European Parliament resolution of 24 October 2018 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122, and genetically modified maize combining two, three or four of the single events MON 87427, MON 89034, 1507, MON 88017 and 59122 and repealing Decision 2011/366/EU (D058361/01 — 2018/2873(RSP))
Date: 2018-10-24
Institutions: Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: animal feedingstuffs, food safety, foodstuff, labelling, maize, market approval, transgenic plant








C_2020345EN.01001301.xml










16.10.2020   


EN


Official Journal of the European Union


C 345/13






P8_TA(2018)0417
Authorisation for genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122
European Parliament resolution of 24 October 2018 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122, and genetically modified maize combining two, three or four of the single events MON 87427, MON 89034, 1507, MON 88017 and 59122 and repealing Decision 2011/366/EU (D058361/01 — 2018/2873(RSP))
(2020/C 345/03)

The European Parliament,






—


having regard to the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122, and genetically modified maize combining two, three or four of the single events MON 87427, MON 89034, 1507, MON 88017 and 59122 and repealing Decision 2011/366/EU (D058361/01,










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having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Articles 7(3) and 19(3) thereof,










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having regard to the vote of the Standing Committee on the Food Chain and Animal Health referred to in Article 35 of Regulation (EC) No 1829/2003, on 11 September 2018, at which no opinion was delivered,










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having regard to Article 11 of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (2),










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having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 28 June 2017 and published on 1 August 2017 (3),










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having regard to the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 182/2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (COM(2017)0085, COD(2017)0035),










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having regard to its previous resolutions objecting to the authorisation of genetically modified organisms (4),










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having regard to the motion for a resolution of the Committee on the Environment, Public Health and Food Safety,










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having regard to Rule 106(2) and (3) of its Rules of Procedure,










A.


whereas, on 26 November 2013, Monsanto Europe S.A./N.V. submitted, on behalf of Monsanto Company, an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122 (‘the application’) to the national competent authority of Belgium; whereas the application also covered the placing on the market of products containing or consisting of genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122 for uses other than food and feed, with the exception of cultivation;










B.


whereas, in addition, the application covered the placing on the market of products containing, consisting of or produced from 25 sub-combinations of the single transformation events constituting genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122; whereas 12 of these sub-combinations are already authorised; whereas the Commission implementing decision authorising the maize covers 14 sub-combinations;










C.


whereas Monsanto Europe S.A./N.V., the authorisation holder for one of the 12 sub-combinations already authorised, sub-combination MON 89034 × MON 88017, requested that the Commission repeal Decision 2011/366/EU and incorporate this Decision into the scope of the Commission Decision; whereas this request was granted; whereas the legitimacy of such an approach is questionable;










D.


whereas, on 28 June 2017, EFSA adopted a favourable opinion, in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (5), related to the five-event stack maize, the previously assessed sub-combinations and the remaining sub-combinations;










E.


whereas EFSA acknowledges that no specific data have been submitted for any of the 14 sub-combinations; whereas many of them have not even been created yet; whereas EFSA nevertheless concludes that all sub-combinations are ‘expected to be as safe as the five-event stack maize’;










F.


whereas no toxicology testing has been performed, and no animal studies with food/feed derived from genetically modified maize MON 87427, MON 89034, 1507, MON 88017 and 59122, or any of the sub-combinations, were provided (6);










G.


whereas two of the maize varieties involved express proteins which confer tolerance to the glufosinate-ammonium herbicide (7); whereas glufosinate is classified as toxic to reproduction and thus falls under the exclusion criteria set out in Regulation (EC) No 1107/2009; whereas the approval of glufosinate expired on 31 July 2018 (8);










H.


whereas two of the maize varieties involved express proteins which confer tolerance to glyphosate herbicides; whereas, on 20 March 2015, the International Agency for Research on Cancer — the specialised cancer agency of the World Health Organisation — classified glyphosate as probably carcinogenic to humans (9);










I.


whereas authorising the import of genetically modified maize MON 87427, MON 89034, 1507, MON 88017 and 59122 into the Union is supposed to lead to an increase in its cultivation elsewhere, such as in Mexico and South Korea, and to a corresponding increase in the use of glufosinate ammonium or glyphosate containing herbicides;










