ANNEXURE 1
INFORMATION TO BE CONTAINED IN TRANSPORT DOCUMENTS
1.Every transport document to which these regulations apply must contain the following information-(a)Information that the GMO is intended for genetically modified food or feed or contained use and the type of activity or activities relevant to the placing on the market or contained use;(b)a description of the relevant GMO, including common, scientific and (if in use as such) commercial names of the GMO as well as the total quantity of GMO being transported;(c)instructions for safe handling, storage, transport and use;(d)risk category according to the risk category system determined by the Council, if any;(e)unique identification bar code;(f)the contact details where further information, including technical information, can be obtained in English by any person, including the contact details of the exporter and importer if applicable;(g)the approved emergency response plan;(h)the name and address of the place of business of the transporter;(i)the date of the transport document;(j)a copy of the relevant permit, if applicable;(k)the name and contact details of the person who is to receive the GMO;(l)the physical address to where the GMO is to be delivered; and(m)if the quantity of the GMO, or the number of containers in which the GMO is transported, changes during transport, the transporter must show such change on the transport document.2.Item 1(a), (b), (f), (g), (h), (i), (j), (k) and (l) apply with the necessary changes to GMO products.ANNEXURE 2
INFORMATION REQUIRED, UNDER REGULATION 21(3), TO ACCOMPANY APPLICATION FOR CERTIFICATE TO REGISTER FACILITY
Part 1 – INFORMATION REQUIRED WITH REGARD TO ALL CERTIFICATE APPLICATIONS
SECTION A: DETAILS RELATING TO FACILITY AND CONTAINED USE ACTIVITIES
1.Full details of facility where the activity is to be conducted including postal and physical address and description of location facility2.Personal details of person(s) responsible for the work relating to the activity including name of person(s) and qualifications3.Description of the facility including the layout thereof and construction material4.Details on waste management including the waste to be generated, their treatment, final form and destination5.Accident prevention procedures and plans and emergency response plans6.Safety of personnel procedures and plans7.Risk assessment report and risk management plan8.List of responsible personnel/persons including names, qualifications and responsibilities9.The type of contained use activity or activities involvedThe above information must be provided with regard to each facility to which the application relates.SECTION B: DECLARATION
Declaration by responsible person submitting application that information provided is factually correct and truthful.SECTION C: APPLICANT AND GMO INFORMATION
1.Name of applicant and postal, physical and email address2.Relevant facility (if applicable)3.The purpose of the genetic modification (brief description of proposed activities) and the containment levels involved4.List of the GMO(s) involved or intended to be involvedThe above information must be provided with regard to each facility to which the application relates.PAR 2 – INFORMATION REQUIRED WITH REGARD TO APPLICATION FOR A CERTIFICATE FOR FIRST TIME USE OF FACILITY
SECTION A
1.The names of the persons responsible for supervision and safety and detailed information on their training and qualifications2.The recipient, donor and/or parental micro-organism(s) used and, where applicable, the hostvector system(s) used3.The source(s) and the intended function(s) of the genetic material(s) involved in the modification(s)4.Identity and characteristics of the GMO5.The purpose of the contained use including the expected results6.Approximate culture volumes to be used7.Description of the containment measures to be applied, including detailed containment information about waste management and the waste to be generated, their treatment, final form and destination8.The information necessary for the Council to evaluate any emergency response plans, if requiredThe above information must be provided with regard to each facility to which the application relates.SECTION B
1.The names of the persons responsible for supervision and safety and information on their training and qualifications2.The recipient or parental micro-organism to be used3.The host-vector system to be used (where applicable)4.The source and intended function of the genetic material involved in the modification5.Identity and characteristics of the GMO6.The culture volumes to be used7.Description of the containment measures to be applied, including information about waste management including the type and form of waste to be generated, their treatment, final form and destination8.The purpose of the contained use including the expected results9.Description of the parts of the premises10.Information about accident prevention and emergency response plans, if any11.Any specific hazards arising from the location of the premises12.The preventive measures applied such as safety equipment, alarm systems and14.Procedures and plans for verifying the continuing effectiveness of the containment measures15.A description of information provided to workers16.he information necessary for the competent authority to evaluate any emergency17.Response plans if required18.A copy of the risk assessment, risk management plan and risk assessment reportThe above information must be provided with regard to each facility to which the application relates.ANNEXURE 3
