Regulations relating to impact assessment pursuant to the Gene Technology Act

The translation is not official; it is provided for information purposes only. In the event of any inconsistency, the Norwegian version shall prevail.

Chapter 1. General provisions

§ 1. Scope

These regulations govern the content and processing of impact assessments required for deliberate release of genetically modified organisms that is subject to the duty to obtain approval pursuant to section 10, cf section 11, of the Gene Technology Act. They also govern the duty of applicants to carry out investigations during and after deliberate release in order to elucidate its effects, and to report to the authority responsible for granting approval (the competent authority) on the results of such investigations.

The regulations also apply if an impact assessment is required in connection with approval of contained use pursuant to section 8 of the Gene Technology Act.

§ 2. The purpose of impact assessment and the duty to carry out investigations and provide reports

Impact assessment pursuant to the Gene Technology Act is intended to provide a basis for assessing the risk of adverse effects on the environment or human or animal health and other consequences of projects for which approval is mandatory. An impact assessment is intended to ensure that an applicant takes any such effects into account before carrying out a project and that the competent authority has the best possible basis for determining whether and on what conditions to grant approval.
Investigations are intended to confirm that assumptions about the occurrence and magnitude of potential adverse effects of a genetically modified organism or its use are correct, and to identify any adverse effects that were not foreseen in the impact assessment.

Reporting is intended as a means of ensuring that approval for deliberate release and, if appropriate, the conditions on which approval is granted, are altered if new information so indicates.

§ 3. Competent authorities

The competent authority for deliberate release pursuant to section 10 of the Gene Technology Act is the Ministry of the Environment or the instance so authorised by the Ministry. The competent authority for approval for contained use pursuant to section 7, cf section 8, of the Gene Technology Act is the Ministry of Health and Care Services or the instance so authorised by the Ministry.

Chapter 2. Administrative procedures

§ 4. Impact assessment in connection with applications for deliberate release

An impact assessment for the project shall be submitted at the same time as an application for the approval of deliberate release pursuant to section 10, cf section 11, of the Gene Technology Act. The competent authority shall give the applicant written confirmation of the date on which the application and impact assessment were received.

§ 5. Impact assessment in connection with applications for contained use

If the competent authority decides to require impact assessment of any unintended release of genetically modified organisms in connection with contained use pursuant to section 8 of the Gene Technology Act, this requirement shall be laid down without any unnecessary delay after receipt of the application.

A decision to require impact assessment pursuant to section 8 of the Gene Technology Act may not be appealed.

§ 6. Duty of the applicant to provide information

After an impact assessment has been submitted to the competent authority and until a decision has been made regarding the application, the applicant has a duty to inform the said authority of any new information that may be of importance for its decision.

§ 7. Requirement to provide additional information

If the competent authority finds that the impact assessment does not provide an adequate basis for making a decision regarding an application, the applicant may be required to obtain further information and carry out further investigations, cf section 11, second paragraph, of the Gene Technology Act. Grounds shall be given for such a requirement.

§ 8. Time limit for processing applications for deliberate release pursuant to section 9, second paragraph, litrae a-e, and section 10 of the Gene Technology Act

The competent authority shall make a decision pursuant to section 10, first paragraph, cf section 10, second paragraph, of the Gene Technology Act, and Chapter 4 of these regulations, no later than 90 days after receipt of an application.

For the purpose of calculating the 90-day period referred to in the first paragraph, no account shall be taken of any period when the competent authority:

• is awaiting further information it has requested from the applicant,
• is holding a public consultation, cf section 13 of the Gene Technology Act. A public consultation shall not prolong the 90-day period referred to in the first paragraph by more than 30 days.

§ 9. Time limit for processing applications for deliberate release pursuant to section 9, second paragraph, litra f, and section 10 of the Gene Technology Act

The competent authority shall draw up an assessment report that is sent to the applicant no later than 90 days after receipt of the application. At the same time, the authority shall:

1. inform the applicant that the application for deliberate release has been sent to the other EEA states for comment together with a recommendation that it should be approved, or
2. inform the applicant that the application has been refused because the deliberate release does not satisfy the requirements of section 10, first and second paragraphs, of the Gene Technology Act, cf Chapter 4 of these regulations.

For the purpose of calculating the 90-day period referred to in the first paragraph, no account shall be taken of any period when the competent authority is awaiting further information it has requested from the applicant.

In cases such as are mentioned in the first paragraph, litra a, the applicant shall be informed about the decision no later than 30 days after processing of the application has been completed in accordance with the rules of the EEA Agreement, Annex XX, subsection 25, cf. Protocol 1 to the EEA Agreement.

§ 10. Time limit for processing applications for contained use pursuant to section 7, cf section 8, of the Gene Technology Act

The time limit for processing applications for contained use is set out in regulations laid down pursuant to section 7 of the Gene Technology Act.

§ 11. Referral to the Norwegian Biotechnology Advisory Board

The competent authority may refer an impact assessment to the Norwegian Biotechnology Advisory Board for evaluation and an opinion before making a decision, see section 26 of the Gene Technology Act.

Chapter 3. Form of impact assessments

§ 12. Requirements relating to the form of impact assessments

An impact assessment shall be submitted in the form of a single coordinated document.

To ensure that the impact assessment is suitable for consideration by the public authorities, scientific terms shall be defined or explained to the extent necessary, and the assessment shall include a readily understandable summary.

The impact assessment shall contain references to relevant background material, which shall be available to the competent authority.

Chapter 4. Content of impact assessments

§ 13. Impact assessment in the case of a first application for deliberate release for the purpose of placing on the market pursuant to section 9, second paragraph, litra f, and section 10 of the Gene Technology Act

To the extent necessary and practicable, an impact assessment shall give a description of the project in question and an account of the risk and magnitude of any adverse effects on the environment or human or animal health that may arise as a result of the project or any unintended release of genetically modified organisms from the project. The description shall include the information listed in Appendix 1 and an environmental risk assessment in accordance with Appendix 2.

