agriculture, health, industry, and environment.

Membership

 

Membership of NBC should comprise the following:

(a) Scientists

Biologist (1) *

Environmentalist (1)

Physical scientist (1)

Social scientist (1)

(b) Relevant ministries/agencies

Federal Ministry of Agriculture (1)

Federal Ministry of Science and Technology (1)

Federal Ministry of Industry (1)

National Agency for Food and Drug Administration and Control (NAFDAC) - (1)

Federal Environmental Protection Agency (FEPA) - (1)

(c) Community

Public sector (1)

Organized private sector (1)

(d) The Federal Ministry of Agriculture will provide the secretariat. The chairman should be appointed from among the members.

Tenure

 

Members of NBC should serve for three years in the first instance and are eligible for re-appointment for a second term only.

Responsibilities of NBC

 

(a) Formulate policy and procedures at the national level;

(b) Provide technical advice.

Terms of Reference for NBC

In recognition of the need to provide advice to government agencies on the assessment of the risks and benefits associated with the production and/or application of GMOs and other biological materials produced in laboratories, the NBC shall

 

 

(a) Establish and review, as necessary, guidelines for both physical and biological containment and/or control procedures. appropriate to the level of assessed risk involved in relevant research, development, and application activities.

(b) Consult with relevant government agencies and other organizations as appropriate;

(c) Submit an annual report to the Minister of Agriculture and also report within 15 days on any accidents or any breaches of the guidelines cited in (a) above and on other relevant matters referred to it;

(d) Establish contact and maintain liaison with appropriate monitoring bodies in other countries and with international organizations;

(e) Advise, if appropriate, on the training of personnel with regard to safety procedures;

(f) Collect and disseminate information relevant to the above, having due regard to the special circumstances relating to proprietary information;

(g) Maintain an inventory of laboratories with physical and human capacities to conduct research in rDNA; also create a database of experiences in the releases of GMOs in the country;

(h) Establish and oversee the work of scientific subcommittees, whose guidelines follow and whose role and function include not only participation in the foregoing items (b), (c), (d), (f), and (g), but also all research performed under contained laboratory conditions.

The national biosafety technical subcommittee shall:

(a) Be formed, one each for the various disciplines (e.g., agriculture, health, industry, environment) to support the work of the NBC. They shall enter into discussion directly with those scientists and institutions working on biotechnology and with fund-granting bodies in order to determine the conditions under which research should be conducted;

(b) Review proposals for such research and recommend the conditions under which experiments should be conducted, or whether work not be undertaken;

(c) Provide technical advice to the NBC and contribute to its functions in relation to laboratory-contained research.

Relationship of NBC with Regulatory Bodies

The NBC will have to deal with bodies having responsibilities for:

(a) Assessment and regulation of in-country research:

In this connection, the NBC shall set out required guidelines for laboratory and field research while establishing necessary structures and responsibilities to ensure their implementation by the relevant organizations in the country.

In Nigeria, the National Committee on Crop Varieties and Livestock Breeds (Registration, etc.), Decree No. 33 of 1987, which is charged with the responsibility for crop varieties and livestock breed validation and release, may be used with appropriate modification to regulate the use of the products of modern biotechnology.

(b) Assessment of safety of imported and exported biotechnology products:

Relevant regulatory authorities shall have the responsibilities for importation and exportation of biotechnology products. The NBC is expected to play an active advisory role with these agencies, by assisting in assessing the adequacy of the tests carried out in the product's country of origin or of the adequacy of tests carried out on products of biotechnology to be exported.

(c) Assessment of environmental effects of biotechnology products:

NBC should cooperate with and aid FEPA to develop up-todate tests for monitoring the effects of biotechnology products in the environment.

INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)

 

All institutions in Nigeria, both private and public (e.g., research institutes, universities and polytechnics, international research institutes, industrial research and development units which plan to undertake biotechnology research and/or development), must each establish an institutional biosafety committee (IBC), which will be responsible to, and cooperate with, the NBC.

Actions and Responsibilities of Institutions

Responsibilities of the institution will include:

(a) Establishment of guidelines for biotechnology research, which should be subject to review in line with developments in that field;

(b) Establishment of an institutional biosafety committee (IBC). Where a critical mass of scientists to constitute the IBC is not available, the institution may jointly form one committee with other institutions, or rely on the IBC of another institution;

(c) Assistance to principal investigators (PIs) responsible for research to

make sure that the research is conducted in accordance with established guidelines;

(d) Appointment of a biosafety officer who will monitor and advise on biosafety issues on a day-to-day basis;

(e) Establishment of provisions to make available to the public information on experiments conducted at the institution, subject to established guidelines, unless it contains confidential business information or unless its disclosure is prohibited by law, and to make available a general description o f information withheld;

(f) Assurance that the IBC reports promptly to the NBC any significant problems witll implelllelltation of established guidelines;

(g) Assurance that the IBC reports to the NBC within 15 days any research related accidents that have resulted or could result in human illness, in unanticipated plant or animal disease, or in the escape of organisms under study from the intended confinement.

Composition of the IBC

 

The IBC should include:

(a) Five members, including the biosafety officer, so selected that, as a group, they have experience and expertise for evaluation of the biosafety and environmental effects of biotechnology research, including the use of rDNA techniques;

(b) Two members not affiliated with the institution but knowledgeable in biotechnology, and representing the interests of the community; such as

(i) members of government public health or environmental agencies,

(ii) persons active in human, plant or animal health concerns,

(iii) persons active in environmental concerns.

The membership of IBC under categories (i), (ii), and (iii) does not imply affiliation with the institution.

Responsibilities of the IBC

The terms of reference of IBC are to:

(a) Consult with and seek approvals from the NBC;

(b) Implement the recommendations of the NBC;

(c) Establish and implement policies that provide for the safe conduct of biotechnology research and ensure compliance with applicable guidelines;

(d) Review and endorse applications from PIs;

(e) Create and maintain a central reference file and library of catalogs, books, articles, newsletters, and other communications as a source of advice and reference, including such items as the availability of safety equipment, the availability and level of biological containment for various host vector systems, suitable training of personnel, and data on the potential biohazards associated with certain technologies;

(f)Develop a safety and operations manual and assist PIs in the required staff training;

(g) Certify the safety of facilities, procedures, and practices and that the level of training and expertise of the personnel involved have been reviewed and approved;

(h) Review all biotechnology research conducted and sponsored by the institution for compliance with established guidelines. In effect, IBC should establish a program of inspections to ensure that the physical containment facilities and field trials continue to meet requirements and that other procedures and practices specified in the guidelines are followed;

(i) Maintain a list of PIs, project supervisors, and other supervisors approved by the IBC as competent to perform supervisory duties for particular proj