PRINCIPLES FOR RISK ASSESSMENT, RISK ASSESSMENT REPORT AND RISK MANAGEMENT PLAN
Part 1 – OBJECTIVES AND PRINCIPLES
1.This Annexure 4 describes, in general terms, the objective to be achieved, the elements to be considered and the general principles and methodology to be followed in undertaking a risk assessment and preparing a risk management plan and risk assessment report required by these regulations.2.It is an objective of a risk assessment under these regulations to, on a case-by-case basis, to identify and evaluate potential adverse effects of a GMO, either direct or indirect, immediate or delayed, on the health or safety of humans or animals or the environment. The risk assessment must be conducted with a view to identify the need for, and the extent of, a risk management plan and, if so, the most appropriate methods to be used.3.A general principle for risk assessment is that an analysis of the cumulative long-term effects relevant to an introduction into the environment (including placing on the market) is to be carried out.4.In accordance with the precautionary principle, the following general principles should be followed when performing the risk assessment:(a)Identified characteristics of the GMO and its use which have the potential to cause adverse effects should be compared to those presented by the non-modified organism from which it is derived and its use under corresponding situations;(b)the risk assessment must be carried out in a scientifically sound and transparent manner based on available scientific and technical data;(c)the risk assessment must be carried out on a case-by-case basis, meaning that the required information may vary depending on the type of GMO concerned, its intended use and the potential receiving environment, taking into account, amongst others, GMOs already in the environment;(d)if new information on the GMO and its effects on the health or safety of humans or animals or the environment becomes available, the risk assessment may need to be re-addressed in order to determine whether -(i)the risk has changed; and(ii)there is a need for amending the risk management accordingly.Part 2 – INTERPRETATION
1.With a view to contributing to a common understanding of the terms “direct”, “indirect”, “immediate” and “delayed” when implementing this Annexure, without prejudice to further guidance in this respect and in particular as regards the extent to which indirect effects can and should be taken into account, these terms are described as follows:(a)“direct effects” refer to primary effects on the health or safety of humans or animals or the environment which are a result of the GMO itself and which do not occur through a causal chain of events;(b)“indirect effects” refer to effects on the health or safety of humans or animals or the environment occurring through a causal chain of events through mechanisms such as interactions with other organisms, transfer of genetic material or changes in use or management. Observations of indirect effects are likely to be delayed;(c)“immediate effects” refer to effects on the health or safety of humans or animals or the environment which are observed during the period of the introduction into the environment of the GMO. Immediate effects may be direct or indirect;(d)“delayed effects” refer to effects on the health or safety of humans or animals or the environment which may not be observed during the period of the introduction into the environment of the GMO but become apparent as a direct or indirect effect either at a later stage or after termination of the introduction into the environment.2.In this Annexure the expression-(a)“cumulative long-term effects” refers to the accumulated effects of approvals on the health or safety of humans or animals or the environment including, amongst others but not limited to, flora and fauna, soil fertility, soil degradation of organic material, the feed or food chain, biological diversity and resistance problems in relation to antibiotics;(b)“genetically modified higher plants” means plants in which the genetic material was modified in a way which does not occur in the environment or which is not the result of natural recombination;(c)“introduction into the environment” means any release into the environment of a GMO for whatever reason;3.In terms of the Environmental Management Act an assessment report and environmental clearance certificate is required for the environmental release of a GMO into the environment. In order to facilitate that the risk assessment anticipated in this Annexure is also compliant with the requirements for an assessment report under the Environmental Management Act, this Annexure specifically also incorporates the requirements for an assessment report under that Act with regard to a risk assessment undertaken under these regulations.Part 3 – RISK ASSESSMENT METHODS AND RISK MANAGEMENT PLAN