An impact assessment shall specify which safeguard measures have been or will be taken to prevent the project from having adverse effects on the environment or human or animal health.

An impact assessment shall also include a monitoring plan and a proposal for the time period of the plan in accordance with the requirements set out in Appendix 3, and a proposal for labelling and packaging in accordance with the requirements of section 15 of the Regulations of 2 September 2005 No. 1009 relating to the labelling, transport, import and export of genetically modified organisms, and with Appendix 4. For genetically modified organisms that are to be used as or in food or feed, the proposal for labelling shall be in acordance with the requirements of the Regulations of 21 December 1993 No. 1385 relating to the labelling, etc., of food, or the Regulations of 7 November 2002 No. 1290 relating to feed.

In addition, an impact assessment shall specify the conditions proposed by the applicant for placing on the market, including special requirements of use and handling, and a proposal for the time period for which approval should be valid in accordance with section 18 below.

Furthermore, an impact assessment shall describe results and experience from previous projects involving deliberate release that are relevant to the application.

§ 14. Impact assessment in the case of an application for renewal of approval for deliberate release for the purpose of placing on the market pursuant to section 9, second paragraph, litra f, and section 10 of the Gene Technology Act

An impact assessment shall contain a copy of the current approval document, a report on the results of monitoring carried out in accordance with section 13, third paragraph, and section 18, first paragraph, of these regulations, all other new information available on the risk of adverse effects on human or animal health or the environment associated with the genetically modified organism(s), and, if appropriate, a proposal to alter or supplement the conditions in the original approval or supplementary conditions, including conditions relating to further monitoring and the time limit for which approval is valid.

§ 15. Impact assessment in the case of an application for deliberate release pursuant to section 9, second paragraph, litra a to e, and section 10 of the Gene Technology Act

To the extent necessary and practicable, an impact assessment shall give a description of the project in question and an account of the risk and magnitude of any adverse effects on the environment or human or animal health that may arise as a result of the project or any unintended release of genetically modified organisms from the project. The description shall include any information listed in Appendix 1 that is necessary for carrying out an impact assessment for the project in question, especially:

1. general information, including information on personnel and training,
2. information relating to the genetically modified organism(s) in question,
3. information relating to the conditions of release and the potential receiving environment,
4. information on interactions between the genetically modified organism(s) to which the application for approval applies and the environment,
5. a monitoring plan in accordance with the relevant parts of Appendix 1 in order to identify effects of the genetically modified organism(s) in question on human or animal health or the environment,
6. information on control, remediation methods, waste treatment and emergency response plans, and
7. a summary of the technical dossier.

An impact assessment shall also include an environmental risk assessment in accordance with Appendix 2, together with any bibliographic reference and indications of the methods of risk assessment used.

§ 16. Impact assessment pursuant to section 8 of the Gene Technology Act

To the extent necessary and practicable, an impact assessment shall give a description of the project in question and an account of the risk and magnitude of any adverse effects on the environment or human or animal health that may arise as a result of the project or any unintended release of genetically modified organisms from the project. The competent authority for contained use will determine whether and to what extent Appendices 1-4 are applicable to such impact assessments. Such decisions may not be appealed.

An impact assessment shall further describe the emergency measures, including any cleaning or disinfection methods, that can be implemented to limit or mitigate adverse effects on the environment or human or animal health of the unintended release or spread of the genetically modified organisms.

An impact assessment shall further set out the plans for post-release treatment of production equipment and/or the area that may be affected by an unintended release, and plans for waste treatment.

§ 17. Other consequences of the production and use of genetically modified organisms

To the extent necessary and practicable, an impact assessment shall in accordance with Appendix 4 give an account of other consequences of the project than those on the environment and human and animal health, including:

1. positive or negative effects of the project in relation to sustainable development,
2. ethical considerations that may arise in connection with the use of the genetically modified organism(s), and
3. any favourable or unfavourable social consequences that may arise from the use of the genetically modified organism(s).

Chapter 5. Conditions for approval, period of validity of approval and the content of decisions on approval of projects

§ 18. Conditions for approval and period of validity of approval

The competent authority shall as a condition of granting approval require the applicant to report to the said authority on the result of the release, and may require the applicant to carry out further investigations during and after the project to determine its effects in practice, cf section 15 of the Gene Technology Act, section 13, third paragraph and section 15, first paragraph, litra e, above, and section 19, litra f and Appendix 3 below.

Approval for placing genetically modified organisms on the market for the first time shall not be granted for a period of more than 10 years, cf section 15 of the Gene Technology Act.

In the case of an application for renewal of approval, marketing may continue in accordance with the approval previously granted until the application for renewal has been decided. Applications for renewal of approval granted pursuant to section 19, sixth paragraph, of the Gene Technology Act before 17 October 2002 must be submitted by 17 October 2006.

§ 19. Content of decisions on approval pursuant to section 9, second paragraph, litra f, of the Gene Technology Act

A decision to approve an application shall explicitly specify:

1. the scope of the approval, including the identity of the genetically modified organism(s) to be place on the market as or in products, and their unique identification code,
2. the period of validity of the approval,
3. the conditions for the placing on the market of the product, including any specific conditions of use, handling and packaging of products that consist of or contain genetically modified organisms, and conditions for the protection of particular ecosystems/environments and/or geographical areas,
4. that the applicant shall make control samples available to the competent authority on request,
5. labelling requirements in accordance with the requirements laid down in the Regulations of 2 September 2005 No. 1009 relating to the labelling, transport, import and export of genetically modified organisms and Appendix 1, part C of these Regulations, or, for genetically modified organisms that are to be used as or in food or feed, in accordance with the requirements of the Regulations of 21 December 1993 No. 1385 relating to the labelling, etc of food or the Regulations of 7 November 2002 No. 1290 relating to feed.
6. monitoring requirements in accordance with Appendix 3, including obligations to report, the time period of the monitoring plan, and, where appropriate, any obligations on any person selling the product or any user of it, including, in the case of the genetically modified organisms that are grown, concerning a level of information deemed appropriate on their location.

