NATIONAL BIOSAFETY MANAGEMENT AGENCY ACT

(1) There is established the National Biosafety Management Agency (in this Act referred to as the Agency) which:
(a) shall ensure the effective management of all component of the nation's Biosafety;
(b) shall be a body corporate with perpetual succession and a common seal; and
(c) may sue and be sued in its corporate name.
(2) The Agency shall be the national authority on Biosafety in Nigeria.

(1) The objectives of the Agency shall be to:
(a) establish and strengthen the institutional arrangement on Biosafety matters in Nigeria;
(b) safeguard human health, biodiversity and the environment from any potential, adverse effect of genetically modified organism including food safety;
(c) ensure safety in the use of modern biotechnology and provide holistic approach to the regulation of genetically modified organisms;
(d) provide measures for the case by case assessment of genetically modified organisms and management of risk in order to ensure safety in the use of genetically modified organisms to human health and the environment;
(e) provide measures for effective public participation. Public awareness and access to information in the use and application of modern biotechnology and genetically modified organisms; and
(f) ensure that the use of the genetically modified organisms does not have adverse impact on socio-economic and cultural interest either at the community or national level.

The Agency shall:(a) propose, for the approval of the Board, the overall policy guidance on issues of Biosafety in Nigeria;
(b) implement the provisions of the Conventions and the Protocols on matters relating to genetically modified organisms;
(c) render reports to the secretariat of the Convention on the implementation of the Convention and Protocol on matters relating to the use of genetically modified organisms;
(d) develop measures and requirements and criteria for risk assessment peer review and decision making;
(e) develop measures and requirements for risk assessment;
(f) develop risk management plan and strategy for protecting human health, biological diversity and the environment from potential risks associated with genetically modified organisms;
(g) accept and verify applications in respect of genetically modified organisms and keep records of all approvals and unapproved applications as contained in Part VIII, subsection 24 (1);
(h) take samples and carry out laboratory analysis of crops, products or materials for purposes of determining if they contain genetically modified organisms and ensure compliance with this Act;
(i) carry out actions necessary to ensure compliance with the legal obligations set out in this Act, including, but not limited to, the inspection of facilities, conduct research activities with genetically modified organisms covered by this Act, the collection and analysis of samples of materials covered by the Act, the monitoring of human health and the environment to determine the effects of genetically modified organisms regulated by the Act;
(j) liaise with the secretariat of the convention and the Biosafety clearing house with respect to the administrative functions required under the Protocol;
(k) carry out and maintain inventory of laboratories with physical and human capacities to conduct research in modern biotechnology;
(l) monitor the activities of institutional committees and Biosafety officers;
(m) build, equip and maintain offices and premises for the performance of its action under the Act;
(n) pay remuneration, allowances, expenses and any other benefit to members of the Board and employees of the Agency or any other persons, in accordance with the National Salaries, Income and Wages Commission;
(o) carry out capacity building activities;
(p) perform other duties as may be necessary for the full discharge of its functions under this Act; and
(q) partner with other relevant local and international agencies for the speedy realization of the Agency’s mandate.

The Agency shall have such Departments as it may deem appropriate.

There shall be for the Agency a Director General who shall:(a) be appointed by the President, Commander-in-Chief of the Armed Forces on the recommendation of the Minister;
(b) not be qualified for appointment as a Director-General unless he possesses outstanding qualifications and has at least 15 years cognate experience in the Management of Biodiversity, Biosafety or related field;
(c) be a holder of at least a Masters Degree in biological sciences or other related field;
(d) be the Chief Executive of the Agency and be responsible for:
(i) the day to day administration of the Agency;
(ii) the execution of the policies of the Agency; and
(iii) Performing other functions as the Board or Minister may from time to time assign to him.
(e) hold office in the first instance for a term of 4 years and may be reappointed for another term of 4 years and no more.