1.Depending on the relevant case, the risk assessment must take into account the relevant technical and scientific details regarding characteristics of:(a)The recipient or parental organism(s);(b)the genetic modification or modifications, be it inclusion or deletion of genetic material, and relevant information on the vector and the donor;(d)if applicable, the intended introduction into the environment or use including its scale;(e)the potential receiving environment; and(f)the interaction between these.2.In drawing conclusions for the risk assessment, the identification of characteristics which may cause adverse effects must be addressed.3.Any characteristics of the GMO linked to the genetic modification which may result in adverse effects on the health or safety of humans or animals or the environment must be identified.4.The inclusion of a comparison of the characteristics of the GMO with those of the non-modified organism under corresponding conditions of its introduction into the environment or use will assist in identifying the particular potential adverse effects arising from the genetic modification.5.Potential adverse effects on the basis that they are unlikely to occur must not be discounted.6.Potential adverse effects of a GMO will vary from case to case and may include but are not limited to the following:(a)Disease to humans including allergenic or toxic effects;(b)disease to animals and plants including toxic, and where appropriate, allergenic effects;(c)effects on the dynamics of populations of species in the receiving environment and the genetic diversity of each of these populations;(d)altered susceptibility to pathogens facilitating the dissemination of infectious diseases or creating new reservoirs or vectors;(e)compromising prophylactic or therapeutic medical, veterinary or plant protection treatments, for example by transfer of genes conferring resistance to antibiotics used in human or veterinary medicine;(f)effects on biogeochemistry (biogeochemical cycles), particularly carbon and nitrogen recycling through changes in soil decomposition of organic material.7.Adverse effects may occur directly or indirectly through mechanisms which may include but are not limited to the following:(a)The spread of the GMO in the environment;(b)the transfer of the inserted genetic material to other organisms, or the same organism whether genetically modified or not;(c)phenotypic and genetic instability;(d)interactions with other organisms;(e)changes in management including, where applicable, in agricultural practices.8.The risk assessment must include an evaluation of the potential consequences of each adverse effect, should it occur, and in such case -(a)the magnitude of the consequences of each potential adverse effect must be evaluated; and(b)this evaluation must assume that such an adverse effect will occur. The magnitude of the consequences is likely to be influenced by the environment into which the GMO is introduced and the manner of the eintroduction.9.The risk assessment must include an evaluation of the likelihood of the occurrence of each identified potential adverse effect and in this regard a major factor in evaluating the likelihood or probability of adverse effects occurring is the characteristics of the environment into which the GMO is to be introduced and the manner of the e introduction.10.An estimation of the risk to the health and safety of humans or animals or the environment posed by each identified characteristic of the GMO which has the potential to cause adverse effects should be made as far as possible by combining the likelihood of the adverse effect occurring and the magnitude of the consequences, should it occur.11.An estimation of the risk posed by each identified characteristic of the GMO must be included in the risk assessment.12.The risk assessment must identify risks which require management and how best to manage them and a risk management strategy must be defined.13.A determination of the overall risk of the GMO must be included in the risk management plan. In this regard an evaluation of the overall risk of the GMO must be made taking into account any risk management strategies which are proposed.14.On the basis of a risk assessment carried out in accordance with the principles and methodology outlined in this Annexure, information contained herein must be included, as appropriate, in the risk assessment plan with a view to assisting in drawing conclusions on the potential environmental impact from the introduction into the environment (including the placing on the market) of a GMO.15.In the case of GMOs other than higher plants the risk assessment must cover/identify (based on what follows select right word here)-(a)the likelihood of the GMO to become persistent and invasive in natural habitats under the conditions of the environmental introducction;(b)any selective advantage or disadvantage conferred to the GMO and the likelihood of this becoming realised under the conditions of the environmental introduction;(c)the potential for gene transfer to other species under conditions of the environmental introduction of the GMO and any selective advantage or disadvantage conferred to those species;(d)the potential immediate and delayed environmental impact of the direct and indirect interactions between the GMO and target organisms, if applicable;(e)the potential immediate and delayed environmental impact of the direct and indirect interactions between the GMO with non-target organisms including impact on population levels of competitors, prey, hosts, symbionts, predators, parasites and pathogens;(f)all possible immediate and delayed effects on human health and safety resulting from potential direct and indirect interactions of the GMO and persons working with, coming into contact with or in the vicinity of the GMO when introduced into the environment;(g)all possible immediate