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Country's Decision or any other Communication (DEC)
last updated: 18 Jun 2022
Decision Document for a Permit for Confined Field Trial of Genetically Modified Potato for late blight resistance issued to the National Root Crops Research Institute (NRCRI), Umudike/NBMA/CFT/006EN
03 Jun 2022
- Decision on LMOs for intentional introduction into the environment (according to Article 10 or domestic regulatory framework)
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 ongoing suitability of the Permit holder. 1. The Permit holder shall, at all times, remain an accredited or an affiliate of an accredited 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 marketing 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). 4. The holder of this permit ('the permit holder') is National Root Crops Research Institute, Umudike, Nigeria 5. 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. 6. The dealings authorised by this Permit are to conduct experiments with the GMOs, breed, propagate, grow, import, transport, and dispose of the GMOs and the possession, supply or use of the GMOs in the course of any of these dealings. 7. The Permit Holder shall notify the Agency as soon as practicable if any of the contact details of the project supervisor (Principal Investigator) changes. 8. The Permit Holder shall ensure that all GMO materials are properly labelled in line with the provisions of the National Biosafety Management Agency Act 2015. Note: please address correspondence to email@example.com Prior to issuing a Permit the Agency considers suitability of the applicant to hold a Permit. The following conditions address ongoing 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 planting at least 2 weeks before commencement; ii. any relevant conviction of the Permit Holder occurring after the issue of this Permit; and 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; and 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. 9. The Permit Holder shall be able to access all Exclusion Zones (if any) and to access and control all Planting Areas, Pollen Traps (if any), Monitoring Zones (if any) and 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. 10. Prior to conducting any dealings with the GMOs, 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; and Note: Examples of functions or positions are ‘trial manager’, ‘site labourer’ 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 Exclusion Zones (if any), and access and control Planting Areas, Pollen Traps (if any), Monitoring Zones (if any) and approved facilities for the duration of the Permit; and Note: this may include a description of any contracts, agreements, or other enforceable arrangements. (d) written methodology to reliably detect the GMOs or the presence of the genetic modifications in a recipient organism, and to distinguish between categories of GMOs approved for release; and (e) a Contingency Plan to respond to inadvertent presence of the GMOs outside an area that shall be inspected. 11. 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. 12. The confined field trial site shall be inspected and approved by the Agency before commencing the trial. 13. 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 14. 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) Trained on the dealing and (c) 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. iii. Would not embark on strike 15. 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. 16. 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 authorised by the Permit. Note: It 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 16(a) if he or she was reckless as to whether such information existed; and ii. the Permit Holder will be taken to have become aware of contraventions, or unintended effects, of a kind mentioned in paragraph 16(b) or 16(c) 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. For example, if it is a condition of the Permit that volunteers are destroyed prior to reaching maturity and a volunteer reaches maturity, then the person responsible for controlling volunteers will have contravened that Permit condition. 17. 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. 18. 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. 2.3 Obligations of persons covered by the Permit 19. Persons covered by this Permit shall not deal with the GMOs except as expressly permitted by this Permit. 20. 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 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 grown, and on other activities that can be undertaken. 21. The only plants that may be grown at a Planting Area are: (a) the GMOs covered by this Permit as described in Attachment A of the Permit; (b) plants approved in writing by the Agency. 22. Planting and growing of the GMOs may only occur within the following limits: Area and duration Maximum size of any Planting Area Duration As indicated in the application As indicated in the approval State and location in which Planting Areas may be located Jos, Plateau state. 23. Plant Material shall not be used, sold/Commercialized or otherwise disposed of for any purpose which would involve or result in its use as food for humans or feed for animals. 