Chapter 6. Entry into force

§ 20. Entry into force

These regulations enter into force on 1 January 2006. From the same date, the Regulations of 20 August 1993 No. 816 relating to impact assessment pursuant to the Gene Technology Act are repealed.

Appendix 1 Information necessary in a description of the project for which approval is sought pursuant to sections 13-16 of the regulations

Introduction

Not all the points included will apply to every case. An individual application shall therefore address only the particular subset of considerations that is appropriate to the specific case.

The level of detail required in response to each subset of considerations is also likely to vary according to the nature and the scale of the proposed release.

Future developments in genetic modification may necessitate adapting this Appendix to technical progress or developing guidance notes on this Appendix. Further differentiation of information requirements for different types of genetically modified organisms, for example single-celled organisms, fish or insects, or for particular use of genetically modified organisms like the development of vaccines, may be possible once sufficient experience with notifications for the release of particular genetically modified organisms has been gained in the EEA.

The description of the methods used or the reference to standardised or internationally recognised methods shall also be mentioned in the dossier, together with the name of the body or bodies responsible for carrying out the studies.

Appendix 1 Part A applies to releases of all types of genetically modified organisms other than higher plants. Appendix 1 Part B applies to release of genetically modified higher plants.

The term ‘higher plants’ means plants which belong to the taxonomic group Spermatophytae (Gymnospermae and Angiospermae).

Part A Information required in applications concerning releases of genetically modified organisms other than higher plants

I. General information

1. Name and address of the applicant (company or institute)
2. Name, qualifications and experience of the responsible scientist(s)
3. Title of the project

II. Information relating to the genetically modified organism

A. Characteristics of the donor, the recipient or (where appropriate) parental organism(s):

1. Scientific name.
2. Taxonomy.
3. Other names (usual name, strain name, etc.).
4. Phenotypic and genetic markers.
5. Degree of relatedness between donor and recipient or between parental organisms.
6. Description of identification and detection techniques.
7. Sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques.
8. Description of the geographical distribution and of the natural habitat of the organism including information on natural predators, prey, parasites and competitors, symbionts and hosts.
9. Organisms with which transfer of genetic material is known to occur under natural conditions.
10. Verification of the genetic stability of the organisms and factors affecting it.
11. Pathological, ecological and physiological traits:
    a) classification of hazard according to existing rules concerning the protection of human health and/or the environment;
    b) generation time in natural ecosystems, sexual and asexual reproductive cycle;
    c) information on survival, including seasonability and the ability to form survival structures;
    d) pathogenicity: infectivity, toxigenicity, virulence, allergenicity, carrier (vector) of pathogen, possible vectors, host range including non-target organisms. Possible activation of latent viruses (proviruses). Ability to colonise other organisms;
    e) antibiotic resistance, and potential use of these antibiotics in humans and domestic organisms for prophylaxis and therapy;
    f) involvement in environmental processes: primary production, nutrient turnover, decomposition of organic matter, respiration, etc.
12. Nature of indigenous vectors:
    a) sequence;
    b) frequency of mobilisation;
    c) specificity;
    d) presence of genes which confer resistance.
13. History of previous genetic modifications.

B. Characteristics of the vector

1. Nature and source of the vector.
2. Sequence of transposons, vectors and other non-coding genetic segments used to construct the genetically modified organism and to make the introduced vector and insert function in the genetically modified organism.
3. Frequency of mobilisation of inserted vector and/or genetic transfer capabilities and methods of determination.
4. Information on the degree to which the vector is limited to the DNA required to perform the intended function.

C. Characteristics of the modified organism

1. Information relating to the genetic modification:

a) methods used for the modification;
b) methods used to construct and introduce the insert(s) into the recipient or to delete a sequence;
c) description of the insert and/or vector construction;
d) purity of the insert from any unknown sequence and information on the degree to which the inserted sequence is limited to the DNA required to perform the intended function;
e) methods and criteria used for selection;
f) sequence, functional identity and location of the altered/inserted/deleted nucleic acid segment(s) in question with particular reference to any known harmful sequence.

2. Information on the final genetically modified organism:

a) description of genetic trait(s) or phenotypic characteristics and in particular any new traits and characteristics which may be expressed or no longer expressed;
b) structure and amount of any vector and/or donor nucleic acid remaining in the final construction of the modified organism;
c) stability of the organism in terms of genetic traits;
d) rate and level of expression of the new genetic material. Method and sensitivity of measurement;
e) activity of the expressed protein(s);
f) description of identification and detection techniques including techniques for the identification and detection of the inserted sequence and vector;
g) sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques;
h) history of previous releases or uses of the genetically modified organism;
i) considerations of human health and animal health, as well as plant health:

i. toxic or allergenic effects of the genetically modified organisms and/or their metabolic products;
ii. ii comparison of the modified organism to the donor, recipient or (where appropriate) parental organism regarding pathogenicity;
iii. iii. capacity for colonisation;
iv. iv. if the organism is pathogenic to humans who are immunocompetent:

– diseases caused and mechanism of pathogenicity including invasiveness and virulence,
– communicability,
– infective dose,
– host range, possibility of alteration,
– possibility of survival outside human host,
– presence of vectors or means of dissemination,
– biological stability,
– antibiotic resistance patterns,
– allergenicity,
– availability of appropriate therapies.

v. other product hazards.

III. Information relating to the conditions of release and the receiving environment

A. Information on the release

1. Description of the proposed deliberate release, including the purpose(s) and foreseen products.
2. Foreseen dates of the release and time planning of the experiment including frequency and duration of releases.
3. Preparation of the site previous to the release.
4. Size of the site.
5. Method(s) to be used for the release.
6. Quantities of genetically modified organisms to be released.
7. Disturbance on the site (type and method of cultivation, mining, irrigation, or other activities).
8. Worker protection measures taken during the release.
9. Post-release treatment of the site.
10. Techniques foreseen for elimination or inactivation of the genetically modified organisms at the end of the experiment.
11. Information on, and results of, previous releases of the genetically modified organisms, especially at different scales and in different ecosystems.