Notwithstanding the provisions of section 5 of this Act, the Director-General may be removed from office by the President, Commander-in-Chief of the Armed forces:(a) for inability to discharge the functions of his office (whether arising from infirmity of mind or body or any other cause) or for misconduct;
(b) if the President is satisfied that it is not in the interest of the Agency or the public for him to continue in the office;
(c) if the Director-General resigns his appointment by a notice in writing under his hand addressed to the President.

The Agency shall appoint a Secretary and Legal Adviser, who shall be:(a) a legal practitioner of not less than 10 years post-call experience;
(b) subject to the control and supervision of the Board and Director- General; and
(c) keeping the books and records, conducting the correspondence of the Board and performing such other duties as the Board or the Director-General may from time to time direct and without prejudice to the generality of the foregoing, the Secretary shall be responsible for:
(i) making arrangements for meetings of the Board;
(ii) preparing the agenda and minutes of meetings of the Board; and
(iii) such other functions as may be assigned to him by the Board and the Director-General.

The terms and conditions of service and remuneration of employees of the Agency shall be determined in line with the appropriate authorities.

The removal and discipline of staff shall be in accordance with existing Public Service Rules and Regulations.

(1) There is established for the Agency, a Board which shall consist of:
(a) a Chairman who shall be appointed by the President, Commander-in-Chief of the Armed Forces;
(b) the Director-General of the Agency;
(c) a representative not below the rank of a Director, from each Federal Ministry responsible for:
(i) Environment;
(ii) Agriculture;
(iii) Science and Technology;
(iv) Trade and Investment;
(v) Health;
(vi) Nigeria Customs Service;
(vii) National Agency for Food and Drug Administration and Control (NAFDAC); and
(viii) National Biotechnology Development Agency (NABDA).
(d) one representative each of conservation Non-Governmental Organizations (NGOs) and organized private sector;
(e) one representative of the Biotechnology Society of Nigeria.
(2) All appointments in this section shall be made by the President, Commander-in- Chief of the Armed Forces.
(3) Membership of the Board is on part-time, except the office of the Director-General.

A member of the Board appointed, other than the Director-General, shall hold office for a term of 4 years, and subject to the provisions of this Act.

(1) The office of a member of the Board shall become vacant if:
(a) he resigns as a member of the Board by notice in writing under his hand addressed to the President; and
(b) if it appears to the Board that a member of the Board other than an ex-officio member or Director-General should be removed from office on the grounds of misconduct or inability to perform the functions of his office, the Board shall make a recommendation to the President.
(2) Notwithstanding the provisions of subsection (1) of this section, the President may remove any member of the Board if he is satisfied that it is in the public interest to do so.

The Board shall:(a) advise on the overall policy formulation of the Agency in particular with regard to financial, operational and administrative matters;
(b) establish committees as may be expedient and charged with specific functions;
(c) encourage and promote activities related to the functions of the Agency;
(d) carry out such other activities as may be directed by the President.
(2) The Board shall have power to appoint for the Agency either directly or on secondment from any public or civil service of the Federal such number of employees as may, in the opinion of the Board, be required to assist the Agency in the discharge of any of its functions under this Act.

(1) The Agency shall establish and maintain a fund from which it shall defray all expenditures incurred.
(2) There shall be paid and credited to the fund:
(a) annual budget allocation from the Federal Government;
(b) such other sums as may be given to the Agency by the Federal government;
(c) all moneys accruing to the Agency, including grants-in-aid, endowments and donations;
(d) all charges, dues, fees or other amounts collected by the Agency; and
(e) all interests on moneys invested by the Agency.

The Agency shall, when necessary, apply the funds at its disposal for the purpose of the Agency.

The Agency may borrow according to the provisions of the Debt management Act.

(1) The Agency may, subject to the provisions of this Act and conditions of any trust created in respect of any property, invest all or any of its funds in accordance with section 15 (1) of this Act.
(2) The Agency may invest any of its surplus funds in such securities as may be permitted by law.

(1) The Agency may, accept gifts of land, money or other property or things from within and outside Nigeria, on such terms and conditions, if any as may be specified by person or organization offering the gift.
(2) The Agency shall not accept any gift if the terms and conditions attached by person or organization offering the gift are inconsistent with its functions under the Act.