J.


whereas four of the maize varieties involved express Cry proteins, which are Bt proteins (derived from Bacillus thuringiensis) conferring resistance to certain lepidopteran and coleopteran pests respectively;










K.


whereas genetically modified Bt plants express the insecticidal toxin in every cell throughout their life, including in the parts eaten by humans and animals; whereas animal feeding experiments show that genetically modified Bt plants may have toxic effects (10); whereas it has been shown that the Bt toxin in genetically modified plants differs significantly from that of the naturally occurring Bt toxin (11);










L.


whereas concerns remain regarding a possible evolution of resistances to the Cry proteins in the target pests, which may lead to altered pest control practices in the countries where it is cultivated;










M.


whereas many critical comments were submitted by Member States during the three-month consultation period; whereas those comments refer to, inter alia: poor test designs, missing tests, e.g. as regards nutritional assessment, or the lack of any 90-day feeding study in rodents; missing or insufficient data, e.g. regarding unintended effects associated with the combination of the events, or regarding potential interactions of the eight proteins, which might lead to unintended effects; wrong assumptions by the applicant, e.g. as regards degradation of orally ingested DNA during its passage through the gastrointestinal tract; a partly missing environmental risk assessment, and an insufficient environmental monitoring plan (12);










N.


whereas independent research also raises concerns about major gaps in the comparative assessment, serious gaps as regards the missing toxicology assessment, about the inconclusive assessment with regard to allergenicity, the lack of consideration of combinatorial effects, and a flawed environmental risk assessment (13);










O.


whereas, in spite of all of these concerns, EFSA did not consider any post-market monitoring of food/feed derived from genetically modified maize MON 87427, MON 89034, 1507, MON 88017 and 59122 and its sub-combinations to be necessary;










P.


whereas the vote on 11 September 2018 of the Standing Committee on the Food Chain and Animal Health referred to in Article 35 of Regulation (EC) No 1829/2003 delivered no opinion; whereas 14 Member States voted against, while only 11 voted in favour, and three abstained;










Q.


whereas, both in the explanatory memorandum of its legislative proposal presented on 22 April 2015 amending Regulation (EC) No 1829/2003 as regards the possibility for the Member States to restrict or prohibit the use of genetically modified food and feed on their territory and in the explanatory memorandum of the legislative proposal presented on 14 February 2017 amending Regulation (EU) No 182/2011, the Commission deplored the fact that, since the entry into force of Regulation (EC) No 1829/2003, authorisation decisions have been adopted by the Commission without the support of the Member States’ committee opinion and that the return of the dossier to the Commission for final decision, which is very much the exception for the procedure as a whole, has become the norm for decision-making on genetically modified food and feed authorisations; whereas that practice has, on several occasions, been deplored by Commission President Jean-Claude Juncker as not being democratic (14);










R.


whereas on 28 October 2015 Parliament rejected at first reading (15) the legislative proposal of 22 April 2015 amending Regulation (EC) No 1829/2003 and called on the Commission to withdraw it and submit a new one;












1.


Considers that the draft Commission implementing decision exceeds the implementing powers provided for in Regulation (EC) No 1829/2003;












2.


Considers that the draft Commission implementing decision is not consistent with Union law in that it is not compatible with the aim of Regulation (EC) No 1829/2003, which is, in accordance with the general principles laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council (16), to provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, and environmental and consumer interests in relation to genetically modified food and feed, while ensuring the effective functioning of the internal market;












3.


Considers, more specifically, that the draft Commission implementing decision runs contrary to the principles of the general food law, as laid down in Regulation (EC) No 178/2002, to approve varieties for which no safety data have been provided, which have not even been tested, or which have not even been created yet;












4.


Calls on the Commission to withdraw its draft implementing decision;












5.


Calls on the Commission to suspend any implementing decision regarding applications for authorisation of genetically modified organisms until the authorisation procedure has been revised in such a way so as to address the shortcomings of the current procedure, which has proven inadequate;












6.


Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States.






(1)  OJ L 268, 18.10.2003, p. 1.

(2)  OJ L 55, 28.2.2011, p. 13.