B. Information on the environment (both on the site and in the wider environment)

1. Geographical location and grid reference of the site(s) (in the case of applications for deliberate release in the form of placing on the market pursuant to section 9, second paragraph, litra f, and section 10 of the Gene Technology Act, the site(s) of release will be the foreseen areas of use of the product).
2. Physical or biological proximity to humans and other significant biota.
3. Proximity to significant biotopes, protected areas, or drinking water supplies.
4. Climatic characteristics of the region(s) likely to be affected.
5. Geographical, geological and pedological characteristics.
6. Flora and fauna, including crops, livestock and migratory species.
7. Description of target and non-target ecosystems likely to be affected.
8. A comparison of the natural habitat of the recipient organism with the proposed site(s) of release.
9. Any known planned developments or changes in land use in the region which could influence the environmental impact of the release.

IV. Information relating to the interactions between the genetically modified organisms and the environment

A. Characteristics affecting survival, multiplication and dissemination

1. Biological features which affect survival, multiplication and dispersal.
2. Known or predicted environmental conditions which may affect survival, multiplication and dissemination (wind, water, soil, temperature, pH, etc.).
3. Sensitivity to specific agents.

B. Interactions with the environment

1. Predicted habitat of the genetically modified organisms.
2. Studies of the behaviour and characteristics of the genetically modified organisms and their ecological impact carried out in simulated natural environments, such as microcosms, growth rooms, greenhouses.
3. Genetic transfer capability
   a. postrelease transfer of genetic material from genetically modified organisms into organisms in affected ecosystems;
   b. postrelease transfer of genetic material from indigenous organisms to the genetically modified organisms.
4. Likelihood of postrelease selection leading to the expression of unexpected and/or undesirable traits in the modified organism.
5. Measures employed to ensure and to verify genetic stability. Description of genetic traits which may prevent or minimise dispersal of genetic material. Methods to verify genetic stability.
6. Routes of biological dispersal, known or potential modes of interaction with the disseminating agent, including inhalation, ingestion, surface contact, burrowing, etc..
7. Description of ecosystems to which the genetically modified organisms could be disseminated.
8. Potential for excessive population increase in the environment.
9. Competitive advantage of the genetically modified organisms in relation to the unmodified recipient or parental organism(s).
10. Identification and description of the target organisms if applicable.
11. Anticipated mechanism and result of interaction between the released genetically modified organisms and the target organism(s) if applicable.
12. Identification and description of non-target organisms which may be adversely affected by the release of the genetically modified organism, and the anticipated mechanisms of any identified adverse interaction.
13. Likelihood of postrelease shifts in biological interactions or in host range.
14. Known or predicted interactions with non-target organisms in the environment, including competitors, prey, hosts, symbionts, predators, parasites and pathogens.
15. Known or predicted involvement in biogeochemical processes.
16. Other potential interactions with the environment.

V. Information on monitoring, control, waste treatment and emergency response plans

A. Monitoring techniques

1. Methods for tracing the genetically modified organisms, and for monitoring their effects.
2. Specificity (to identify the genetically modified organisms, and to distinguish them from the donor, recipient or, where appropriate, the parental organisms), sensitivity and reliability of the monitoring techniques.
3. Techniques for detecting transfer of the donated genetic material to other organisms.
4. Duration and frequency of the monitoring.

B. Control of the release

1. Methods and procedures to avoid and/or minimise the spread of the genetically modified organisms beyond the site of release or the designated area for use.
2. Methods and procedures to protect the site from intrusion by unauthorised individuals.
3. Methods and procedures to prevent other organisms from entering the site.

C. Waste treatment

1. Type of waste generated.
2. Expected amount of waste.
3. Description of treatment envisaged.

D. Emergency response plans

1. Methods and procedures for controlling the genetically modified organisms in case of unexpected spread.
2. Methods for decontamination of the areas affected, for example eradication of the genetically modified organisms.
3. Methods for disposal or sanitation of plants, animals, soils, etc., that were exposed during or after the spread.
4. Methods for the isolation of the area affected by the spread.
5. Plans for protecting human health and the environment in case of the occurrence of an undesirable effect.

Part B Information required in applications concerning releases of genetically modified higher plants (gmhps) (gymniospermae and angiospermae)

I. General information

1. Name and address of the applicant (company or institute).
2. Name, qualifications and experience of the responsible scientist(s).
3. Title of the project,

II. Information relating to the recipient or (where appropriate) parental plants

1. Complete name:
   a) family name;
   b) genus;
   c) species;
   d) subspecies;
   e) cultivar/breeding line;
   f) common name.
2. a) Information concerning reproduction:
   i) mode(s) of reproduction;
   ii) specific factors affecting reproduction, if an;
   iii) generation time.
   b) Sexual compatibility with other cultivated or wild plant species, including the distribution in Europe of the compatible species.
3. Survivability:
   a) ability to form structures for survival or dormancy;
   b) specific factors affecting survivability, if any.
4. Dissemination:
   a) ways and extent of dissemination;
   b) specific factors affecting dissemination, if any.
5. Geographical distribution of the plant.
6. In the case of plant species not normally grown in the EEA Member States, a description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.
7. Other potential interactions, relevant to the genetically modified organism, of the plant with organisms in the ecosystem where it is usually grown, or elsewhere, including information on toxic effects on humans, animals and other organisms.

III. Information relating to the genetic modification

1. 1. Description of the methods used for the genetic modification.
2. Nature and source of the vector used.
3. Size, source (name) of donor organism(s) and intended function of each constituent fragment of the region intended for insertion.

