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 or feed, food and processing 8
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 Institute of
Agricultural Research, Samaru, Zaria, Kaduna State, 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 context of this 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 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 conditions address
ongoing suitability of the Permit Holder.
9. The Permit Holder shall at all times comply with the content of
the decision document.
10. 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.
11. 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.
12. 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.
13 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.
14 .The confined field trial site shall be inspected and approved
by the Agency before commencing the trial.
15 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
16. 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
17. 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.
18. 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.
19. 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.
20. 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.
21. 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.
22. Obligations of persons covered by the Permit
23. Persons covered by this Permit shall not deal with the GMOs
except as expressly permitted by this Permit.
24. 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 grown, and on other
activities that can be undertaken.
1. 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.
2. 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
IAR, Zaria, Kaduna State
3. 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.
4. 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 in writing by the Agency.
3.2. 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.
3.3. Physical confinement and site security
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.
3.4. Pollen dispersal
1. Planting Area shall be:
(a) surrounded by a Pollen Trap; or
(b) surrounded by a Monitoring Zone and an Exclusion Zone.
2. 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.
3. 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 cowpea plants;
and
(b) the GMOs shall not be planted in a Planting Area if any
cowpea 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 cowpea 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.
3.5. Dispersal of GMOs
a. The outer edge of a Planting Area, and of a Pollen Trap if used,
shall be at least 50 m away from Waterways.
b. Isolation distance from related non-GMO species should not be
less than 100meters.
c. All cowpea 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 cowpea
plants grown in a Planting Area or Pollen Trap.
(d) The GMOs shall be harvested separately from any other
crop.
(e) 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.
(f) Roots from the GMOs shall be dealt with separately from any
other root.
(g) 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.
(h) Any Equipment used in connection with the GMOs shall be cleaned
as soon as practicable and before use for any other purpose.
(i) 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.
3.6. Dispersal of the GMOs during transport or storage
1. 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:
a. completely wrapped in cellophane; or
b. completely enclosed within metal/plastic container;
c. 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.
(d)Methods and procedures used to transport GMOs shall be recorded,
and shall be provided to the Agency, if requested.
3.7. Persistence of the GMOs or Volunteers post-cleaning.
1. 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.
2. 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.
3. 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 cowpea planted in accordance with the
conditions of this permit; or
ii. listed as post-harvest crops permitted for the GM cowpea field
trial site by the Agency; or
iii. agreed to in writing by the Agency.
3.8. Contingency plan
1. If any unintentional presence of the GMOs is detected outside
the areas requiring inspection, the Contingency Plan shall be
implemented, which include:
a. Notification of the Agency
b. incident and corrective action forms shall be completed for each
case of accidental release.
c. The incorporation of the completed incident and corrective
action forms into the compliance binder maintained at the CFT
site.
d. 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.
e. 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.
f. 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
4.1. 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.
5.1. 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
ii. Method of Cleaning Immediately
(e) Inspection activities i. Information recorded in a Logbook
Within 30 days of inspection