(3)  Scientific opinion on application EFSA-GMO-BE-2013-118 for authorisation of genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122 and subcombinations independently of their origin, for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto Company, EFSA Journal Volume 15, Issue 8: https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2017.4921

(4)  






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Resolution of 16 January 2014 on the proposal for a Council decision concerning the placing on the market for cultivation, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests (OJ C 482, 23.12.2016, p. 110).










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Resolution of 16 December 2015 on Commission Implementing Decision (EU) 2015/2279 of 4 December 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize NK603 × T25 (OJ C 399, 24.11.2017, p. 71).










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Resolution of 3 February 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87705 × MON 89788 (OJ C 35, 31.1.2018, p. 19).










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Resolution of 3 February 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87708 × MON 89788 (OJ C 35, 31.1.2018, p. 17).










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Resolution of 3 February 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 (MST-FGØ72-2) (OJ C 35, 31.1.2018, p. 15).










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Resolution of 8 June 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × MIR162 × MIR604 × GA21, and genetically modified maizes combining two or three of those events (OJ C 86, 6.3.2018, p. 108).










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Resolution of 8 June 2016 on the draft Commission implementing decision as regards the placing on the market of a genetically modified carnation (Dianthus caryophyllus L., line SHD-27531-4) (OJ C 86, 6.3.2018, p. 111).










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Resolution of 6 October 2016 on the draft Commission implementing decision renewing the authorisation for the placing on the market for cultivation of genetically modified maize MON 810 seeds (OJ C 215, 19.6.2018, p. 76).










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Resolution of 6 October 2016 on the draft Commission implementing decision authorising the placing on the market of genetically modified maize MON 810 products (OJ C 215, 19.6.2018, p. 80).










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Resolution of 6 October 2016 on the draft Commission implementing decision concerning the placing on the market for cultivation of genetically modified maize Bt11 seeds (OJ C 215, 19.6.2018, p. 70).










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Resolution of 6 October 2016 on the draft Commission implementing decision concerning the placing on the market for cultivation of genetically modified maize 1507 seeds (OJ C 215, 19.6.2018, p. 73).










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Resolution of 6 October 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton 281-24-236 × 3006-210-23 × MON 88913 (OJ C 215, 19.6.2018, p. 83).










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Resolution of 5 April 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × 59122 × MIR604 × 1507 × GA21, and genetically modified maizes combining two, three or four of the events Bt11, 59122, MIR604, 1507 and GA21 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 298, 23.8.2018, p. 34).










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Resolution of 17 May 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize DAS-40278-9, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 307, 30.8.2018, p. 71).










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Resolution of 17 May 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB119 (BCS-GHØØ5-8) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ C 307, 30.8.2018, p. 67).










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Resolution of 13 September 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean DAS-68416-4, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 337, 20.9.2018, p. 54).










—


Resolution of 4 October 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 × A5547-127 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 346, 27.9.2018, p. 55).










—


Resolution of 4 October 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean DAS-44406-6, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 346, 27.9.2018, p. 60).










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Resolution of 24 October 2017 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507 (DAS-Ø15Ø7-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 346, 27.9.2018, p. 122).










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Resolution of 24 October 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 305423 × 40-3-2 (DP-3Ø5423-1 × MON-Ø4Ø32-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 346, 27.9.2018, p. 127).










—


Resolution of 24 October 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified oilseed rapes MON 88302 × Ms8 × Rf3 (MON-883Ø2-9 × ACSBNØØ5-8 × ACS-BNØØ3-6), MON 88302 × Ms8 (MON-883Ø2-9 × ACSBNØØ5-8) and MON 88302 × Rf3 (MON-883Ø2-9 × ACS-BNØØ3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 346, 27.9.2018, p. 133).










—


Resolution of 1 March 2018 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize 59122 (DAS-59122-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (Texts adopted, P8_TA(2018)0051).










—


Resolution of 1 March 2018 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 × MON 89034 × NK603 (MON-87427-7 × MON-89Ø34-3 × MON-ØØ6Ø3-6) and genetically modified maize combining two of the events MON 87427, MON 89034 and NK603, and repealing Decision 2010/420/EU (Texts adopted, P8_TA(2018)0052).










