Decision Document for a Permit for Confined Field Trial of Genetically Modified Cassava (AMY3 RNAi Transgenic lines) modified for post-harvest starch reduction issued to the International Institute of Tropical Agriculture (IITA).
This decision document is issued by the National Biosafety Management Agency (NBMA) as permit in accordance with the National Biosafety Agency Act 2015.
The advice of National Biosafety Committee, National Biosafety Technical Sub-committee and public views, guided the decision of the National Biosafety Management Agency. The Agency was convinced that there are no known adverse impacts to the conservation and sustainable use to of biodiversity taking into account risk to human health. This Permit is without prejudice to other extant national laws and regulations.
This Permit authorises the Permit holder and persons covered by the permit to conduct specified dealings with the genetically modified organism referred to in this decision document.
Note about where dealings with GMOs are being undertaken pursuant to this Permit
Information about where the GMOs have been planted pursuant to this Permit is that they were previously tested only in screen house at ETH Plant Biotechnology Laboratory in Zurich, Switzerland.
- In this Permit:
- unless defined otherwise, words and phrases used have the same meaning as they do in
The National Biosafety Management Agency Act 2015;
- words importing a gender include any other gender;
- words in the singular include the plural and words in the plural include the singular;
- words importing persons include a partnership and a body whether corporate or otherwise;
- references to any statute or other legislation (whether primary or subordinate) are a reference to the constitution of the Federal Republic of Nigeria or other legislation of the Federal Republic of Nigeria as amended or replaced from time to time and equivalent provisions, if any, in corresponding States Law, to the extent of any inconsistency with the above mentioned legislations;
- where any word or phrase is given a defined meaning, any other part of speech or other grammatical form in respect of that word has a corresponding meaning;
- specific conditions of this permit shall prevail over standard conditions to the extent of any inconsistency.
- In this Permit:
‘Act’ means the National Biosafety Management Agency Act 2015or the corresponding national legislation under which this Permit is issued.
‘Clean’ (or ‘Cleaned’) means, as the case requires:
- in relation to an area specified in this Permit as requiring Cleaning, the Destruction of the GMOs in that area, to the reasonable satisfaction of the National Biosafety Management Agency; or
- in relation to Equipment, the removal and Destruction of the GMOs from the Equipment, to the reasonable satisfaction of the National Biosafety Management Agency.
‘Contingency Plan’ means a written plan, detailing measures to be taken in the event of the unintended presence of the GMOs outside an area that shall be inspected. A Contingency Plan shall include procedures to:
- ensure the National Biosafety Management Agency is notified immediately if the Permit holder becomes aware of the event; and
- recover and/or Destroy the GMOs; and
- inspect for and Destroy any Volunteers that may exist as a result of the event.
‘Cassava’ means plants of the species Manihot esculenta crantz
- till the soil in a manner which will promote the germination of cassava stems; and
- provide adequate soil moisture to promote the germination of cassava stems.
‘Destroy’ (or ‘Destroyed’ or ‘Destruction’) means, as the case requires, killed by one or more of the following methods:
- stalk pulling; or
- root cutting and mulching/slashing; or
- ploughing; or
- burning/incineration; or
- treatment with herbicide; or
- hand weeding; or
- autoclaving; or
- burial under at least one (1) metre of soil; or
- grinding seeds; or
- a method approved in writing by the National Biosafety Management Agency.
Note: ‘As the case requires’ has the effect that, depending on the circumstances, one or more of these techniques may not be appropriate. For example, in the case of killing the remains of harvest of the GMOs, treatment of post-harvest remains by incineration may not be a sufficient mechanism.
‘Equipment’ includes, but is not limited to, harvesters, seeders, storage equipment, transport equipment (e.g. bags, containers, trucks, etc.), clothing and tools.
‘Exclusion Zone’ means an area extending at least 1.5 kilometres outwards from the outer edge of a Planting Area, which shall be kept free of deliberately planted (GM and non-GM) Cassava while the GMOs are growing in the Planting Area.
‘Flowering’ is taken to begin when any plant of the class of plants referred to in a particular condition first flowers, and is taken to end when all plants in the class of plants no longer have flowers.
‘GM’ means genetically modified.
‘GMOs’ means the genetically modified organisms that are the subject of the dealings authorised by this Permit. GMOs include live plants, root stock that is able to grow into live plants, and viable seed.
‘Logbook’ means a written or electronic record containing information required to be maintained by this Permit holder rand which is able to be presented to the NBMA on request.
‘Monitoring Zone’ means an area of land extending at least 100 metres in all directions from the outer edge of a Planting Area.
‘Natural Waterways’ means waterways other than irrigation channels, holding dams or storage ponds used to collect water runoff from irrigated areas.
‘NBMA’ means the National Biosafety Management Agency.
‘Personal Information’ means information or an opinion (including information forming part of a database), whether true or not, and whether recorded in a material form or not, about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
‘Planting Area’ means an area of land where the GMOs are intentionally planted and grown pursuant to this Permit, but does not include the Pollen Trap.
