Nigeria | BCH-DEC-NG-261278 | Country's Decision or any other Communication | Biosafety Clearing-House

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BCH-DEC-NG-261278-1   |   PDF   |   Print   |  

Country's Decision or any other Communication (DEC)

last updated: 05 Aug 2022
Amendment
No
General Information
Decision Document for a Permit for Importation and use of Genetically Modified (GM) Wheat for Food, Feed and for Processing issued to Trigall Genetics S. A. /NBMA/FFP/IM/021
EN
13 Jul 2022
No
Subject of the decision, notification, communication or declaration
  • Decision on LMOs for intentional introduction into the environment (according to Article 10 or domestic regulatory framework)
LMOs for intentional introduction into the environment
No
Yes
No
No
Result of the decision
Approval of the import and/or use of the LMO(s) with conditions
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 the suitability of the Permit holder: 1. The Permit holder shall, at all times, remain an organisation with an authorised dealings with the GMO or an affiliate of such an organisation and shall comply with its terms and conditions of the Permit.2. This Permit does not authorise dealings with GMOs that are otherwise prohibited for cultivation purposes. 3. This Permit remains in force until it is suspended, cancelled or surrendered or authorization period elapses. (No dealings with GMOs are authorised during any period of suspension). The holder of this permit ('the permit holder') is Trigall Genetics S. A. 4. The persons covered by this permit are the permit holder and employees, agents or contractors of the permit holder and other persons who are, or have been, engaged or otherwise authorised by the permit holder to undertake any activity in connection with the dealings authorised by this permit. 5. The dealings authorised by this Permit are for importation, transport, storage , commercialization, food, feed and processing, 6. The Permit Holder shall notify the Agency as soon as practicable if any of the contact details of the project supervisor changes.7. The Permit Holder shall ensure that the GMO or product thereof are properly labelled in line with the provisions of the National Biosafety Management Agency Act 2015 (as amended) and the National Biosafety Regulations 2017. Note: please address correspondence to nbma@nbma.gov.ng Prior to issuing a Permit the Agency considers suitability of the applicant to hold a Permit. The following additional conditions also address the suitability of the Permit Holder: 8. The Permit Holder shall at all times comply with the content of the decision document. 9. The Permit Holder shall: (a) inform the Agency in writing; of i. The date for off-loading GM wheat consignment and transportation to the storage facility at least 2 weeks before commencement; ii. any relevant conviction of the Permit Holder occurring after the issue of this Permit; iii. any revocation or suspension of a 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; iv. any event or circumstances occurring after the issue of this Permit that would affect the capacity of the holder of this Permit to meet the conditions thereto; and (b) provide any information related to the Permit holder’s ongoing suitability to hold a Permit, if requested, within the stipulated period. 10. The Permit Holder shall be able to access all distribution points, commercial points, all Milling Plant Areas, storage and other approved facilities to the extent necessary to comply with this Permit, for the duration of the life of the Permit. The following conditions seek to ensure that persons conducting the dealings are aware of the Permit conditions and appropriate processes are in place to inform people of their obligations.11. Prior to conducting any dealings with the GMO, the Permit Holder shall provide to the Agency: (a) names of all organisations and persons or functions or positions of the persons who will be covered by the Permit, with a description of their responsibilities if possible; and Note: Examples of functions or positions are distributors, Plant manager, Store manager etc. (b) detail of how the persons covered by the Permit will be informed of Permit conditions; and (c) detail of how the Permit Holder will access all commercial points, distribution points Milling Plant Areas, storage and other approved facilities to the extent necessary to comply with this Permit, for the duration of the life of the Permit Note: this may include a description of any contracts, agreements, or other enforceable arrangements.(d) a Contingency Plan to respond to inadvertent presence of the GMOs outside an area that shall be inspected or manifestation of risks. 12. Any changes to the information provided under the immediately preceding condition shall be communicated in writing to the Agency within 7 days of the changes occurring. 13. The storage facility shall be inspected and approved by the Agency before distribution. 14. 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 15. The Permit Holder shall not permit a person covered by this Permit to conduct any dealing unless: (a) the person has been informed of any applicable permit conditions, including any variation of them;(b) the Permit Holder has obtained from the person an undertaken that the person: i. has been informed by the Permit Holder of the Permit conditions including any variation of them; and ii. has understood and agreed to be bound by the Permit conditions, or variation. 16. The Permit Holder shall: (a) inform the persons covered by this Permit that any Personal Information relevant to the administration and/or enforcement of the Permit may be released to the Agency; and (b) provide the Agency, if requested, with copies of the undertaken referred to in the immediately preceding condition. 2.2 Provision of new information to the Agency: 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 condition requires that any new information that may affect the risk assessment is communicated to the Agency.The Permit holder shall inform the Agency 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 authorized by the Permit. Note: The Act requires, for the purposes of the above condition, that: i. the Permit Holder will be taken to have become aware of additional information of a kind mentioned in paragraph 2.2 ii. the Permit Holder will be taken to have become aware of contraventions, or unintended effects, of any kind, Note: Contraventions of the Permit may occur through the action or inaction of a person. If the Permit holder is required to inform the Agency under the immediately preceding condition, the Agency shall be informed without delay.Note: An example of informing without delay is contact made at the time of the incident via the NBMA phone number (+2348180805451), which provides emergency number 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. 