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Country's Decision or any other Communication
Record information and status
Record ID
114250
Status
Published
Date of creation
2019-02-04 11:09 UTC (bchnigeria@gmail.com)
Date of publication
2019-02-04 11:09 UTC (bchnigeria@gmail.com)

General information
Country submitting the decision or communication
  • Nigeria
Competent National Authority(ies) responsible for the decision or communication
NATIONAL BIOSAFETY MANAGEMENT AGENCY.
National Parks Building, Umaru Musa Yar'adua Expressway, Airport Road
ABUJA, FCT-ABUJA
Nigeria
Phone:2348033147778
Fax:234-9-5234119
Email:biosafetyng@gmail.com
Title / Reference number of the decision or communication
Decision Document for a permit for the Commercial release of Pod Borer - Resistant Cowpea (PBR - Cowpea)-event AAT709A,  genetically modified for lepidopteran insect pest (Maruca vitrata) resistance, issued to Institute for Agricultural Research (IAR), Zaria/NBMA/CM/02
Date of the decision
2019-01-22
Is the decision taken prior to entry into force of the Protocol?
No
Is this an amendment to a previous decision / communication?
No
Decision or communication details
Subject(s) of the decision
  • Decision on LMOs for intentional introduction into the environment (according Article 10 or domestic regulatory framework)
Was the decision triggered by a request for a transboundary movement of LMOs into the country?
No
Does the decision apply to transboundary movements of LMO(s) into the country?
No
Importer’s or Applicant’s contact details
Prof Mohammad Ishiyaku
Institute of Agricultural Research (IAR)
Ahmadu Bello University, Samaru
Zaria, Kaduna
Nigeria
Phone:+234 69551355, +2348051316887
Fax:+234 69550563
Email:mffaguji@hotmail.com
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
2.1 Obligations of the Permit Holder
Prior to issuing a Permit, the NBMA considers suitability of the applicant to hold a Permit. The following conditions address ongoing suitability of the Permit holder.
1. The holder of this permit ('the permit holder') is Institute for Agricultural Research, Zaria
2. The Permit Holder shall:
(a) inform the NBMA immediately in writing, of:
i. any relevant conviction of the Permit Holder occurring after the commencement of this Permit; and
ii. any revocation or suspension of a Permit or permit held by the Permit Holder under a law of the Nigerian Government, a State or a foreign country, being a law relating to the health and safety of people or the environment; and
iii. any event or circumstances occurring after the commencement of this Permit that would affect the capacity of the holder of this Permit to meet the conditions in it; and
(b) provide any information related to the Permit Holder's ongoing suitability to hold a Permit, if requested, within the stipulated period;
3. The Permit Holder shall inform any person covered by this Permit, to whom a particular condition of the Permit applies, of the following:
(a) the particular condition (including any variations of it); and
(b) the cancellation or suspension of the Permit; and
(c) the surrender of the Permit.
2.2 Provision of new information to the NBMA.
Permit conditions are based on the risk assessment and risk management plan developed in relation to the application using information available at the time of assessment. The following conditions require that any new information that may affect the risk assessment is communicated to the NBMA.

1.The Permit Holder shall inform the NBMA if the Permit Holder becomes aware of:
(a) additional information as to any risks to the health and safety of people, or to the environment, associated with the dealings authorised by the Permit; or
(b) any contraventions of the Permit by a person covered by the Permit; or
(c) any unintended effects of the dealings authorised by the Permit.

Note: The Act requires, for the purposes of the above condition, that:
(a) By the provision of section 35(2)(a) of the Act, the Permit Holder will be taken to have become aware of the additional information, if he or she was reckless as to whether such information existed; and
(b) The Permit Holder will be taken to have become aware of contraventions, or unintended effects, of a kind mentioned in condition 2, if he or she was reckless as to whether such contraventions had occurred, or such unintended effects existed.

Note: Contraventions of the Permit may occur through the action or inaction of a person.
2. If the Permit Holder is required to inform the NBMA under the immediately preceding condition, the NBMA shall be informed without delay.

Note: An example of informing without delay is contact made within 24 hours of the incident via the NBMA phone numbers +2348180805451 and +2347086117730 which are emergency numbers for incidents that occur out of business hours. Notification without delay will allow the NBMA to conduct a risk assessment on the incident and attend to the location, if required.