24. If experimentation or analysis with the GMOs is not conducted in accordance with requirements, experimentation or analysis with the GMOs may only be undertaken within: (a) a Planting Area prior to post-harvest Cleaning; or (b) a facility approved by the Agency. Confinement measures The following permit conditions maintain the risk assessment context within which the application was assessed by restricting spread and persistence of the GMOs. Incinerators should be located in Confined Field Trial sites for the purpose of burning of all waste GMOs materials and volunteers. Physical confinement and site security 25. The trial site shall be adequately secured with: (a) perimeter fence of wire mesh/gauze; (b) 24-hour security personnel; (c) clearly written sign posts at the four corners of the perimeter fence indicating CFT site of the GMOs and contact phone No. Pollen dispersal 26. A Planting Area shall be: (a) surrounded by a Pollen Trap; or (b) surrounded by a Monitoring Zone and an Exclusion Zone. 27. If a Pollen Trap is used in accordance with the previous condition, Pollen Trap Plants shall: (a) have a reasonably dense and vigorous growth; and (b) be Flowering at the same time as the GMOs; and (c) form a continuous barrier at least 20 m wide around the Planting Area while the GMOs are flowering, although one path of up to 2.5 m in width is allowed in order to access the Planting Area. 28. If a Monitoring Zone and an Exclusion Zone are used in accordance with condition 27: (a) while the GMOs are being grown in the Planting Area, the Monitoring Zone shall be maintained in a manner appropriate to allow the identification and Destruction of potato plants; and (b) the GMOs shall not be planted in a Planting Area if any potato plant, other than a crop planted pursuant to this permit is present in the Exclusion Zone; and (c) the Monitoring Zone and Exclusion Zones shall be inspected by people trained to recognise Volunteers, and actions taken as follows: Area Period of inspection Inspection frequency Inspect for Action Monitoring Zone From 14 days prior to the expected commencement of Flowering of any GMOs* until all GMOs have been harvested or Destroyed At least once every 30 days Volunteers Destroy before Flowering Exclusion Zone From 7 days prior to the expected commencement of Flowering of any GMOs* until all GMOs have finished Flowering At least once every 30 days Intentionally planted soybean Destroy before Flowering; alternatively, Destroy the GMOs before Flowering * Permit holder is required to provide information to the Agency on the expected flowering period, however the inspection period should be based on the observed development of the GMOs, so that inspections commence prior to any GMOs flowering. Note: Details of any inspection activity shall be recorded in a Logbook as detailed. Dispersal of GMOs 29. The outer edge of a Planting Area, and of a Pollen Trap if used, shall be at least 50 m away from Waterways. 30. Isolation distance from related non-GMO species should not be less than 100meters. 31. All potato plants grown at a Planting Area or Pollen Trap are considered the GMOs for the purposes of this permit. Note: All conditions applying to the GMOs also apply to potato plants grown in a Planting Area or Pollen Trap. 32. The GMOs shall be harvested separately from any other crop. 33. If GMOs are destroyed, they are taken to have been harvested for the purposes of this permit and all conditions applying to post-harvest apply equally to post-destruction. 34. Roots from the GMOs shall be dealt with separately from any other root. 35. Areas of land used in connection with the GMOs shall be Cleaned as follows: Areas to be Cleaned When (a) Planting Area (b) Pollen Trap Within 30 days of harvest of the GMOs or within 9 months of planting the GMOs, whichever occurs first (c) any area where GMOs may have dispersed during planting, growing or harvesting, including irrigation channels and drains (d) any area used to Clean any Equipment used in connection with the GMOs (e) any area used to Destroy GMOs (f) any area used to peel, store or experiment with GMOs As soon as practicable and before use for any other purpose Note: Areas of land that have been cleaned, or from which the GMOs have been harvested, are also subject to Inspections. Cleaning activities shall be recorded and notified to the Agency. 36. Any Equipment used in connection with the GMOs shall be cleaned as soon as practicable and before use for any other purpose. 37. Any extreme weather event that is expected to affect or has already affected a Planting Area or Pollen Trap, while the GMOs are growing or while the areas are subject to inspection requirements, shall be notified in writing to the Agency as soon as practically and reasonably possible. Note: The Contingency Plan shall be implemented if the GMOs are detected outside areas under inspection. Dispersal of the GMOs during transport or storage 38. Transport and storage of GMOs outside the Planting 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 National Biosafety Regulations/Guidelines on Identification, Transport, Storage and Disposal of GMOs or (c) if harvested Plant Material is 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. 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. 39. Methods and procedures used to transport GMOs shall be recorded, and shall be provided to the Agency, if requested. Persistence of the GMOs or Volunteers post-cleaning 40. After Cleaning, areas of land 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) Planting Area (b) Pollen Trap (c) Other areas of land that have been cleaned and where the GMOs may be able to establish*. From the day of Cleaning until: i. the area is replanted with the GMO; or ii. the Agency has issued a Sign-off for the area. At least once every 30 days Volunteers Destroy before Flowering This excludes, for instance, areas with hard floors used to peel, store or experiment on GMOs. 41. 