Insufficient risk assessment of herbicide-tolerant genetically engineered soybeans intended for import into the EU

Abstract

The introduction of herbicide-tolerant (HT) genetically engineered (GE) soybeans has raised new challenges for the European risk assessment of imported food and feed. Food and feed products derived from these plants may show specific patterns of chemical residues and altered nutritional composition. Furthermore, there has been a substantial increase in the usage of herbicides in soybean production due to the emergence of resistant weeds. This concerns particular glyphosate-based herbicides and also other herbicides. In this review, we give an overview of available data regarding glyphosate application on HT GE soybeans in North and South America. We have further compared this data with herbicide applications in experimental field trials conducted by the industry. We conclude that field trials carried out for risk assessment purposes do not generally represent the real agronomic conditions in commercial HT GE plant cultivation. In most cases, neither the applied dose nor the number of applications match real conditions. This finding is especially relevant for risk assessment since a review of relevant publications shows that the amount and timing of spraying glyphosate as a complementary herbicide onto HT GE plants can impact their composition; this is relevant to EFSA comparative risk assessment of GMOs. Further, closely related issues were identified that overlap with EU GMO and pesticide regulation, but are not currently considered. These issues concern indirect, cumulative and combinatorial effects as well as the assessment of mixed toxicity. Consequently, current risk assessment practice for HT GE plants cannot be considered to fulfil EU regulatory standards which require the safety of food and feed to be demonstrated. It is much more likely that concerns about the health risks of HT GE plant material used for food and feed have been underestimated. We therefore conclude that the EU risk assessment of food and feed derived from HT GE plants needs substantial improvement.

The Introduction of Thousands of Tonnes of Glyphosate in the food Chain—An Evaluation of Glyphosate Tolerant Soybeans

“…seems to be relatively common and even 8-10 kg/ha (a.i.) can be expected under current farming conditions in Argentina, Brazil and Paraguay [52].…”

“…for soybeans. Based on the data available, Miyazaki et al [52] concluded that farmers' use of 6-7 kg/ha (a.i.) seems to be relatively common and even 8-10 kg/ha (a.i.)…”

Scientific advice on the Testbiotech's requests for internal review of Commission Implementing Decisions (EU) No 2019/2083 and 2019/2084 on soybean MON 89788 and soybean A2704‐12 (applications EFSA‐GMO‐RX‐011 and EFSA‐GMO‐RX‐009)

“…Following a request of the European Commission (EC), the European Food Safety Authority (EFSA) assessed the scientific content of the technical background of Testbiotech's requests for an internal review of the Commission Implementing Decisions (EU) No 2019/2083/2084 No 1367/2006, authorising the placing on the market of genetically modified soybean MON 89788 (application EFSA-GMO-RX-011) and soybean A27014-12 (application EFSA-GMO-RX-009).…”

“…One of the scientific arguments put forward in the technical background of the Testbiotech complaints is based on the recent publication by Miyazaki et al (2019) concerning the exposure levels of glyphosate-tolerant GM soybean plants to the complementary herbicide. Among other aspects, 13 Miyazaki et al (2019) consider the conditions under which the field trials in support of the authorisation of GM plants were conducted and conclude that they were not representative of the current farming practices.…”

“…With regards to animal feeding studies, EFSA reminds that the Miyazaki et al (2019) publication does not specifically analyse and comment on the study spontaneously provided in support of application EFSA-GMO-NL-2006-36 for soybean MON 89788. EFSA confirms that the considerations reported in Section 3.1.2 on the toxicological assessment of the whole GM food and feed from soybean MON 89788 are still valid.…”