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Background

The European Food Safety Authority (EFSA) received a request from the European Commission, dated 25 August 2006, for scientific support on the issue of the inadvertent release in the United States and potential export into the EU of rice containing a genetically modified (GM) rice line called LLRICE601 that has not been authorized for release into the US or EU markets.

On 18th August, the European Commission was informed by the US authorities about the detection of the GM rice in long grain samples of commercial rice which may have entered the food and feed supply in the US. The US Department of Agriculture (USDA) and the US Food and Drug Administration (FDA) have stated that the inadvertent presence of LLRICE601 poses no safety concerns and a draft environmental risk assessment report was posted on the USDA website[1][2][3]. The Commission immediately requested scientific data related to the safety of this GM rice. On 22nd August, the US authorities provided a summary risk assessment of LLRICE601 after evaluation of a data package submitted by Bayer Crop Science, the biotechnology company that has developed the rice.

The Commission has requested EFSA “to examine the data from the company and the US and to provide, by the end of September, scientific support on the safety of LLRICE601 and to assess, whether these data are sufficient to allow a safety assessment to be carried out according to EU legislation”. Meanwhile the European Commission, supported by the Member States, has taken an emergency measure[4] requiring imports from the US of long grain rice to be used as human and animal feed to be certified as free of LLRICE601. The company has recently sought deregulation[5] of LLRICE601 in the US, as an extension to the earlier petition for LLRICE62 and LLRICE 06, two other GM rice events with similar characteristics. The company did not request a market authorisation for LLRICE601 in the EU. An application for marketing LLRICE62 in the EU is currently under evaluation by EFSA[6]. The advisory bodies of the UK and the Netherlands have recently advised that the consumption of rice containing traces of LLRICE601 does not pose risks for human and animal health[7].

Evaluation of available data

LLRICE601 has been developed for tolerance to the Liberty® herbicide. It was produced by insertion of a chimeric bar gene (originally from Streptomyces hygroscopicus) which encodes the enzyme phosphinothricin N-acetyltransferase (PAT) through Agrobacterium-mediated transformation. PAT confers tolerance to the phytotoxic activity of glufosinate ammonium, the active ingredient of Liberty. The rice was field-tested by the Louisiana State University in the US from 1999 to 2001, as backup line in breeding activities but was not developed further for commercialisation. According to the USDA and company data, this rice event is very similar to the GM rice events, LLRICE62 and LLRICE06, which are authorised for the US market but have not yet been commercialised. These events have the same trait, i.e tolerance to glufosinate ammonium, but have been obtained using different transformation methods and vectors.

As LLRICE601 apparently was not intended to be developed further for commercial purposes, the data package available is insufficient to allow a full risk assessment of LLRICE601 according to EU standards. Although extensive data have been presented regarding the molecular characterisation of the intended insert, no full molecular characterization was presented and only limited summary data have been provided regarding the compositional analysis of the rice and agronomic and nutritional equivalence to conventional rice. It is therefore not possible to conclude on the safety of LLRICE601 itself, in accordance with the EFSA guidance for risk assessment[8].

On the basis of the available data, the following evaluation is presented:

Information submitted on the newly inserted genetic material and the protein characterisation confirmed the presence in LLRICE601 of a single bar gene conferring herbicide tolerance, flanked by the 35S promoter from Cauliflower Mosaic Virus and a truncated 3' untranslated end of the nopaline synthase gene (3'nos) from Agrobacterium tumefaciens. A second copy of the 35S promoter or part of it is inserted. Bioinformatic analysis by the company of the regions flanking the bar gene suggests that no known rice gene was interrupted and that no chimeric proteins would be expressed due to the gene insertion. Such an analysis was not performed for the second insertion containing 35S promoter sequences.

The data package indicates that a PAT protein is expressed in LLRICE601. Other PAT proteins have been assessed by the GMO Panel in various applications and are considered not to pose any health concern.

With respect to morphology, agronomic performance and compositional analysis, the USDA and company assessments states that LLRICE601 does not differ significantly from conventional rice, except for the introduced trait. The company stated that there were no indications of unintended changes due to the genetic modification. The data package does not include the required raw data to verify this assumption.

Currently, little is known with respect to the source and the extent of the inadvertent presence of LLRICE601 in the rice supply. The USDA is investigating this issue. The Louisiana State University has communicated that trace amounts of LLRICE601 were found in a sample of the foundation seed stock of 2003 of one long grain variety (Cheniere) but not in following years[9]. The adventitious presence has not been reported in medium or short-grain rice.[10] The national control laboratories and the Federation of European Rice Millers (FERM) are currently undertaking sampling and testing, using the PCR-based methods provided by Bayer, that allow for specific detection of LLRICE601. These methods have been validated by the USDA and verified by the Community Reference Laboratory of the EU[11]. Preliminary data by FERM have revealed an incidence of 33 out of 162 samples which tested positive for the gene construct[12]. Preliminary reports from US rice producers indicate that the level of adventitious presence of LLRICE601 might be below 0.1% (Riceland reported 0.06% i.e. 6 in 10000 seeds). Exposure levels in the EU Members States cannot be estimated accurately from the data provided.

Conclusions

The available data are not sufficient to allow the safety of LLRICE601 to be assessed in accordance with the EFSA guidance for risk assessment. However, on the basis of the available molecular and compositional data and on the toxicological profile of PAT proteins, EFSA considers that the consumption of imported long grain rice containing trace levels of LLRICE601 is not likely to pose an imminent safety concern to humans or animals.



[1] http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1RD?printable=true&contentidonly=true&contentid=2006/08/0307.xml 
[2] http://www.cfsan.fda.gov/~lrd/biorice.html 
[3] http://www.aphis.usda.gov/brs/aphisdocs/06_23401p_pea.pdf 
[4] http://eur-lex.europa.eu/LexUriServ/site/en/oj/2006/l_244/l_24420060907en00270029.pdf 
[5] http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/fs_biodereg.pdf
[6] The process is currently on hold as EFSA is awaiting further data/clarifications from the applicant
[7] http://www.foodstandards.gov.uk/news/newsarchive/2006/sep/gmricetest and 
http://www2.vwa.nl/portal/page?_pageid=35,1554101&_dad=portal&_schema=PORTAL&p_file_id=12446
[8] http://www.efsa.europa.eu/en/science/gmo/gmo_guidance/660.html 
[9] http://www.lsuagcenter.com/en/communications/news/headline_news/Liberty+Link+601+Found+In+LSU+
AgCenter+Foundation+Seed+Rice.htm 
[10] http://www.calrice.org/downloads/newsreleases/LL-RES-Results-NR.pdf 
[11] http://gmo-crl.jrc.it/LLRice601update.htm 
[12] http://europa.eu.int/rapid/pressReleasesAction.do?reference=IP/06/1175&format=HTML&aged=0&language=EN&guiLanguage=en