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Country's Decision or any other Communication
Record information and status
Record ID
115336
Status
Published
Date of creation
2020-01-04 20:33 UTC (bchnigeria@gmail.com)
Date of last update
2020-01-21 04:08 UTC (bchnigeria@gmail.com)
Date of publication
2020-01-21 04:08 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, issued to Syngenta South Africa (pty)   limited, as the Developer of Genetically Modified Maize Events 3272 and MZIR093/NBMA /FFP/ D2 /002
Date of the decision
2019-12-20
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
Uses of the LMO(s)
  • LMOs for direct use as food
  • LMOs for direct use as feed
  • LMOs for processing
Has the decision been taken in the absence of a domestic regulatory framework and in accordance with Article 11.6?
No
Importer’s or Applicant’s contact details
SYNGENTA SOUTH AFRICA (PTY) LTD
SYNGENTA SOUTH AFRICA (PTY) LTD
94 Bekker Street, Thornhill Office Park.
Midrand, Cape Town
South Africa
Phone:+27 11 541 4000
Fax:+27 11 541 4022
Email:ppm.eame@syngenta.com
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
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 guide the suitability of the Permit holder:
1. The Permit holder shall, at all times, remain a person with authorised dealings with the GMOs as indicated in this decision and shall comply with the terms and conditions of the Permit.
2. The Permit does not authorise these GMOs for cultivation purposes,
3. This decision relating to the Permit remains in force until it is suspended, cancelled or surrendered or when the authorization period elapses. (No dealings with GMO are authorised during any period of suspension),
4. The persons covered by this decision are the Permit holder and employees, agents or contractors of the Permit holder,
5. The dealings authorised by this Permit are for food, feed and for processing,
6. The Permit Holder shall at all times comply with the content of the decision document.
7. The Permit Holder shall inform the Agency in writing of:
i. any relevant conviction of the Permit Holder occurring after the issuance  of this Permit;
ii. 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;
iii. any event or circumstances occurring after the issuance of this Permit that would affect the capacity of the holder of this Permit to meet the conditions thereto; and
iv. provide any information related to the Permit holder's ongoing suitability to hold a Permit, if requested, within the stipulated period.
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.
8. 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
9. The Permit Holder shall not permit a person covered by this Permit to conduct any dealing unless:
(a) the Permit Holder has obtained from the person an undertaken that the person:
has been informed by the Permit Holder of the Permit conditions including any variation of them; and has understood and agreed to be bound by the Permit conditions, or variation.
10. 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 undertaking referred to in the immediate 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 authorised 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 immediate 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, which provides 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.
If the Permit Holder informs the Agency under the immediate 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
Persons covered by this Permit shall not deal with the GMO except as expressly permitted by this Permit.
Reasons
The conditions have been given to protect the environment from potential impacts of the authorized GMOs
LMO identification
SYN-ØØØ98-3 - Insect resistant herbicide tolerant maize
Syngenta (Novartis (Ciba-Geigy)) Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi) Resistance to herbicides - Glufosinate
SYN-E3272-5 - Enogen™ Maize
Mannose tolerance Selectable marker genes and reporter genes Thermostable alpha-amylase Use in industrial applications - Biofuel production
Show detection method(s)
SYN-ØØØH2-5 - Soy modified for tolerance to Mesotrione and Glufosinate
Resistance to herbicides - Glufosinate
Risk assessment
REPORT OF THE NATIONAL BIOSAFETY COMMITTEE (NBC) ON THE REVIEW MEETING FOR AUTHORIZATION OF GM MAIZE 3272, MZIR098 AND SOYBEAN SYHT0H2 FOR FOOD, FEED AND FOR PROCESSING
SYN-ØØØ98-3 - Insect resistant herbicide tolerant maize
Syngenta (Novartis (Ciba-Geigy))

Resistance to diseases and pests - Insects - Coleoptera (beetles) - Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi)
Resistance to herbicides - Glufosinate
SYN-E3272-5 - Enogen™ Maize
Mannose tolerance
Selectable marker genes and reporter genes
Thermostable alpha-amylase
Use in industrial applications - Biofuel production
SYN-ØØØH2-5 - Soy modified for tolerance to Mesotrione and Glufosinate
Resistance to herbicides - Glufosinate
Decision document