The Agency shall submit to the President, in accordance with the prescription in the annual budget cycle each year, its programme of work and estimates of its income and expenditure for the following year.

(1) The Director-General shall keep proper accounts of the Agency and proper records in relation and to those accounts.
(2) The accounts of the Agency shall be audited after the end of the year to which the audit relates, by auditors appointed by the Agency from among the list and in accordance with the guidelines supplied by the Auditor-General of the Federation.

The Agency shall prepare and submit to the President not later than 6 months after the end of the year a report, in such form as the President directs on the activities of the Agency during the immediate preceding year and shall include in the report a copy of the audited accounts of the Agency or that year and the auditor's report thereon.

As from the commencement of this Act, no person, institution or body shall import, export, transit, carry out the contained use, confined field trial, multi-locational trial without the approval or permit of the Agency.

(1) Any person, institution or body who wishes to import, export, transit or otherwise carry out a contained field trial, multi-locational trial or commercial release of a genetically modified organism shall apply to the Director General of the Agency not less than 270 days to the date of import, export, transit or the commencement of such activity.
(2) Any application under subsection (1) of this section shall include:
(a) the information and data requirement that may be specified by the Agency in the regulations, guidelines, and policy documents;
(b) a risk assessment report indicating the potential risk, if any that the genetically modified organisms may pose to human health including food safety, biological diversity or the environment including the consequence of unintentional releases;
(c) the nature and identity of the genetically modified organisms involved in the activity being proposed to be carried out;
(d) information relating to any release of the genetically modified organisms in Nigeria or elsewhere;
(e) the nature and purpose of the activities including such activities as storage, transportation, production, culture and processing;
(f) destruction, disposal or usage of the genetically modified organisms in any way whatsoever;
(g) a management plan for remediation measures to be undertaken in the event of:
(i) any unintentional introduction into the environment of the genetically modified organisms from contained laboratory;
(ii) the escape or persistence in the environment of a genetically modified organisms from a confined field trial; and
(iii) any unintended consequence to the environment from the placing of genetically modified organisms in the market.
(h) the place where, and the purpose for which the genetically modified organisms or the product thereof is planned to be developed, used, kept, released or marketed including detailed instructions for use and a proposed labelling and packaging scheme in accordance with the First Schedule to this Act; and
(i) a declaration to the effect that the information provided to correct including where appropriate, the undertaking from the origination of such information affirming its accuracy and completeness.
(3) In all cases, the Agency shall set out requirements for each activity with genetically modified organisms to determine the level of potential risk posed by such category of activity in accordance with the second schedule to this Act.

(1) No person, institution or body shall import, export, transit or commercialize any genetically modified organism or a product thereof intended for direct use as food or feed or for processing unless with the approval of the Agency.
(2) Application under this section may only be granted upon completion of safety risk assessment to determine if there is not substantial risk that the genetically modified organism could be eaten by humans or animals.
(3) Any person, institution or body that submits an application under this section for the commercial release of a genetically modified organism must ensure that the application addresses the socio-economic considerations set out in the Third Schedule to this Act.
(4) The Agency shall consider such analysis in the risk or benefit assessment to determine whether it is to be approved or denied.
(5) Review of the food safety assessment and the determination that the food is safe for human consumption shall be certified by the National Agency for Food, Drug Administration and Control.

(1) The Agency shall upon the receipt of the application and the accompanying information under Section 23 of this Act, display copies of such application and relevant information at such places and for such period as the Agency may, from time to time determine to enable the general public and relevant government ministries and agencies study and make comments on the application and relevant information within 21 days.
(2) The Agency may, prior to the display, make announcement in at least 2 national and one local newspapers, the national Biosafety clearing house or such other news media as the Agency may from time to time determine, giving summary of the application and brief information on the place, duration and time for the display.

