European Union: Non-Authorised GMOs: Operation Of The Precautionary Principle

Last Updated: 8 January 2007
Article by Rob Greenhalf

Commission Decision on emergency measures regarding the non-authorised genetically modified organism LL RICE 601 in rice products1

INTRODUCTION

In August 2006, the European Commission issued a provisional Decision significantly restricting the importation of rice from the US, under fears that it may be contaminated with a strain of genetically modified rice. This issue highlights the precautionary approach currently taken by the EU authorities to issues relating to new technologies that have the potential to affect consumer health and safety in the EU.

BACKGROUND

The EU imports approximately 240,000 tons of long grain rice per year from the US. On 18 August 2006, the European Commission was notified by US authorities that contamination of some US-grown rice products by a genetically modified ("GM") rice strain (LL RICE 601) had been detected. The Commission acted promptly. On 23 August the Commission issued a provisional Decision requiring that all consignments of long grain rice products originating in the US be accompanied by an analytical report demonstrating them as being free from LL RICE 601 (2006/578/EC). Without such a report, 13 different US long grain rice products can no longer be placed on the market in the EU. The Decision also required that member states take appropriate measures to verify the absence of LL RICE 601 in products already on the market. An updated Decision issued on 5 September 2006 confirmed the earlier provisional Decision (2006/601/EC).

The emergency measures were taken by the Commission under the authority of Article 53(2) of Regulation (EC) 178/2002, which lays down the principles and requirements of food law.

Farmers in the US are reported to have filed lawsuits against Bayer CropScience2 for failing to prevent the unapproved GM rice from contaminating crops, leading to the EU and Japan imposing strict limits on imports and forcing down prices. Investigations are also under way in the US to determine whether any violations of US Department of Agriculture ("USDA") regulations occurred.

LL RICE 601 is not authorised to be placed on the market in the EU, and an application has only now been made in the US to "deregulate" the strain.3 The consignments in which trace amounts of LL RICE 601 were found are reported to have been grown in 2005. According to the Commission Decision, the contamination was reported to the US authorities on 31 July 2006 by Bayer CropScience.

As part of their obligations under EU general food law, the Federation of European Rice Millers trade group have reported detecting the GM rice in 33 of 162 samples tested up to 11 September. Preliminary tests by two member state authorities have also suggested that contaminated shipments have reached Europe.4 A further Decision has since been drafted by the Commission which will implement additional strict counter-testing measures. This step has been taken because Dutch authorities detected LL RICE 601 contamination in a batch that carried the newly required US certification stating it to be GM-free. A press release from Brussels stated

"US long grain rice imports will continue to be subject to the certification requirements when LL601 was first reported to be present in US rice in August. Under the draft Decision agreed by the Standing Committee today, in addition to this certification requirement, all consignments of US long-grain rice will also be sampled and tested at the point of entry to the EU by member state authorities."5

Responsibility for obtaining certification and the associated costs rest with the operators responsible for first placing food and feed on the market. They also will be liable for the costs of counter-testing that will be required under the additional Decision announced in October. Contaminated shipments must be returned to the US or destroyed. In line with EU general food law, business operators also are responsible for ensuring that the products they import or sell are certified as free from unauthorised GM products.

LL RICE 601

LL [LibertyLink®] RICE 601 was grown in field trials between 1998 and 2001 in the US, but was not developed commercially thereafter. The strain is the result of a genetic modification to render it tolerant to the herbicide glufosinate-ammonium which is sold as Liberty® herbicide. Tolerance is achieved by introducing into the rice plant genome a gene (bar) derived from the bacteria Streptomyces hygroscopicus. The bar gene6 codes for the manufacture of a protein (phosphinothricin acetyltransferase ("PAT")) that confers tolerance to the herbicide. The bar gene was introduced into the plant genome along with some widely used genetic control elements that regulate expression of the novel gene. Another LibertyLink® strain, LL RICE 62, has already been deregulated in the US, and is currently being assessed by the European Food Safety Authority ("EFSA") for authorisation in Europe.

Each of the introduced genetic components in LL RICE 601 and the resulting PAT protein are used in other GM food and feed crops that have already been granted marketing authorisations in the US and some other countries. Glufosinate-ammonium tolerant crops using the LibertyLink® system have long been approved for canola, soybean and maize crops in Canada and the US.

Following the reported contamination, two methods for the detection of LL RICE 601 were provided to analytical laboratories by Bayer CropScience. However, accurate quantification of the level of contamination is very difficult, and the EFSA has concluded that exposure levels in EU member states cannot accurately be estimated from the data available.7

RISK ASSESSMENT IN THE EU

The precautionary principle

The precautionary principle, which in general terms can be summarised by the maxim "better safe than sorry", is incorporated into EU food law in Article 7 of Regulation 178/2002. Article 7(1) states

"...where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment."

Article 7(2) adds that measures taken "shall be proportionate and no more restrictive to trade than is required to achieve the high level of health protection chosen in the community". These principles translate as a presumption of risk for GM products that have not been authorised under EC Regulation 1829/2003.