‘Plant Material’ means any part of the Cassava plants grown in a Planting Area or in the Pollen Trap with respect to a Planting Area, whether viable or not. This includes, but is not limited to, seed, stubble and pollen, whether from the plant itself or derived from or produced by the plant.
‘Pollen Trap’ means an area of land extending at least 25 metres outwards from the outer edge of a Planting Area, where only Pollen Trap Plants are grown.
‘Agency’ means the National Biosafety Management Agency.
‘Sign-off’ means a notice in writing from the National Biosafety Management Agency, in respect of an area, that post-harvest obligations no longer apply in respect of that area.
‘Volunteers’ means GM or non-GM cassava plants, which have not been intentionally grown.
‘Waterways’ means all permanent natural waterways and man-made waterways that flow into natural waterways.
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.
- 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.
- This Permit does not authorise dealings with GMOs that are otherwise prohibited for marketing purposes.
- 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 International Institute of Tropical Agriculture, Ibadan Nigeria
- 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.
- 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.
- The Permit Holder shall notify the Agency as soon as practicable if any of the contact details of the project supervisor changes.
- 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.
- The Permit Holder shall at all times comply with the content of the decision document.
- The Permit Holder shall:
- inform the Agency in writing of:
- The date for planting at least 2 weeks before commencement;
- any relevant conviction of the Permit Holder occurring after the issue of this Permit; and
- 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
- 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
- provide any information related to the Permit holder’s ongoing suitability to hold a Permit, if requested, within the stipulated period.
- 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.
- Prior to conducting any dealings with the GMOs, the Permit Holder shall provide to the Agency:
- 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’, ‘farm labourer’ etc.
- detail of how the persons covered by the Permit will be informed of Permit conditions; and
- 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.
- 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
- a Contingency Plan to respond to inadvertent presence of the GMOs outside an area that shall be inspected.
- 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.
- The confined field trial site shall be inspected and approved by the Agency before commencing the trial.
- The Permit Holder shall inform any person covered by this permit, to whom a particular condition of the permit applies, of the following:
- the particular condition (including any variations of it); and
- the cancellation or suspension of the permit; and
- the surrender of the permit
- The Permit Holder shall not permit a person covered by this Permit to conduct any dealing unless:
- the person has been informed of any applicable permit conditions, including any variation of them;
- Trained on the dealing and
- 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.
- The Permit Holder shall:
- 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
- provide the Agency, if requested, with copies of the undertaken referred to in the immediately preceding condition.
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:
- 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
- any contraventions of the Permit by a person covered by the Permit; or
- any unintended effects of the dealings authorised by the Permit.
Note: The Act requires, for the purposes of the above condition, that:
- 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
- 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 and the permit holder would be liable.
- 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, 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 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.
- Persons covered by this Permit shall not deal with the GMOs except as expressly permitted by this Permit.
- 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, collection of GMO specimens, monitoring, inspecting the dealing or enforcement by the Agency.
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.
- The only plants that may be grown at a Planting Area are:
- the GMOs covered by this Permit as described in Attachment A of the Permit;
- plants approved in writing by the Agency.
- Planting and growing of the GMOs may only occur within the following limits:
Area and duration
|Maximum size of any Planting Area||Duration|
|2900 sq metres|
States in which Planting Areas may be located
- Plant Material shall not be used, sold or otherwise disposed of for any purpose which would involve or result in its use as food for humans or feed for animals.
- Cassava plant derived from the GMO may not be sold as a commercial product.
- 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 Planting Area prior to post-harvest Cleaning; or
- a facility approved in writing by the Agency.
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
- The trial site shall be adequately secured with:
- perimeter fence of wire mesh/gauze;
- 24-hour security personnel;
- clearly written sign posts at the four corners of the perimeter fence indicating CFT site of the GMOs.
- A Planting Area shall be:
- surrounded by a Pollen Trap; or
- surrounded by a Monitoring Zone and an Exclusion Zone.
- If a Pollen Trap is used in accordance with the previous condition, Pollen Trap Plants shall:
- have a reasonably dense and vigorous growth; and
- be Flowering at the same time as the GMOs; and
- 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.
- If a Monitoring Zone and an Exclusion Zone are used in accordance with condition 27:
- 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 cassava plants; and
- the GMOs shall not be planted in a Planting Area if any cassava plant, other than a crop planted pursuant to this permit is present in the Exclusion Zone; and
- 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 Cassava||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
- The outer edge of a Planting Area, and of a Pollen Trap if used, shall be at least 50 m away from Waterways.
- Isolation distance from related non-GMO species should not be less than 100meters.
- All Cassava 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 Cassava plants grown in a Planting Area or Pollen Trap.
- The GMOs shall be harvested separately from any other crop.
- 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.
- Roots from the GMOs shall be dealt with separately from any other root.
- 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.
- Any Equipment used in connection with the GMOs shall be cleaned as soon as practicable and before use for any other purpose.