(1) The Agency may, in addition to the comment received pursuant to section 23 of this Act, hold public hearings or consultations to obtain further comments and inputs that will assist in the review or processing of the application.
(2) Notwithstanding any other provisions in this Act the Agency shall not disclose any confidential business information submitted by any person, institution or body to the Agency under this Act.
(3) To determine if any information identified by an applicant qualifies as confidential business information that cannot be disclosed to the public the Agency shall ascertain that:
(a) the information has not previously been released to the public anywhere in the world;
(b) the applicant has shown that it has taken steps to prevent the release of such information;
(c) release of the information would be detrimental to the applicant; and
(d) the information is not required to be released under section 23 of this Act.

(1) The following information shall not be considered confidential business information and can be disclosed to the public:
(a) the name and address of the applicant;
(b) a general description of the genetically modified organism;
(c) a summary of the risks assessment for the genetically modified organisms;
(d) any scientific data that specifically addresses potential environmental or food risk from genetically modified organisms and any method; and
(e) plans for emergency response.

With respect to any decision taken under section 23 of this Act, the Agency:(a) shall take into consideration, the relevant comments, inputs or concerns of the public received under the provisions of this Act;
(b) shall notify the applicant in writing and the Biosafety clearing house of the decision and information, facts and analysis supporting the decision;
(c) shall notify the public of any genetically modified organism for which approval or permit has been granted for import , contained use, confined field trials, multi-locational trials or commercial release and provide the information, facts and analysis supporting the decision;
(d) may specify the steps to be taken in the implementation of the risk management plan where there are potential risk to human health, animal, plant and the environment.
(e) may in respect of any approval for import, transit, contained use, confined field trial, multi-locational trials or commercial release of any genetically modified organisms, direct the applicant to carry out monitoring and evaluation of risk for a specified period equivalent to the life cycle of the relevant species or for such period as the Director General may, from time to time, determine;
(f) impose any additional measure for risk management as provided in this Act;
(g) do such other things as take such other steps as he may consider necessary and expedient for carrying into effect this decision.

The Agency may:(a) revoke or suspend the approval or permit or otherwise review any decision taken under section 23 of this Act if it is of the opinion that there is new information to the effect that the genetically modified organisms or its products thereof is capable of having adverse effect on human health, animal, plant or the environment; and
(b) review the refusal of an application if there is new and relevant information.

(1) Any applicant who is aggrieved by any decision of the Agency under sections 24 and 25 of this Act may appeal to the Board to reconsider that decision, stating his grounds of appeal, including any additional information.
(2) Any applicant who is not satisfied with the decision of the Minister may apply to the Federal High Court for a review of the decision.

(1) Every applicant seeking approval for any genetically modified organism under this Act shall, prior to the submission of the application, carry out a mandatory risk assessment of the potential risk the genetically modified organisms poses to human health, animal, plant or the environment in Nigeria.
(2) The risk assessment mentioned in subsection (1) of this section shall be carried out in Nigeria and in accordance with policies and guidelines set forth by the Agency and under the Third Schedule to this Act.
(3) Without prejudice to subsections (1) and (2) of this section, the Agency may constitute a National Biosafety Committee (NBC) to carry out risk assessment of any genetically modified organism under this Act.
(4) Where the National Biosafety Committee (NBC) carries out the risk assessment, the Agency may direct that such applicant bears the cost of carrying out the risk assessment notwithstanding that the applicant has previously carried out his own risk assessment.

No person, shall be involved in a risk assessment review by the Agency in respect of a subject matter in which:(a) he has direct or indirect interest of any kind; or
(b) there is likely to be conflict of interest as a result of his participation in the risk assessment process.

Every person, institution or body that carries out any activity relating to genetically modified organisms shall develop and maintain a risk management plan and strategy in accordance with the provisions of the Forth Schedule to this Act.