2.3 If the Permit Holder informs the Agency under the immediately preceding condition and the Agency requests further information, the further information shall be provided in a manner, and within the period, stipulated by the Agency. 2.4 Obligations of persons covered by the Permit 1. Persons covered by this Permit shall not deal with the GMOs except as expressly stated in 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 Agency, or a person authorised by the Agency, to enter premises where the dealing is being undertaken, for the purposes of auditing, monitoring, inspecting the dealing or enforcement by the Agency.Section 3 Limits and control measures 3.1. Limits on the release The following permit conditions maintain the risk assessment context within which the application was assessed, by imposing limits on where and when the GMOs may be imported which is at Lagos sea Port, and on other activities that can be undertaken. i. The only GM wheat that may be stored at storage facility, sold, processed are: a. the GM wheat covered by this Permit as described in Attachment A of the Permit; b. the volume of Grains approved for importation in writing by the Agency. ii . Importation, Storage, sale and processing of the GMO may only occur within the following limits: 3.2. Volume and durationMaximum volume of the import Duration 150,000 MTS As approved by NBMA 3.3. Locations of store As communicated to the Agency by permit holder prior to importation 3.4. Additional Conditions:. i. The GM wheat shall not be planted and shall not be allowed to grow anywhere pursuant to this permit; ii. Storage facility should be well-fortified to prevent volunteering due to dispersal of grains by rodents and theft, Note: The Contingency Plan shall be implemented if the GMOs are detected outside under ultivation.3.5. Dispersal of the GMOs during transport or storage Transport and storage of GMOs outside the Storage Area shall: a. only occur to the extent necessary to conduct the dealings permitted by this Permit or other valid authorisation; and b. be in accordance with the Agency’s Guidelines for the transport, storage and disposal of GMOs or c. if grains are transported in a bag shall be: i. completely wrapped in cellophane; or ii. completely enclosed within metal/plastic container; iii. labelled for the transport, storage and disposal of GMOs as current at the time of transportation. Note: Signed statements by persons transporting or disposing of the GMOs should be made.d. Transport of GMOs for the purpose of export is permitted on notification to the Agency as the permit holder would have authorisation to export the GMOs to the destination country. e. Methods and procedures used to transport GMOs shall be recorded, and shall be provided to the Agency, if requested. 3.6. Persistence of the GMOs or Volunteers post-cleaning at large scale processing plants i. After Cleaning, related areas shall be inspected by persons trained by the Permit holder to recognise volunteers and actions taken as follows:Area Period of inspection Inspection frequency Inspect for Action (a) Storage Area (b) Processing areas that have been cleaned and where the GMOs may be able to establish*. From the day of Cleaning. Same as above At least once every 30 days. Same as above Volunteers. Same as above Destroy immediately. Same as above ii. Details of any inspection activity shall be recorded in a Logbook and shall include: (a) date of the inspections; (b) name of the person(s) conducting the inspections; (c) details of the experience, training or qualification that enables the person(s) to recognise Volunteers, if not already recorded in the logbook; (d) details of areas inspected,(e) details of any Volunteers observed including number, developmental stage and approximate position of the Volunteers within each area inspected and (f) date(s) and method(s) of destruction of any Volunteer plants. 3.7. Contingency plan 1. If any unintentional presence of the GMO is detected outside the areas requiring inspection, the Contingency Plan shall be implemented, which include: a. Notification of the Agency a. incident and corrective action forms shall be completed for each case of accidental release. b. The incorporation of the completed incident and corrective action forms into the compliance binder maintained at the storage and/or milling sites. c. in the event that transgenic material falls out of its sealed packaging and carrying bag during the transport process the transgenic material will be immediately recovered and returned to its storage which will be marked for subsequent destruction through incineration. d. if GM grains are accidentally removed from the storage facility, the NBMA should be notified immediately of the event and efforts should be undertaken to recover the material by the Permit Holder under the guidance of the Agency. e. In the unlikely event of civil unrest or natural disaster that affects the integrity of storage facility beyond recovery, NBMA should be notified by the Permit holder and requisite action would be taken. Section 4 Reporting and Documentation The following Permit conditions are imposed to demonstrate compliance with other conditions, facilitate monitoring/Inspection of compliance by staff of the Agency. Notifications shall be sent to the Agency as follows: Notice Contents Timeframe (a) Intention to import i. Details of the consignment, volume, entry port, name of vessel and final destination including, the state, local government area and city/town, a street address and any other directions ii. Date on which the GMOs will off-loaded iii. Period when the GMOs are expected to be transported to storage facility iv. Period distribution / sale is expected to commence v. How processed product is intended to be used is packaged At least 7 days prior to importation
EN
This is to ensure biodiversity conservation
EN
LMO identification & risk assessment
  • BCH-LMO-SCBD-259261-1 Living Modified Organism IND-ØØ412-7 - Drought-tolerant wheat (HB4 wheat)
    INDEAR S.A. | Resistance to herbicides (Glufosinate), Tolerance to abiotic stress (Drought, Salinity)
  • BCH-RA-NG-261277-1 Risk Assessment generated by a regulatory process RECOMMENDATION OF THE NATIONAL BIOSAFETY COMMITTEE (NBC) ON AN APPLICATION BY TRIGALL GENETICS S.A FOR THE FOOD, FEED AND PROCESSING AUTHORISATION FOR IND-ØØ412-7 WHEAT
    IND-ØØ412-7 - Drought-tolerant wheat (HB4 wheat) | Wheat, Resistance to herbicides, Tolerance to abiotic stress
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