3.If at any time the NBMA requests the Permit Holder to collect and provide information about any matter to do with the progress of the dealings authorised by this Permit, including but not limited to:
(a) additional information as to any risks to the health and safety of people, or to the provided environment, associated with the dealings authorised by the Permit, whether or not the Permit Holder has information to the NBMA under condition 15(a);
(b) any contraventions of the Permit by a person covered by the Permit, whether or not the Permit Holder has provided information to the NBMA under condition 15(b);
(c) any unintended effects of the dealings authorised by the Permit, whether or not the Permit Holder has provided information to the NBMA under condition 15(c);
(d) research, including by way of survey, to verify predictions of the risk assessment, or for any purpose related to risks to the health and safety of people, or to the environment;
(e) scientific literature and reports in respect of the GMOs authorised by this Permit, for a period of time that the Agency may deem fit in the circumstance;

(f) details of any refusals of applications for Permit or permits (however described) to deal with the GMOs made pursuant to the regulatory laws of a foreign country; and the request is reasonable, having regard to consistency with the Act and relevance to its purpose, then the Permit holder shall collect the information and provide it to the NBMA at a time and in the manner requested by the NBMA.
Note: The NBMA may invite the Permit holder to make a submission on the reasonability of a request, collect and provide information relevant to the progress of the dealings with the GMOs.
2.3 Obligations of persons covered by the Permit.
1.Persons covered by this Permit shall not deal with the GMOs except as expressly permitted by this Permit.
2.If a person is authorised by this Permit to deal with the GMOs and a particular condition of this Permit applies to the dealing by that person, the person shall allow the NBMA, or a person authorised by the NBMA, to enter the premises where the dealing is being undertaken, for the purposes of auditing, inspecting, monitoring the dealing or enforcement of compliance.
3.All persons covered by the Permit shall ensure that all GMO materials are properly labelled in line with the provisions of the National Biosafety Management Agency Act 2015 and the National Biosafety Regulations 2017.
4. The permit holder or grower of this GMO  under this permit shall ensure adequate measures of coexistence between related species of the  GMO in the form of isolation distance or  planting time isolation on the farm.
5. Any  intended grower of this GM cowpea of up to  50hectres shall ensure that  five percent of the plot is under afforestation. 
Section 3 Reporting and Documentation Requirements
3.1 Annual Report
1.The Permit holder shall provide periodic report of activities at various stages of the dealing period and a detailed Annual Report to the NBMA at the end of the dealing. An Annual Report shall include the following:
(a) the locations where dealings on the GMOs are taking place within Nigeria,
(b) information about any adverse impacts, unintended effects, or new information relating to risks, to human health and safety or the environment caused by the GMOs or material from the GMOs;
(c) information about the initial  volumes of the GMOs grown for commercial purpose, including seed increase operations, in each State for the first  growing season in the period;
(d) information about the volumes of the GMOs grown for non-commercial (e.g. research) purposes in each State for each growing season in the period.
Note: nil plantings should also be reported.
3.2 Testing methodology
1.Prior to conducting any dealings with the GMOs, the Permit Holder shall provide to the NBMA a written methodology to reliably detect the GMOs, and the presence of the genetic modifications described in this Permit in a recipient organism. The detection method shall be capable of reliably distinguishing between the specific genetic modifications in the GMOs described in this Permit and other genetic modifications in the PBR Cowpea.
2.The permit holder  shall also provide simple detection kits of the gene of insert to the NBMA prior to dealing.
Reasons
To ensure compliance to the provisions of Nigeria Biosafety Law of 2015
Does the decision involve field trials?
No
Does the decision involve commercial release?
Yes
LMO identification
AAT-7Ø9AA-4 - Pod Borer-resistant cowpea
AATF and Institute of Agricultural Research Resistance to antibiotics - Kanamycin Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths)
Show detection method(s)
Risk assessment
RECOMMENDATION OF NATIONAL BIOSAFETY COMMITTEE (NBC) ON AN APPLICATION BY INSTITUTE OF AGRICULTURAL RESEARCH (IAR), AHMADU BELLO UNIVERSITY ZARIA FOR GENERAL RELEASE/COMMERCIALISATION OF COWPEA GENETICALLY MODIFIED FOR INSECT RESISTANCE (AAT 709A) APPLICATION REF: NBMA / CM/002
Cowpea
AATF and Institute of Agricultural Research
Decision document
Decision document