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 including current land use and recent management practices applied; (e) details of any post-harvest rainfall events including measurements at or near the area, or any irrigation events; (f) details of any Volunteers observed including number, developmental stage and approximate position of the Volunteers within each area inspected and (g) date(s) and method(s) of Destruction of any Volunteer plants. Examples of acceptable ways to record the positional information for Volunteers and Related species in the Logbook include: - descriptive text - marking on a diagram - indicating grid references on corresponding map/sketch. Note: Details of Inspection activities shall be provided to the Agency. 42. While post-Cleaning inspection requirements apply to an area: (a) the area shall be maintained in a manner appropriate to allow identification of Volunteers; and (b) no plants may intentionally be grown in the area unless the plants are: i. the GMOs and non-GM potato planted in accordance with the conditions of this permit; or ii. listed as post-harvest crops permitted for the GM potato field trial site by the Agency; or iii. agreed to in writing by the Agency. Contingency plan 43. If any unintentional presence of the GMOs is detected outside the areas requiring inspection, the Contingency Plan shall be implemented, which include: i. Notification of the Agency ii. incident and corrective action forms shall be completed for each case of accidental release. iii. The incorporation of the completed incident and corrective action forms into the compliance binder maintained at the CFT site. iv. 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. v. if GM plants are accidentally removed from the trial site after planting, 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. vi. In the unlikely event of civil unrest or natural disaster that affects the integrity of the CFT beyond recovery, the NBMA should be notified by the Permit holder and the entire experiment will be destroyed. Section 4 Sign off 44. The Permit Holder may make written application to the Agency that planting restrictions and inspection conditions no longer apply to an area if: (a) all post-Cleaning inspection activities have been conducted for at least 12 months on the area and all associated areas of land; and (b) no Volunteers have occurred on these areas in the most recent six-month inspection period. Note: Associated areas refer to a Planting Area and the aggregate of all other areas of land requiring post-Cleaning inspections in respect of that Planting Area. Associated areas will be signed-off as a group rather than individually. Permit conditions require Cultivation for each Planting Area and Pollen Trap prior to a Sign-off application. The Agency will take into account the management and inspection history for all associated areas, including tillage, irrigation, rainfall and occurrence of Volunteers, in deciding whether or not further inspections are required to manage persistence of the GMOs. Section 5 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, and emphasise appropriate selection of the Planting Area. 45. Notifications shall be sent to the Agency as follows: Notice Contents Timeframe (a) Intention to Plant i. Details of the Planting Area including size, the state, local government area and city/town, GPS coordinates, a street address and any other directions ii. Identity of the GMOs to be planted at the Planting Area iii. Date on which the GMOs will be planted iv. Period when the GMOs are expected to Flower v. Period when harvesting is expected to commence vi. How the Planting Area is intended to be used during the first year following harvest vii. A history indicating whether the Planting Area and Pollen Trap have previously been subject to flooding (if known); and viii. Whether the Planting Area will be surrounded by a Pollen Trap or by a Monitoring Zone and isolation distance At least 7 days prior to each planting (to be updated immediately if the notified intended planting dates change) (b) Planting i. Actual date(s) of planting the GMOs ii. Any changes to the details provided under part (a) Within 7 days of any planting (c) Harvest i. Actual date(s) of harvesting the GMOs Within 7 days of commencement of any harvesting (d) Cleaning i. Actual date(s) on which any areas needing Cleaning were Cleaned ii. Method of Cleaning Within 7 days of completion of any Cleaning (e) Inspection activities i. Information recorded in a Logbook Within 30 days of inspection
For the protection of the environment while the trial is on-going
BCH-LMO-SCBD-259172-1 Living Modified Organism Phytophthora-resistant potatoIndonesian Center for Agricultural Biotechnology and Genetic Resource Research and Development(ICABIOGRAD) | Resistance to antibiotics (Kanamycin, Neomycin), Resistance to diseases and pests, Selectable marker genes and reporter genes
BCH-RA-NG-260749-1 Risk Assessment generated by a regulatory process REPORT OF THE NATIONAL BIOSAFETY COMMITTEE (NBC) ON AN APPLICATION BY NATIONAL ROOT CROPS RESEARCH INSTITUTE, UMUDIKE, TO CONDUCT A CONFINED FIELD TRIAL ON LATE BLIGHT RESISTANT TRANSGENIC POTATOPhytophthora-resistant potato | Potato, SOLTU, Resistance to diseases and pests, Resistance to antibiotics, Selectable marker genes and reporter genes