IV. Information relating to the genetically modified higher plant

1. Description of the trait(s) and characteristics which have been introduced or modified.
2. Information on the sequences actually inserted/deleted:
   a) size and structure of the insert and methods used for its characterisation, including information on any parts of the vector introduced in the GMHP or any carrier or foreign DNA remaining in the GMHP;
   b) in case of deletion, size and function of the deleted region(s);
   c) copy number of the insert;
   d) location(s) of the insert(s) in the plant cells (integrated in the chromosome, chloroplasts, mitochondria, or maintained in a nonintegrated form), and methods for its determination.
3. Information on the expression of the insert:
   a) information on the developmental expression of the insert during the lifecycle of the plant and methods used for its characterisation;
   b) parts of the plant where the insert is expressed (for example roots, stem, pollen).
4. Information on how the genetically modified plant differs from the recipient plant in:
   a) mode(s) and/or rate of reproduction;
   b) dissemination;
   c) survivability.
5. Genetic stability of the insert and phenotypic stability of the GMHP.
6. Any change to the ability of the GMHP to transfer genetic material to other organisms.
7. Information on any toxic, allergenic or other harmful effects on human health arising from the genetic modification.
8. Information on the safety of the GMHP to animal health, particularly regarding any toxic, allergenic or other harmful effects arising from the genetic modification, where the GMHP is intended to be used in animal feedstuffs.
9. Mechanism of interaction between the genetically modified plant and target organisms (if applicable).
10. Potential changes in the interactions of the GMHP with non-target organisms resulting from the genetic modification.
11. Potential interactions with the abiotic environment.
12. Description of detection and identification techniques for the genetically modified plant.
13. Information about previous releases of the genetically modified plant, if applicable.

V. Information relating to the site of release (only for applications for release pursuant to section 9, second paragraph, litra a-e, and section 10 of the gene technology act)

1. Location and size of the release site(s).
2. Description of the release site ecosystem, including climate, flora and fauna.
3. Presence of sexually compatible wild relatives or cultivated plant species.
4. Proximity to officially recognised biotopes or protected areas which may be affected.

VI. Information relating to the release (only for applications for release pursuant to section 9, second paragraph, litra a-e, and section 10 of the gene technology act)

1. Purpose of the release.
2. Foreseen date(s) and duration of the release.
3. Method by which the genetically modified plants will be released.
4. Method for preparing and managing the release site, prior to, during and postrelease, including cultivation practices and harvesting methods.
5. Approximate number of plants (or plants per m2).

VII. Information on control, monitoring, postrelease and waste treatment plans (only for applications for release pursuant to section 9, second paragraph, litra a-e, and section 10 of the gene technology act)

1. Any precautions taken:
   a. distance(s) from sexually compatible plant species, both wild relatives and crops;
   b. any measures to minimise/prevent dispersal of any reproductive organ of the GMHP (for example pollen, seeds, tuber).
2. Description of methods for postrelease treatment of the site.
3. Description of postrelease treatment methods for the genetically modified plant material including wastes.
4. Description of monitoring plans and techniques.
5. Description of any emergency plans.
6. Methods and procedures to protect the site.

Part C Additional information

I. In addition to the information set out in parts a and b, the following information shall be provided in an impact assessment for the release of products that consist of or contain genetically-modified organisms pursuant to section 9, second paragraph, litra f, of the gene technology act

1. Proposed commercial names of the products and names of genetically modified organisms contained therein, and any specific identification, name or code used by the notifier to identify the genetically modified organism. After approval any new commercial names should be provided to the competent authority.
2. Name and full address of the person established in the EEA who is responsible for the placing on the market, whether it be the manufacturer, the importer or the distributor,
3. Name and full address of the supplier(s) of control samples.
4. Description of how the product and the genetically modified organism as or in the product are intended to be used. Differences in use or management of the genetically modified organism compared to similar non-genetically modified products should be highlighted.
5. Description of the geographical area(s) and types of environment where the product is intended to be used within the EEA, including, where possible, estimated scale of use in each area.
6. Intended categories of users of the product e.g. industry, agriculture and skilled trades, consumer use by public at large.
7. Information on the genetic modification for the purposes of placing on one or several registers modifications in organisms, which can be used for the detection and identification of particular genetically modified organism products to facilitate post-marketing control and inspection.
8. Proposed labelling on a label or in an accompanying document. This must include, at least in summarised form, a commercial name of the product, the sentence “Dette produktet inneholder genmodifiserte organismer”/“This product contains genetically modified organisms”, the name of the genetically modified organism and the information referred to in point 2; the labelling should indicate how to access the information in the publicly accessible part of the register.

II. In addition to the information in point a, the following information shall if necessary be provided in the impact assessment

1. Measures to take in case of unintended release or misuse.
2. Specific instructions or recommendations for storage and handling.
3. Specific instructions for carrying out monitoring and reporting to the applicant and, if required, the competent authority, so that the competent authorities can be effectively informed of any adverse effect. These instructions should be consistent with Appendix 3, Part C.
4. Proposed restrictions in the approved use of the genetically modified organism, for example where the product may be used and for what purposes.
5. Proposed packaging.
6. Estimated production in and/or imports to the Community.
7. Proposed additional labelling. This may include, at least in summarised form, the information referred to in item I, 4 and 5, and item II, 1, 2, 3 and 4.

Appendix 2 Principles for environmental risk assessment pursuant to sections 13-16 of the regulations

Definitions:

In this appendix, the following terms have the following meanings:

• Direct effects: primary effects on human health or the environment which are a result of the genetically modified organism itself and which do not occur through a causal chain of events;
• Indirect effects: effects on human health 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;
• Immediate effects: effects on human health or the environment which are observed during the period of the release of the genetically modified organism. Immediate effects may be direct or indirect;
• Delayed effects: effects on human health or the environment which may not be observed during the period of the release of the genetically modified organism, but become apparent as a direct or indirect effect either at a later stage or after termination of the release;
• Cumulative effects: the accumulated effects of approvals on human health and the environment, including flora and fauna, soil fertility, soil degradation of organic material, the feed/food chain, biological diversity, animal health and resistance problems in relation to antibiotics.

A. Objective

The objective of an environmental risk assessment is, on a case by case basis, to identify and evaluate potential adverse effects of the genetically modified organism, either direct or indirect, immediate or delayed, on human health and the environment which the deliberate release or the placing on the market of genetically modified organisms may have. The environmental risk assessment is to be based on the principles of cost-benefit analysis. The environmental risk assessment should be conducted with a view to identifying whether there is a need for risk management and if so, the most appropriate methods to be used.