and delayed effects on animal health and safety and consequences for the feed and food chain resulting from consumption of the GMO and any product derived from it, if it is intended to be used as animal feed;(h)all possible immediate and delayed effects on biogeochemical processes resulting from potential direct and indirect interactions of the GMO and target and non-target organisms in the vicinity of the GMO when introduced into the environment;(i)all possible immediate and delayed, direct, and indirect environmental impacts of the specified cultivation, management and harvesting techniques used for the management of the GMO where these are different from those used for non-genetically modified organisms.16.The risk management plant must include all bibliographic references and details of the methods used.17.Upon completion of the risk assessment, the risk management plan must -(a)be drawn up taking due consideration of the risk assessment and outcomes thereof and incorporating into the risk management plan the matters that are relevant to be managed; and(b)include an overview of the risk assessment setting out amongst others the manner in which the risk assessment was conducted, all matters addressed during such assessment and the outcomes thereof;(c)have attached thereto the relevant risk management records including the risk assessment report.Part 4 – GUIDELINES FOR THE RISK ASSESSMENT REPORTS
1.Without derogating from any other Part of this Annexure, a risk assessment report prepared in accordance with these regulations must in particular include the following-(a)the matters set out in section 23(2)(b) of the Act;(b)identification of any known risks to the health or safety of humans or animals or the environment resulting from introduction of the GMO into the environment of the non-modified organism;(c)an assessment of whether the genetic modification is characterised sufficiently for the purpose of evaluating any risks to the health and safety of humans and animals and the environment;(d)identification to any new risks to the health and safety of humans and animals and the environment which may arise from the introduction to the environment of the GMO or GMOs in question as compared to the introduction into the environment of the corresponding non-modified organism or organisms based on the risk assessment carried out in accordance with this Annexure;(e)if applicable an assessment on whether the GMO or GMOs in question can be placed on the market and under which conditions or whether the GMO or GMOs in question must not be placed on the market.2.The risk assessment report must include the application of management strategies for risks from the introduction into the environment of the GMO.3.The risk assessment report must identify risks which require management and how best to manage them and a risk management strategy must be defined.Part 5 – MONITORING
1.This Part 5 describes in general terms the objectives to be achieved and the general principles to be followed in designing a monitoring plan and in monitoring GMO or GMO product dealings and activities. The latter may be supplemented by guidelines developed by the Council under section 15(d) of the Act.2.Unless not required under these regulations, the holder of a permit must at all times have in place, implement and comply with a monitoring plan as part of the risk management plan in accordance with this Annexure.3.A permit holder must, at or within the time intervals specified in the monitoring plan, submit the reports specified in the monitoring plan to the Council.4.A monitoring plan must-(a)be detailed, on a case-by-case basis, taking into account the relevant risk assessment;(b)indicate the time period of the monitoring plan;(c)include an obligation to report on the monitoring to the Council and such other authorities or entities as the Council may determine; and(d)where appropriate, set out the obligations on a person selling the product or any user of it, which may include an obligation to provide information at an appropriate level on the location at which the GMO concerned is grown.(e)take into account the characteristics of the GMO, the characteristics and scale of its intended use and the range of relevant environmental conditions where the GMO is expected to be introduced into the environment;(f)incorporate general surveillance for unanticipated adverse effects and, if necessary, include case-specific monitoring focusing on adverse effects identified in the risk assessment since case-specific monitoring should be carried out for a sufficient time period to detect immediate and direct as well as, where appropriate, delayed or indirect effects which have been identified in the risk assessment -(g)facilitate the observation, in a systematic manner, of the environmental introduction of a GMO in the receiving environment and the interpretation of these observations with respect to the health and safety of humans and animals and the environment;(h)identify who will carry out the various tasks the monitoring plan requires and who is responsible for ensuring that the monitoring plan is set into place and carried out appropriately, and ensure that there is a route by which the permit holder and the Council will be informed of any observed adverse effects on human and animal health and safety and the environment;(i)give consideration to the mechanisms for identifying and confirming any observed adverse effects