Annexes to COM(2013)758 - Placing on the market for cultivation of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests - Main contents
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| dossier | COM(2013)758 - Placing on the market for cultivation of a maize product (Zea mays L., line 1507) genetically modified for resistance to ... |
|---|---|
| document | COM(2013)758  |
| date | November 6, 2013 |
Monitoring by the consent holder
1. In the context of Article 4(3)(a) on case-specific monitoring, the consent holder shall increase the frequency of monitoring activities as appropriate, taking account of the rate at which potential resistance to the CRY1F protein is likely to evolve the resistance management strategy as well as the scale and the geographical dispersal of Zea mays L., line 1507, and shall revise the sampling protocol to detect resistance alleles frequency between 1% to 3%.
2. The consent holder shall carry out general surveillance of unanticipated potential effects on non-target insects in particular (including parasitoids), taking into account the possibility of both direct and indirect effects on those and other non-target organisms including other arthropods.
3. The consent holder shall also:
(a) assist in insect collections for relevant analyses in the context of general surveillance;
(b) encourage growers to report any observed adverse effects (including on non-target insects or derived from changes in conventional agricultural practices);
(c) participate in monitoring programmes developed by the EU Competent Authorities or other relevant national authorities appropriate to 1507 maize.
4. The farmer questionnaire referred to in Article 4, paragraph 3(b) shall include the following elements in line with EFSA opinions:
(a) a request to the farmer to provide factual information as opposed to only comments as to possible observed differences;
(b) a request to the farmer to provide data on fertilizer usage, soil fertility, crop rotations, crop performance, crop yield, pests and diseases, pesticide use, weed abundance and on regionally occurring lepidopteran pests other than corn borers;
(c) a particular focus on sites where Zea mays L., line 1507 is a significant proportion of the maize being grown and on years following cultivation. The selection of farms shall be done independently of the size of Bt-maize cultivation. In addition, the sampling strategy shall ensure that 2500 farmer questionnaires are collected over the period of cultivation to achieve an acceptable statistical power;
(d) a structure designed to elicit detailed information. The questions should be presented in a way that the respondent can choose from a selection of answers;
(e) an additional field for free answers or comments following the pre-formulated answers to allow comments on other factors not covered specifically in the questionnaire;
(f) the standard procedures of univariate or multivariate and cumulative analysis of the questionnaire’s key variables to be analysed by the consent-holder should be described precisely;
(g) questions regarding the occurrence of beneficial insects and other wildlife.
5. The consent holder shall ensure that the general surveillance network involves all necessary existing surveillance systems and any new surveillance systems required in addition to that established through the farmer questionnaire. The consent holder shall consult networks involved in relevant biodiversity surveys at local, national and Union level.
6. The monitoring plan shall include: observation parameters; survey methods, location and frequency; timetable for inspections; description and details of representativeness of the receiving environment; reference areas; relevant agreements with third parties; adaptation of the plan to regional conditions.
ANNEX II
Content of the leaflet for operators
Throughout the period of validity of the consent, the consent holder, when placing seeds from varieties derived from the Zea mays L., line 1507 on the market in a Member State, shall, based on the conditions for placing on the market set out in Article 3, distribute a leaflet with each bag of seeds of the Zea mays L., line 1507 indicating the following:
(a) General description of the product, including general characteristics of and safety requirements for varieties derived from the Zea mays L., line 1507, and the unique identifier assigned to the GMO;
(b) Mention of the requirement that the transmission of seed from varieties derived from the Zea mays L., line 1507, between operators be recorded by the operators, and that written information regarding the product must be provided as established by Article 4 of Regulation (EC) No 1830/2003;
(c) Design and management of the planting, including guidance to the operators to design refuges;
(d) An indication of the applicable national legislation on the cultivation of GMOs, including legislation on co-existence between GM maize crops and non-GM maize crops where applicable and its detailed provisions as regards treatment of equipment and product material, notification requirements if applicable, and distances or buffer zones where relevant, among others, and reminder of the basic obligations for the cultivation and use of the product at national and Union level;
(e) Monitoring requirements according to the insect resistance management plan, and reference to the farmer questionnaire.
[1] OJ L 106, 17.4.2001, p. 1.
[2] OJ L 111, 23.4.2013, p.27.
[3] The EFSA Journal (2005) 181, 1-33.
[4] The EFSA Journal (2011), 9(11):2429.
[5] The EFSA Journal (2012), 10(11):2934.
[6] The EFSA Journal (2012), 10(10):2933.
[7] OJ L 291, 5.11.2005, p. 42.
[8] OJ L 70, 9.3.2006, p. 82.
[9] OJ L 268, 18.10.2003, p. 24.
[10] OJ L 10, 16.1.2004, p. 5.
[11] OJ L 102, 7.4.2004, p. 14.
[12] Reference Material: ERM®-BF418 accessible via the Joint Research Centre (JRC) of the European Commission, the Institute for Reference Materials and Measurements (IRMM) at http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm
[13] OJ L 275, 21.10.2009, p. 9.