The Agency may impose additional measures for management of risks associated with any genetically modified organisms and without prejudice to the generality of the foregoing, may:(a) direct that any genetically modified organisms undergo a period of observation commensurate with the life cycle or generation time, at the cost of the applicant before or after such genetically modified organism is certified for usage;
(b) prohibit the import transit, contained use, release or placing on the market of any genetically modified organism if it contains characteristics or specific traits which pose significant risk to human health, animal, plant and the environment;
(c) require any person, institution or body responsible for any activity relating to genetically modified organisms to take such measures as may be necessary, from time to time, to prevent or limit any human health animal, plant or the environment;
(d) direct any applicant under section 24 of this Act to submit periodic report of the monitoring and evaluation of risk carried out after the approval or permit granted under this Act; and
(e) undertake any measure, as may be reasonably necessary to avert risk or danger to human health, animal, plant and the environment where the person responsible for such action fails to act and the person so responsible shall bear the cost of any measure taken;

(1) Any person, institution or body who:
(a) imports, export transit or otherwise carries out the activity of contained use or commercial release of any genetically modified organisms without a prior approval or permit of the Agency; or
(b) contravenes the conditions of the grant of an approval or permit under this Act, commits an offence and shall be liable on conviction:
(i) in the case of an individual, to a fine of not less than N2,500,000.00 or imprisonment for a term of not less than 5 years or both such fine and imprisonment; or
(ii) in the case of a body corporate to a fine of not less than N5,000,000 and, in addition, the directors or officers of the body corporate shall each be liable to a fine of not less than N2,500,000.00 or imprisonment for a term of not less than 5 years or both such fine and imprisonment.
(2) For the purpose of section 24 (1) of this Act, any applicant who:
(a) becomes aware, after the grant of approval or permit to him, of any new information which indicates that the genetically modified organism poses possible risk to human health, animal, plant or the environment and fails to give such information to the Agency; and
(b) gives any false information purporting to be new information that suggest that the genetically modified organisms in respect of which approval or permit was refused has not adverse effect on human health, animal, plant or the environment, commits an offence under this Act and shall on conviction be liable to:
(i) in the case of an individual, to a fine of not less than N2,500,000.00 or imprisonment for a term of not less than 5 years or both such fine and imprisonment; or
(ii) in the case of a body corporate to a fine of not less than N5,000,000.00 and in addition, the directors or officers of the body corporate shall each be liable to a fine of not less than N2,500.000.00 or imprisonment for a term of not less than 5 years or both fine and imprisonment.

Any person, institution or body who submits or supplies false information in respect of any activity relating to genetically modified organism under this Act commits an offence and shall be liable on conviction:(a) in the case of an individual, to a fine of not less than N2,500,000.00 or imprisonment for a term of not less than 3 years or both such fine and imprisonment; or
(b) in the case of a body corporate, to a fine of not less than N5,000,000.00.

Any person who obstructs an authorized officer in the course of his duties under this Act, commits an offence and is liable on conviction to a fine of not less than N2,500,000.00 or imprisonment for a term of not less than 3 years or both such fine and imprisonment.

(1) Any person who contravenes any provision of this Act for which no specific penalty is specified, commits and offence and is liable on conviction to a fine of not less than N2,500,000.00 or imprisonment for a term not exceeding 3 years or both such fine and imprisonment.
(2) Notwithstanding the punishments provided under section 36, 37 and 38 of this section, the Agency shall, in addition, revoke the permit granted to the individual or institution or body.

The Agency shall have powers to:(a) in company of a Law Enforcement Officer, enter the premises, facility, laboratory, field, farm or other place, institutions or bodies covered by this Act to take action necessary to determine compliance with the Act;
(b) conduct, monitor and assess the impact of genetically modified organisms covered by the Act on human health, animal, plant or the environment;
(c) take other actions that include, but not limited to review and copy documents collecting samples, data interview individuals and seizing genetically modified organisms; and
(d) in addition to paragraphs (a), (b) and (c) of this section, seal or close down any facility, Confined Field Trials (CFT) sites, farms and laboratories.