on human and animal health and safety and the environment and enable the permit holder or the Council, where appropriate, to take the measures necessary to protect human and animal health and safety and the environment.5.Monitoring must, if appropriate, make use of already established routine monitoring practices such as the monitoring of agricultural cultivars, plant protection, or veterinary and medical products. An explanation must be provided as to how relevant information collected through established routine surveillance practices will be made available to the permit holder;6.The Council may request an applicant or permit holder to amend the applicant’s or permit holder’s monitoring plan in such manner as deemed appropriate by the Council in order to achieve the objectives of the Act.7.In the event of an environmental release, the environmental release permit holder must, at such intervals as set out in the holder’s permit or as determined by the Council, submit a report to the Council on the results of the environmental release.8.The report contemplated in item 7 must be in such format as determined by the Council, and must include at least a post-release evaluation of the risks to the health and safety of humans and animals and the environment.9.Monitoring takes place after the introduction into the environment of a GMO.10.The interpretation of the data collected by monitoring must be considered in the light of other existing environmental conditions and activities. Where changes in the environment are observed further assessment must be considered to establish whether they are a consequence of the GMO, or its use, as such changes may be the result of environmental factors.Part 6 – REQUIREMENTS FOR ASSESSMENT REPORT UNDER THE ENVIRONMENTAL MANAGEMENT ACT
1.In so far as such are not required in Parts 1 to 5 of this Annexure, the following requirements, as set out in the Environmental Impact Assessment Regulations and pertaining to the assessment report under the Environmental Assessment Regulations, apply to a risk assessment undertaken under these regulations and must be included in the risk management plan and risk assessment report:(a)The curriculum vitae of the environmental assessment practitioner who compiled the assessment report in accordance with the Environmental Impact Assessment Regulations;(b)a detailed description of the proposed listed activity;(c)a description of the environment which may be affected by the activity and the manner in which the physical, biological, social, economic and cultural aspects of the environment may be affected by the proposed activity;(d)a description of the need and desirability of the proposed listed activity and identified potential alternatives to the proposed listed activity, including advantages and disadvantages that the proposed activity or alternatives may have on the environment and the community that may be affected by the activity;(e)an indication of the methodology used in determining the significance of potential effects;(f)a description and comparative assessment of all alternatives identified during the assessment process;(g)a description of all environmental issues which were identified during the assessment process, an assessment of the significance of each issue and an indication of the extent to which the issue could be addressed by the adoption of mitigation measures;(h)an assessment of each identified potentially significant effect, including -(bb)the nature of the effects;(cc)the extent and duration of the effects;(dd)the probability of the effects occurring;(ee)the degree to which the effects can be reversed;(ff)the degree to which the effects may cause irreplaceable loss of resources; and(gg)the degree to which the effects can be mitigated;(i)a description of any assumptions, uncertainties and gaps in knowledge;(j)an opinion as to whether the proposed listed activity must or may not be authorised, and if the opinion is that it must be authorised, any conditions which must be made in respect of that authorisation;(k)a non-technical summary of the information; and(l)such additional information which may be required under the Environmental Impact Assessment Regulations to be included in the assessment report under those Regulations.ANNEXURE 4
FEES
| Regulation | Nature of Fee | Fee |
|---|
| 6(4) | Application fee for a permit to place on the market genetically modified food or feed | N$1 000 |
| 26(4) | Application fee for a contained use permit | N$1 000 |
| 21(2) | Application fee for registration of facility | N$1 000 |
| 44(2) | Application fee for an environmental release permit | N$1 000 |
| 35(2) | Application fee for field trial permit | N$1 000 |
| 8(1) | Issue fee for placing on the market permit | N$5 000 |
| 28(1) | Issue fee for contained use permit | N$5 000 |
| 23(2) | Issue fee for registration of facility certificate | N$10 000 |
| 47(1) | Issue fee for environmental release or field trial permit | N$5 000 |
| 37(1) | Issue fee for field trial permit | N$5 000 |
| 9(2) | Annual renewal fee for placing on the market permit | N$1 000 |
| 29(2) | Annual renewal fee for contained use permit | N$500 |
| 24(2) | Annual renewal fee for certificate | N$500 |
| 48(2) | Annual renewal fee for environmental release permit | N$500 |
| 38(2) | Annual renewal fee for field trial permit | N$500 |
| 14(2) | Fee for inspection of genetically modified food or feed arriving in Namibia | N$5 000 |