- 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
- Transport and storage of GMOs outside the Planting Area shall:
- only occur to the extent necessary to conduct the dealings permitted by this Permit or other valid authorisation; and
- be in accordance with the Agency’s Guidelines for the Transport, Storage and Disposal of GMOs or
- if harvested Plant Material is transported in a bag shall be:
- completely wrapped in cellophane; or
- completely enclosed within metal/plastic container;
- 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 import the GMOs to the destination country.
- 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
- 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.
- Details of any inspection activity shall be recorded in a Logbook and shall include:
- date of the inspections;
- name of the person(s) conducting the inspections;
- details of the experience, training or qualification that enables the person(s) to recognise Volunteers, if not already recorded in the logbook;
- details of areas inspected including current land use and recent management practices applied;
- details of any post-harvest rainfall events including measurements at or near the area, or any irrigation events;
- details of any Volunteers observed including number, developmental stage and approximate position of the Volunteers within each area inspected and
- 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.
- While post-Cleaning inspection requirements apply to an area:
- the area shall be maintained in a manner appropriate to allow identification of Volunteers; and
- no plants may intentionally be grown in the area unless the plants are:
- the GMOs and non-GM cassava planted in accordance with the conditions of this permit; or
- listed as post-harvest crops permitted for the GM cassava field trial site by the Agency; or
- agreed to in writing by the Agency.
- If any unintentional presence of the GMOs is detected outside the areas requiring inspection, the Contingency Plan shall be implemented, which include:
- Notification of the Agency
- incident and corrective action forms shall be completed for each case of accidental release.
- The incorporation of the completed incident and corrective action forms into the compliance binder maintained at the CFT site.
- 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.
- 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.
- 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.
- The Permit Holder may make written application to the Agency that planting restrictions and inspection conditions no longer apply to an area if:
- all post-Cleaning inspection activities have been conducted for at least 12 months on the area and all associated areas of land; and
- 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.
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.
- Notifications shall be sent to the Agency as follows:
|(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|
After a thorough analysis of the application dossier, risk mitigation and contingency options available, it is unlikely that the proposed confined field trial would cause adverse impact on the environment and on human health. A permit is therefore granted to the International Institute of Tropical Agriculture (IITA), with REF CODE: NBMA/CFT/005.
This permit is with effect from 22nd day of September 2017 and terminates on the 31st day of December 2018.
|Signature and Date:
…………………………… 22nd September 2017
REF CODE: NBMA/CFT/005
Full Title: Limited and controlled release of cassava genetically modified for post-harvest reduction in starch breakdown
Postal address: International Institute of Tropical Agriculture,
PMB 5320, Oyo Road 200001,
Phone No: +234 700800IITA
GMOs covered by this Permit:
Manihot esculenta crantz containing only the events and genes listed below.
Common Name: Cassava
Scientific Name: Manihot esculenta crantz
Selectable marker – hptII
Description: Cassava plants have been genetically modified with introduced genes conferring silencing to storage roots reducing starch break down after pruning
Genes and events responsible for conferring the modified traits:
Genes: αRNAi gene
Events: CV60444 cassava cultivar.
Purpose of the dealings with the GMOs:
The purpose of the field trial is a proof of consent to assess reduction in starch breakdown in storage roots of cassava after pruning the shoots prior to harvest in the field.
DIR No: REF CODE NBMA/CFT/005
Checklist of documents that shall be sent to the Agency:
|Prior to conducting any dealings||Details of persons covered||14 days prior to any planting|
|Preparation of Standard Operating Procedure (SOP)||14 days before commencement of the CFT|
|Location of and approval CFT sites||At least 30 days after issuance of permit and before planting|
|Plan to inform persons covered by the permit||14 days prior to any planting|
|Plan to ensure control and access to all the Sites||14 days prior to any planting|
|Detection methodology||14 days prior to any planting|
|Contingency plan||14 days prior to any planting|
|Prior to planting||Intention to plant||At least 7 days prior to any planting|
|During growing||Planting||Within 7 days of any planting|
|Pruning||From 7 months to allow for proper bulking and subsequent analysis|
|Harvest||Within 7 days of commencement|
|Post-Cleaning||Cleaning||Within 7 days of completion|
|Inspection||Within 35 days of each inspection|
|Fallowing||At least one year|
|Any time after issue of the Permit||Any changes of the project supervisor contact details||As soon as practically possible|
|Any relevant conviction, revocation, suspension or cancellation of any relevant permit or circumstances that may affect compliance to licence conditions||Immediately, if occurs|
|Any information relevant to on-going suitability||If and when requested|
|Any changes to details provided under conditions 10(a) – 10(e)||Within 14 days of the changes|
|Signed statements from persons covered under the licence||If and when requested|
|Any additional information regarding health and safety of the people and the environment, contraventions of this licence or any unintended effects of the dealings authorized by the licence||As soon as practically and reasonably possible, after becoming aware|
|Extreme weather conditions||As soon as practically and reasonably possible, if expected or occurs
|Methods and procedures for transport||If and when requested|