B. General principles

In accordance with the precautionary principle, the following general principles shall be followed when performing the environmental risk assessment:

• Identified characteristics of the genetically modified organism 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.
• The environmental risk assessment should be carried out in a scientifically sound and transparent manner based on available scientific and technical data.
• The environmental risk assessment should be carried out on a case-by-case basis, meaning that the required information may vary depending on the type of the genetically modified organisms concerned, their intended use and the potential receiving environment, taking into account, inter alia, genetically modified organisms already in the environment.
• If new information on the genetically modified organism and its effects on human health or the environment becomes available, the environmental risk assessment may need to be readdressed in order to:
  - determine whether the risk has changed;
  - determine whether there is a need for amending the risk management accordingly.

C. Methodology

C.1. Characteristics of genetically modified organisms and releases

Depending on the case, the environmental risk assessment has to take into account the relevant technical and scientific details regarding characteristics of:

• the recipient or parental organism(s);
• the genetic modification(s), be it inclusion or deletion of genetic material, and relevant information on the vector and the donor;
• the genetically modified organism;
• the intended release or use including its scale;
• the potential receiving environment; and
• the interaction between these.

Information from releases of similar organisms and organisms with similar traits and their interaction with similar environments can be of assistance in carrying out the environmental risk assessment.

C.2. Steps in the environmental risk assessment

In drawing conclusions for the environmental risk assessment, the following points should be addressed:

1. Identification of characteristics which may cause adverse effects:

Any characteristics of the genetically modified organisms linked to the genetic modification that may result in adverse effects on human health or the environment shall be identified. A comparison of the characteristics of the genetically modified organism(s) with those of the non-modified organism under corresponding conditions of release or use will assist in identifying the particular potential adverse effects arising from the genetic modification. It is important not to discount any potential adverse effect on the basis that it is unlikely to occur.

Potential adverse effects of genetically modified organisms will vary from case to case, and may include:

• disease in humans including allergenic or toxic effects (see for example items II.A. and II.C.2(i) in Appendix 1, Part A, and item II.7 in Appendix 1, Part B);
• disease in animals and plants including toxic, and where appropriate, allergenic effects (see for example items II.A.11. and II.C.2(i) in Appendix 1, Part A, and II.7 and IV.8 in Appendix 1, Part B);
• effects on the dynamics of populations of species in the receiving environment and the genetic diversity of each of these populations (see for example items IV.B.8, 9 and 12 in Appendix 1, Part A);
• altered susceptibility to pathogens facilitating the dissemination of infectious diseases and/or creating new reservoirs or vectors;
• 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 (see for example items II.A.11(e) and II.C.2 i and iv in Appendix 1, Part A);
• effects on biogeochemistry (biogeochemical cycles), particularly carbon and nitrogen recycling through changes in soil decomposition of organic material (see for example items II.A.11(f) and IV.B.15 in Appendix 1, Part A, and item IV.11 in Appendix 1,Part B).

Adverse effects may occur directly or indirectly through mechanisms which may include:

• the spread of the genetically modified organism(s) in the environment;
• the transfer of the inserted genetic material to other organisms, or the same organism whether genetically modified or not;
• phenotypic and genetic instability;
• interactions with other organisms;
• changes in management, including, where applicable, in agricultural practices.

2. Evaluation of the potential consequences of each adverse effect, if it occurs

The magnitude of the consequences of each potential adverse effect should be evaluated.

This evaluation should assume that such an adverse effect will occur. The magnitude of the consequences is likely to be influenced by the environment into which the genetically modified organism(s) is (are) intended to be released and the manner of the release.

3. Evaluation of the likelihood of the occurrence of each identified potential adverse effect

A major factor in evaluating the likelihood or probability of adverse effects occurring is the characteristics of the environment into which the genetically modified organism(s) is (are) intended to be released, and the manner of the release.

4. Estimation of the risk posed by each identified characteristic of the genetically modified organism(s)

An estimation of the risk to human health or the environment posed by each identified characteristic of the genetically modified organism which has the potential to cause adverse effects should be made as far as possible, given the state of the art, by combining the likelihood of the adverse effect occurring and the magnitude of the consequences, if it occurs.

5. Application of management strategies for risks from the deliberate release or marketing of genetically modified organism(s)

The risk assessment may identify risks that require management and how best to manage them, and a risk management strategy should be defined.

6. Determination of the overall risk of the genetically modified organism(s)

An evaluation of the overall risk of the genetically modified organism(s) should be made taking into account any risk management strategies which are proposed.

D. Conclusions on the potential environmental impact from the release or the placing on the market of genetically modified organisms

On the basis of an environmental risk assessment carried out in accordance with the principles and methodology outlined in sections B and C, information on the points listed in sections D1 or D2 should be included, as appropriate, in applications with a view to assisting in drawing conclusions on the potential environmental impact from the release or the placing on the market of genetically modified organisms:

D.1. In the case of genetically modified organisms other than higher plants

1. Likelihood of the genetically modified organism becoming persistent and invasive in natural habitats under the conditions of the proposed release(s).
2. Any selective advantage or disadvantage conferred on the genetically modified organism and the likelihood of this being realised under the conditions of the proposed release(s).
3. Potential for gene transfer to other species under conditions of the proposed release of the genetically modified organism and any selective advantage or disadvantage conferred on those species.
4. Potential immediate and/or delayed environmental impact of the direct and indirect interactions between the genetically modified organism and target organisms (if applicable).
5. Potential immediate and/or delayed environmental impact of the direct and indirect interactions between the genetically modified organism and non-target organisms, including impact on population levels of competitors, prey, hosts, symbionts, predators, parasites and pathogens.
6. Possible immediate and/or delayed effects on human health resulting from potential direct and indirect interactions of the genetically modified organism and persons working with, coming into contact with or in the vicinity of the genetically modified organism release(s).
7. Possible immediate and/or delayed effects on animal health and consequences for the feed/food chain resulting from consumption of the genetically modified organism and any product derived from it, if it is intended to be used as animal feed.
8. Possible immediate and/or delayed effects on biogeochemical processes resulting from potential direct and indirect interactions of the genetically modified organism and target and non-target organisms in the vicinity of the genetically modified organism release(s).
9. Possible immediate and/or delayed, direct and indirect environmental impacts of the specific techniques used for the management of the genetically modified organism where these are different from those used for non-genetically modified organisms.

