Appendix 2 EXPLANATORY NOTES

Case-specific monitoring will be carried out in accordance with the conditions set out in the consent/authorisation and in accordance with the monitoring plan specified in the notification.

General surveillance for unanticipated or unforeseen adverse effects should also be considered as a compulsory part of the monitoring plan.

Adverse effects should be considered in the light of the crop, the new trait, the receiving environment as well as the conclusions of the environmental risk assessment which is carried out on a case-by-case basis. The following constitutes a non-exhaustive list of effects and consequences or outcomes that could result in adverse environmental effects:

1. (a)

   persistence and invasiveness, selective advantage or disadvantage, including:

   • increased occurrence of volunteers,

   • increased establishment of the genetically modified (GM) plant outside of the fields,

   • increased spread, persistence and accumulation of the GM plant in the environment (including out-crossing with wild relatives);

2. (b)

   altered gene transfer:

   • potential reduction of pollination,

   • increased frequency of horizontal gene transfer from plant to microbial populations;

3. (c)

   interaction between GMP and non-target organisms:

   • direct/indirect impact on non-target organisms,

   • changes of susceptibility to non-target pests and diseases,

   • impact on habitat diversity and biodiversity;

4. (d)

   changes in biogeochemical processes;

5. (e)

   impact on human and animal health resulting from environmental exposure.

F1...

...

The reported data must be illustrated as much as possible by means of diagrams, figures and tables. Statistical data should also be provided where relevant.

The space provided after each item is not indicative of the depth of the information required for the purposes of the report. Relevant supporting documentation should be provided in the form of attachments, which should be clearly cross-referenced to the relevant sections of the report.

Where the information required by the particular consent or authorisation or monitoring plan, as appropriate, cannot be reported a detailed justification should be given.

Confidential parts of the report should be submitted in separate documents.

As far as possible, the report should not contain confidential data. F4...F5Where confidential data does arise, it should be provided in a separate Annex, with a verifiable justification for confidentiality, and a non-confidential summary or general description of these data should be provided in the Annex to the report which will be made available to the public.

Where a crop is cultivated and processed or used for food/feed purposes, F6... a monitoring report for Cultivation must also be completed.

F7...

A summary of the monitoring results obtained and the overall conclusions drawn should be provided. Any proposed adaptation of the monitoring plan and associated methodology on the basis of these results and conclusions should be described.

Commodity Crop (GM + non-GM) imports into Great Britain by country of origin

Details of the following should be provided in F10Table 3.1.1. Actual data should be provided as opposed to estimated data (with the exception of GMO share in imports into Great Britain):

1. (a)

   exporting country where GM crop is cultivated;

2. (b)

   F11...

3. (c)

   ...

4. (d)

   quantity in tons of commodity crop (GM + non-GM) imported F12into Great Britain.

Such analysis should outline the source of the data provided, whether the imports have increased or decreased on previous F14years, the reasons for any F15change and the largest suppliers of extra-Community crops to Great BritainF16....

A description of the general surveillance carried out, including but not limited to details of all methodologies used including parameters observed, data collection methodologies, types of location.

Details of industry, environmental, food and/or feed-related surveillance networks used during the course of the general surveillance carried out should be provided. The following information in relation to each surveillance network identified should be provided:

1. (a)

   name, identifying whether it is an industry, environment, food and/or feed related network;

2. (b)

   F17whether the surveillance network is active, and whether it is active at local, regional or national level;

3. (c)

   website address;

4. (d)

   protection goal;

5. (e)

   how the network collects information relevant to general surveillance;

6. (f)

   procedure for notifying adverse effects to the authorisation/consent holder;

7. (g)

   criteria used to select the surveillance network.

Details of the information made available to importers, traders, handlers, processors etc., when and how this information was made available and the provisions for keeping the aforementioned user groups abreast of any changes to existing information or new information should be provided.

Results of the general surveillance carried out including direct, indirect, delayed and/or cumulative effects observed, and in particular the nature of any adverse effects observed and conclusions drawn should be provided. The observed parameters for all monitoring methodologies should be analysed, interpreted and discussed in detail, while simultaneously demonstrating how these results support the overall conclusions arrived at by the authorisation/consent holder. This section of the report should be as detailed as possible to allow proper interpretation of the data.

Where adverse or unanticipated effects were observed, additional information should be provided, such as the relevant region or location, steps taken to confirm the adverse effect, remedial action or risk-reducing measures that have been or will need to be implemented in view of the adverse effect, consequent implications for the environmental risk assessment and any other conclusions drawn. This section of the report should be as detailed as possible to allow proper interpretation of the data.

Peer-reviewed publications including peer-reviewed journal articles, conference proceedings, review papers and any additional studies or other sources of information relevant to the importation and processing and to food and/or feed use of the crop/trait combination for which the report is being drafted, should be considered and analysed in the context of the monitoring results and the monitoring plan. These publications should be listed, summarised and details provided as per the Appendix. The literature review should identify all relevant publications which have emerged during the reporting period. Conference proceedings, review papers and additional studies carried out by the consent holder which have not been subject to peer review may be provided where they are deemed to be relevant.

Case-specific monitoring requirements identified in the environmental risk assessment (ERA) and the corresponding decision, and the results of the case-specific monitoring carried out should be outlined including detailed information on the methodology, frequency, duration, monitoring results, analysis and conclusions. Under this section the authorisation/consent holder should demonstrate how the information was gathered and analysed in order to support the conclusions arrived at. This section of the report should be as detailed as possible to allow proper interpretation of the data.

The information set out in this section should only be provided where the authorisation or the monitoring plan requires the monitoring of accidental spillage and:

1. (a)

   where processing takes place at sites other than within the confines of the port of importation; or

2. (b)

   in respect of processing locations for GM crops cultivated within the F18United Kingdom.

An overview of the measures taken to monitor accidental spillage should be provided where the authorisation/consent or the current monitoring plan requires such monitoring, e.g. the frequency with which monitoring is carried out, monitoring methodologies used, measures employed to minimise spillage and the clean-up procedures in place. In addition, any unusual, adverse or GMO-related effects observed should be noted. This information should be provided in respect of the following:

1. (a)

   ports through which the GM crops are being imported and where processing takes place within the port boundaries;

2. (b)

   those processing sites identified under Section 3.3.2.

Documentation received from surveillance networks or other surveillance methods in support of any aspect of the monitoring carried out should be annexed to the report and where relevant cross-referenced within the report. A summary of the monitoring results obtained via networks, the literature review and the overall conclusions drawn should be provided.

A summary of the monitoring results obtained and the overall conclusions drawn should be provided. The summary should clearly demonstrate how the findings of the monitoring carried out and the interpretation of data support those conclusions.

An assessment of the monitoring plan and associated methodology used for the purposes of the report should be provided. The effectiveness and limitations of the methodologies used to detect adverse effects should be considered and it should be specified whether the monitoring plan and the associated methodology may need to be modified or adapted in light of the monitoring information with respect to relevance and quality of the data collected and uncertainty of the results presented in the report.