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Resolution of 3 May 2018 on the draft Commission implementing decision renewing the authorisation for the placing on the market of food and feed produced from genetically modified sugar beet H7-1 (KM-ØØØH71-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (Texts adopted, P8_TA(2018)0197).










—


Resolution of 30 May 2018 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (Texts adopted, P8_TA(2018)0221).










—


Resolution of 30 May 2018 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507 × 59122 × MON 810 × NK603, and genetically modified maize combining two or three of the single events 1507, 59122, MON 810 and NK603, and repealing Decisions 2009/815/EC, 2010/428/EU and 2010/432/EU pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (Texts adopted, P8_TA(2018)0222).





(5)  EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2017. Scientific Opinion on application EFSA-GMO-BE-2013-118 for authorisation of genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122 and subcombinations independently of their origin, for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto Company. EFSA Journal 2017; 15(8):4921, pp. 32: https://doi.org/10.2903/j.efsa.2017.4921

(6)  As confirmed in the EFSA opinion referred to above (EFSA Journal 2017; 15(8):4921).

(7)  MON-87427-7 maize expresses the CP4 EPSPS protein, which confers tolerance to glyphosate-based herbicides; MON-89Ø34-3 maize expresses the Cry1A.105 and Cry2Ab2 proteins, which confer protection against certain lepidopteran pests; DAS-Ø15Ø7-1 maize expresses the Cry1F protein, which confers protection against certain lepidopteran pests, and the PAT protein, which confers tolerance to glufosinate-ammonium-based herbicides; MON-88Ø17-3 maize expresses a modified Cry3Bb1 protein, which provides protection to certain coleopteran pests, and the CP4 EPSPS protein, which confers tolerance to glyphosate-based herbicides; DAS-59122-7 maize expresses Cry34Ab1 and Cry35Ab1 proteins, which confer protection against certain coleopteran pests, and the PAT protein, which confers tolerance to glufosinate-ammonium-based herbicides.

(8)  http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.detail&language=EN&selectedID=1436

(9)  IARC Monographs Volume 112: evaluation of five organophosphate insecticides and herbicides, 20 March 2015: http://monographs.iarc.fr/ENG/Monographs/vol112/mono112.pdf

(10)  See, for example, El-Shamei Z.S., Gab-Alla A.A., Shatta A.A., Moussa E.A., Rayan A.M., Histopathological Changes in Some Organs of Male Rats Fed on Genetically Modified Corn (Ajeeb YG), Journal of American Science, 2012; 8(9), pp. 1117-1123: https://www.researchgate.net/publication/235256452_Histopathological_Changes_in_Some_Organs_of_Male_Rats_Fed_on_Genetically_Modified_Corn_Ajeeb_YG

(11)  Székács A., Darvas B.., Comparative aspects of Cry Toxin Usage in Insect Control, in: Ishaaya I., Palli S.R., Horowitz A.R. (eds.), Advanced Technologies for Managing Insect Pests, Dordrecht, Netherlands, Springer, 2012; pp. 195-230: https://link.springer.com/chapter/10.1007/978-94-007-4497-4_10

(12)  See EFSA Register of Questions, Annex G to Question Number EFSA-Q-2013-00926 available online at: http://registerofquestions.efsa.europa.eu/roqFrontend/ListOfQuestionsNoLogin?1

(13)  Bauer-Panskus, A, Then, C, Testbiotech comment on ‘Scientific Opinion on application EFSA-GMO-BE-2013-118 for authorisation of genetically modified maize MON 87427 x MON 89034 x 1507 x MON 88017 x 59122 and subcombinations independently of their origin, for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto Company’, available at: https://www.testbiotech.org/sites/default/files/Testbiotech_Comment_Maize%20MON%2087427%20x%20MON%2089034%20x%201507%20x%20MON%2088017%20x%2059122.pdf

(14)  For example in the Opening Statement at the European Parliament plenary session included in the Political Guidelines for the next European Commission (Strasbourg, 15 July 2014) or in the State of the Union Address 2016 (Strasbourg, 14 September 2016).

(15)  OJ C 355, 20.10.2017, p. 165.

(16)  OJ L 31, 1.2.2002, p. 1.