D.2. In the case of genetically modified higher plants (GMHPs)

1. Likelihood of the GMHP becoming more persistent than the recipient or parental plants in agricultural habitats or more invasive in natural habitats.
2. Any selective advantage or disadvantage conferred on the GMHP.
3. Potential for gene transfer to the same or other sexually compatible plant species in connection with the planting of the GMHP and any selective advantage or disadvantage conferred on those plant species
4. Potential immediate and/or delayed environmental impact resulting from direct and indirect interactions between the GMHP and target organisms, such as predators, parasitoids, and pathogens (if applicable).
5. Possible immediate and/or delayed environmental impact resulting from direct and indirect interactions of the GMHP with non-target organisms (also taking into account organisms which interact with target organisms), including impact on population levels of competitors, herbivores, symbionts (where applicable), parasites and pathogens.
6. Possible immediate and/or delayed effects on human health resulting from potential direct and indirect interactions of the GMHP and persons working with, coming into contact with or in the vicinity of the GMHP release(s).
7. Possible immediate and/or delayed effects on animal health and consequences for the feed/food chain resulting from consumption of the genetically modified organism and any products derived from it, if it is intended to be used as animal feed.
8. Possible immediate and/or delayed effects on biogeochemical processes resulting from potential direct and indirect interactions of the genetically modified organism and target and non-target organisms in the vicinity of the genetically modified organism release(s).
9. Possible immediate and/or delayed, direct and indirect environmental impacts of the specific cultivation, management and harvesting techniques used for the GMHP where these are different from those used for non-GMHPs.

Appendix 3 Monitoring plan

I. Objective

The objective of a monitoring plan is to:

• confirm that any assumption regarding the occurrence and impact of potential adverse effects of the genetically modified organism or its use made in the environmental risk assessment are correct, and
• identify the occurrence of adverse effects of the genetically modified organism or its use on human health or the environment which were not anticipated in the environmental risk assessment

II. General principles

Monitoring takes place after approval has been given for the placing of a genetically modified organism on the market.

The interpretation of the data collected by monitoring should be considered in the light of other existing environmental conditions and activities. Where changes in the environment are observed, further assessment should be considered to establish whether they are a consequence of the genetically modified organism or its use, as such changes may be the result of environmental factors other than the placing of the genetically modified organism on the market.

Experience and data gained through the monitoring of experimental releases of genetically modified organisms may assist in designing the post-marketing monitoring regime required for the placing on the market of genetically modified organisms as or in products.

III. Design of the monitoring plan

The design of the monitoring plan should:

1. be detailed on a case-by-case basis taking into account the environmental risk assessment;
2. take into account the characteristics of the genetically modified organism, the characteristics and scale of its intended use and the range of relevant environmental conditions where the genetically modified organism is expected to be released;
3. incorporate general surveillance for unanticipated adverse effects and, if necessary, (case-) specific monitoring focusing on adverse effects identified in the environmental risk assessment:
   a) case-specific monitoring shall 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 environmental risk assessment;
   b) surveillance can, if appropriate, make use of already established routine surveillance practices such as the monitoring of agricultural cultivars, plant protection, or veterinary and medical products. An explanation as to how relevant information collected through established routine surveillance practices will be made available to the approval-holder should be provided;
4. facilitate the observation, in a systematic manner, of the release of a genetically modified organism in the receiving environment and the interpretation of these observations with respect to safety to human health or the environment;
5. identify who (applicant, users) 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 approval-holder and the competent authority will be informed of any observed adverse effects on human health and the environment. (Time points and intervals for reports on the results of the monitoring shall be indicated);
6. give consideration to the mechanisms for identifying and confirming any observed adverse effects on human health and environment and enable the approval-holder or the competent authority, where appropriate, to take the measures necessary to protect human health and the environment.

Appendix 4 Evaluation of ethical considerations, sustainability and benefit to society, cf section 17 of the regulations

Introduction

This appendix explains what should be included in an account of other consequences of the production and use of genetically modified organisms pursuant to section 17 of the regulations. To the extent necessary, such an account should as far as possible include all the elements listed in the appendix. However, the appendix is not exhaustive, and not all the elements will be relevant in every case.

The purpose of the Gene Technology Act, as set out in its section 1, is to ensure that the production and use of genetically modified organisms and the production of cloned animals take place in an ethically justifiable and socially acceptable manner, in accordance with the principle of sustainable development and without adverse effects on human and animal health and the environment. Section 10, second paragraph, of the Act lays down that the deliberate release of genetically modified organisms may only be approved when there is no risk of adverse effects on human or animal health or the environment, and that considerable weight is to be given to whether the deliberate release of genetically modified organisms will be of benefit to society and is likely to promote sustainable development. The comments on the objects clause of the Act in Proposition No. 8 (1992 to 1993) to the Odelsting make it clear that the precautionary principle is to be used as a basis in evaluating potential adverse effects on human and animal health and the environment, and that ethical considerations must be given considerable weight when making decisions on applications for approval pursuant to the Act. The comments on section 10, second paragraph, make it clear that when applications for deliberate release pursuant to the Act are considered, any benefits to society and contributions to sustainable development are to be used both as independent criteria for the evaluation of applications and as criteria that may make result in less strict application of the requirement that the release of genetically modified organisms must not have adverse effects on health or the environment. An evaluation of benefits to society and contribution to sustainable development should be based on the principles of cost-benefit analysis.