(1) The Federal High Court shall have jurisdiction to try offences under this Act.
(2) The Court may, in addition to the penalties provided under this Act, order the forfeiture of any specimen, genetically modified organisms, or any genetic material, asset, other materials or anything in connection with commission of an offence under this Act.
(3) Without prejudice to subsection (2) of this section, the Court may order that:
(a) premises, laboratory, facility, field, farm or any place be sealed up for such period as be specified in such order; or
(b) remediation measures be undertaken by the offender.

(1) The Board may, on the recommendation of the management of the Agency, make regulations generally for carrying into effect the provisions of this Act:
(a) handling, transporting, packaging; fault-based liability and redress for damages from the activities of modern biotechnology and genetically modified organisms. Liability and Redress for a damage that occurs as a result of an activity under this ACT is subject to applicable laws; and
(b) without prejudice to the generality of the provisions of subsection (1) of this section, the Agency may provide safety standards, guidelines and rules on:
(i) public participation processes and procedures;
(ii) risk assessment and risk management;
(iii) laboratories and relevant equipments relating to genetically modified organisms;
(iv) identification or labelling of genetically modified organisms; and
(v) fees and charges payable by applicants for any activities of the Agency under this Act.

The Agency shall:
(i) purchase, hold, take on lease or dispose of any interest in land, building or property;
(ii) build, equip and maintain offices and premises for the performance of its action under the Act;

43. In this Act:
“Agency” means National Biosafety Management Agency establishment under section 1 (1) of this Act;
“Appropriate authority” includes the National Salaries Incomes and Wages Commission”;
“Biosafety Clearing House” means a pool of information mechanism established under Article 20 of the Protocol for exchange of scientific, technical, environment and legal information on and experience with genetically modified organisms, as part of the clearing house mechanism under Article 18 of the Convention;
“Biosafety” means the application of measures, policies, knowledge, techniques, equipment and procedures for minimizing potential risks that modern biotechnology may pose to the environment and human health;
“Board” means the National Biosafety Management Agency Governing Board established under Section 11 (1) of this Act;
“Committee” means the National Biosafety Committee referred to under Section 32 (3) of this Act;
“Contained use” means any operation using modern biotechnology undertaken within a facility, installation or other physical structure, such as a building, laboratory or greenhouse;
“confidential business information” consist of trade secrets and other proprietary information of commercial value;
“confined field trial” means a small scale experimental release into the environment of a genetically modified organism under physical and biological confinement conditions that limit the genetically modified organism's persistence in the environment after the experiment is completed;
“commercial release” means the release of genetically modified organism into the market as a product that can be purchased and use by any individual, such as a genetically engineered seed or animal;
“Conservation” means the protection of maintenance of nature while allowing for its ecologically sustainable use;
“convention” means the Convention on Biological Diversity;
“Court” means the Federal High Court;
“food and feed product” means a genetically modified organism or its product that is used for food, feed or processing and is primarily intended for consumption by humans or animals or for the consumption of both humans and animals;
“genetic material” means any part of a plant or animal or microbial containing functional units of the heredity;
“genetically modified organisms” means any organism living or non living that possesses a novel combination of genetic material obtained through the use of modern biotechnology;
“modern biotechnology” means the application:
(a) in-vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (rDNA) and direct injection of nucleic acid into cells or organelles; or
(b) fusion of cells beyond the taxonomic family that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection;
“member” means a member of the committee and includes the Chairman;
‘Minister” means Minister in charge of Environment;
“Director-General” means Chief Executive Officer of the Agency;
“Protocol” means the Cartagena Protocol on Biosafety to the Convention on Biological Diversity;
“products thereof” means processed materials that are of genetically modified origin containing detectable novel combination of replicable genetic material obtained through the use of modern biotechnology;
“Institutional Biosafety Officer” means officer who is knowledgeable in Biosafety and has a degree in any of the biological science that is, Medical Science, Zoology, Genetic, Microbiology, Biochemistry, Veterinary Medicine, Animal Science, Soil Science, Agronomy or Plant Science (Botanist) and Ecology and appointed by the Institute dealing with Modern biotechnology for the purpose of ensuring compliance with the provisions of this Act.

This Act may be cited as the National Biosafety Management Agency Act, 2015.