I. Procedure for the evaluation

The evaluation should be organised as follows:

1. Risk of adverse effects on human and animal health and the environment:
   a) what are the possible adverse effects?
   b) how probable are these effects?
2. Precautionary principle:
   a) is there justified uncertainty associated with the risk assessment?
   b) is there a possibility of substantial or irreversible harm?
3. Will the project
   a) tend to promote or hinder sustainable development?
   b) have favourable or unfavourable social consequences?
   c) be ethically justifiable?

In assessing the questions in item 3, it can be useful to distinguish between the following three elements:

• the characteristics of the product
• its production
• its use

II. Risk of adverse effects on human and animal health and the environment

A. Checklist

• Does the application provide sufficient documentation for evaluating possible adverse effects?
• Is it reasonable to assume that there will be a major or significant risk to health or the environment?
• Is it reasonable to assume that there will be major or significant adverse effects on health or the environment?
• Is it reasonable to assume that there will be major or significant adverse cumulative effects on health or the environment?

B. Comments

If the answer to question 1 is no, the application shall be evaluated in relation to question 2 in part I above on the precautionary principle.

If the answer to one or more of questions 2-4 is yes, the application shall be refused. If the answer to all of questions 2-4 is no, the application shall be evaluated in relation to the precautionary principle.

III. The precautionary principle

A. Checklist

• Is there a reasonable degree of doubt about existing risk assessments, and is there a danger that the risk may be higher than these assessments indicate?
• Is there a reasonable degree of doubt about existing probability assessments, and is there a danger that the probability of adverse effects is higher than these assessments indicate?
• Is there a reasonable degree of doubt about existing impact assessments and is there a danger of even more serious effects on health and the environment than these assessments indicate?
• Is there a reasonable degree of doubt about possible serious cumulative effects on health or the environment?
• Is there a reasonable degree of doubt as to whether proposed mitigating measures and instruments will function as intended?

B. Comment

If the answer to one or more of these questions is yes, this indicates that the application can be refused with reference to the precautionary principle.

IV. Sustainable development

A. Checklist

1. Global impacts
   • Will there be global impacts on biodiversity?
   • Will there be impacts on ecosystem functioning?
   • Will there be differences between the impacts of production and use in these respects?
2. Ecological limits
   • Will there be any impact on the efficiency of energy use?
   • Will there be any impact on the efficiency of other natural resource use?
   • Will there be any impact on the proportions of renewable and non-renewable resources used?
   • Will there be any impact on emissions of global and transboundary pollutants?
   • Will there be any particular impact on greenhouse gas emissions)
   • Will there be differences between the impacts of production and use in these respects?
3. Basic human needs
   • Will there be any impact on the degree to which basic human needs are met?
   • Will there be differences between the impacts of production and use in these respects?
4. Distribution between generations
   • Will there be any impact on the distribution of benefits between generations?
   • Will there be any impact on the distribution of burdens between generations?
   • Will there be differences between the impacts of production and use in these respects?
5. Distribution between rich and poor countries
   • Will there be any impact on the distribution of benefits between rich and poor countries?
   • Will there be any impact on the distribution of burdens between rich and poor countries?
   • Will there be differences between the impacts of production and use in these respects?
6. Economic growth
   • Will there be any impact on the use of energy and other natural resources for economic growth?
   • Will there be any impact on the global/transnational environmental impacts of economic growth?
   • Will the there be any impact on the distribution of economic growth between rich and poor countries?
   • Will there be differences between the impacts of production and use in these respects?

B. Comment

An evaluation of whether a project is in accordance with the principle of sustainable development must be based on an overall assessment and discussion of all these questions. However, not all the questions will be relevant in all cases.

V. Favourable or unfavourable social consequences

A. Checklist

1. Characteristics of the product
   • Is it reasonable to say that there is a demand or a need for the product?
   • Is it reasonable to say that the product will solve or help to solve a social problem?
   • Is it reasonable to say that the product is significantly better than similar products that are already on the market?
   • Is it reasonable to say that there are alternatives that are more suitable than this product for solving or helping to solve the social problem in question?
2. Production and use of the product
   • Will the product have a positive effect on industrial development and wealth creation, including new employment opportunities?
   • Will the product have a positive effect on industrial development and wealth creation, including new employment opportunities, in rural areas in particular?
   • Will the product have a positive effect on industrial development and wealth creation, including new employment opportunities, in other countries?
   • Will the product tend to create problems for existing production that should be maintained?
   • Will the product tend to create problems for existing production in other countries?

B. Comment

An evaluation of whether a product is of benefit to society must be based on a discussion of the answers to all these questions. However, not all the questions will be relevant in all cases.

VI. Ethical considerations

A. General considerations

1. Analysis of the situation
   • What alternatives are there?
   • Which parties are involved? How will they be disadvantaged by or benefit from the different alternatives?
2. Ethical reasoning
   • Which norms are applicable?
   • How can any conflict between these norms be resolved?
3. Implementation
   • How can the best alternative be implemented in practice?

B. Checklist

1. Ethical norms and values relating to people
   • Will approval or prohibition of the product and its production and use be in accordance with the moral views of the general population?
   • Will the product or its production and use come into conflict with the ideals of solidarity and equality between people, such as the need to show special consideration for weaker groups?
   • Decisions made by mainstream society can have a serious adverse impact on indigenous peoples, people who live in highly traditional cultures, and weaker groups. Special account should be taken of the need of these groups to be able to control their own processes of social change.
   • Will the marketing and sales, in particular, of the product come into conflict with ethical norms and values relating to people?
2. Eco-ethical considerations
   • Will the product and its production be in conflict with any intrinsic value assigned to animal species?
   • Will the production of the product cause unnecessary suffering to animals?
   • Will the production of the product involve crossing species barriers in ways that are materially different from those otherwise found in cultivation or in the wild, and that must be considered incompatible with the value assigned to the integrity of species.

C. Comment

An evaluation of other ethical and social considerations must be based on a discussion of the answers to all these questions. However, not all the questions will be relevant in all cases.