Safety concerns

Many of the safety concerns associated with GM crops are similar to those which may arise in relation to a traditionally developed strain. These include changes in nutritional quality or composition and the development of allergenic or toxic substances in the crop. Traditionally developed strains, however, are rarely subjected to scrutiny comparable to that of GM plants. When a plant is genetically modified, toxicity or allergenicity may arise if the product of the novel gene is itself harmful or if the inserted genes interfere with a native gene leading to the creation of a harmful gene product. Therefore at the molecular level, whilst a novel gene and its products may previously have been well characterised and their safety assessed in other crops or strains, for any particular GM strain the transformation event (namely how and where the genetic material inserts into the host genome), and therefore the risk profile, is unique. It is perhaps for this reason that Regulation 1829/2003 abandons the concept of "substantial equivalence" in food safety when considering the risks of GM products.8

The other major consideration in assessing the safety of a GM plant is its potential for wider environmental impact.9 The risk of adventitious (unplanned and uncontrolled) growth of LL RICE 601 in Europe is thought to be extremely low. Whilst some European countries grow rice commercially, the plants' growing conditions are specialised and they cannot survive the low temperatures that much of Europe experiences. The strain does not contain an antibiotic resistance marker, the presence of which has given rise to theoretical concerns of gene transfer to other strains and other species. The PAT protein is already present in the environment without known adverse consequences.

The PAT protein has been evaluated by the EFSA in previous unrelated applications, and is "considered not to pose any health concern". Safety approval has been granted for a strain of maize (1507 Maize) which contains the PAT protein, and applications are currently being reviewed for an oilseed rape plant containing the bar gene. Bayer CropScience has submitted applications to the EFSA requesting marketing approval for LibertyLink® cotton (LL Cotton 25) and, as mentioned above, LL RICE 62. In 2005, Bayer published the results of extensive scientific studies and a literature review on the safety of the bar gene and PAT protein.10 It concluded that no toxic or allergenic effects would be expected from consumption of the bar DNA sequence or the PAT protein. LL RICE 62 and LL RICE 601 use the same bar gene and share one of the control elements used to produce the PAT protein. Although deregulated by US authorities, LL RICE 62 has not yet been commercialised.

Since 18 April 2004, when GM food and feed applications in the EU became subject to Regulation 1829/2003, five GM plant strains have been approved. One of these, 1507 Maize (mentioned above), expresses the PAT protein to confer tolerability to glufosinate-ammonium, and four have been modified to provide tolerance to a different herbicide and/or pest-resistance. So far there are no GM strains of rice authorised for use in the EU.

Early in the LL RICE 601 contamination story, scientific advisory bodies from both the UK and the Netherlands concluded that the consumption of the rice did not pose a risk to human or animal health. Since then, the EFSA has stated that insufficient safety data are available on LL RICE 601 to allow a full risk assessment "according to EU standards". The EFSA Scientific Panel on Genetically Modified Organisms did, however, conclude

"...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 LL RICE 601 is not likely to pose an imminent safety concern to humans or animals."11

A press release issued by the USDA12 reported that both it and the US Food and Drug Administration had concluded that "there are no human health, food safety, or environmental concerns associated with this [genetically engineered] rice", and the USDA's Animal and Plant Health Inspection Service also concluded that the rice is safe in the environment.

Allowances

Regulation 1829/2003 on genetically modified food and feed contains a provision for the "adventitious or technically unavoidable presence of genetically modified material" on the EU market, and amends 2001/18/EC accordingly. Article 47 allows for the presence of up to 0.5% GMO in a food or feed product without authorisation being required, provided that it can be shown that its presence was adventitious or technically unavoidable and that it had benefited from a favourable opinion from the Community Scientific Committee(s) or Authority before the date of application of the Regulation (18 April 2004). The clause is a transitional one that will expire three years after the Regulation entered into force. Provision is also made for the adventitious or technically unavoidable presence of GMOs in food labelling laws. Article 12 states that where GM material forms 0.9% or less of a product, and this can be shown to be adventitious or technically unavoidable, then subsequent labelling requirements in Section 2 of the Regulation do not apply.

COMMENT

The risk to human or animal health through the contamination of US long grain rice products with traces of an unauthorised GM strain appears to be extremely small. Each component of the introduced genetic material and the resulting PAT protein have been well characterised and have, in various forms, received favourable regulatory safety approvals. Furthermore, millions of people have eaten GM products, including some carrying herbicide resistance, with no proven adverse health effects. The risk, if any, of environmental damage by the GM rice strain in Europe is likely to be negligible.

Despite this, the European Commission has introduced Decisions which in Europe have limited supplies, presumably caused the destruction or repatriation of large quantities of non-GM rice, and have been burdensome to member states and industry stakeholders. In the US, the measures have led or contributed to a fall in the value of crops, additional costs for producers to obtain certification and for counter-testing, and the issuing of damages claims by rice farmers against Bayer CropScience.

Is the Commission's response "proportionate and no more restrictive to trade than is required to achieve the high level of health protection chosen in the Community"?13 Its stance is clearly stated in a press release which followed notification of the contamination

"...the EU practices a very strict policy of only allowing GMOs which have undergone full scientific assessment and authorisation in the EU. Under EU legislation, even traces of unauthorised GMOs are illegal."14

The precautionary approach has been maintained by the Commission despite a substantial body of data supporting the safety of this GM plant, favourable opinions from US regulators, favourable preliminary opinions from some member state authorities and no scientific evidence to suggest that LL RICE 601 may pose a threat to human health.

A resolution to this apparent stalemate may not be easily achieved. Should Bayer CropScience seek to solve the situation by applying for authorisation in Europe for LL RICE 601, costly data probably not yet available may have to be collated for a strain not intended to be commercialised. Regardless, the approval process would take time. Alternative approaches to removing the restrictions will largely depend on the outcome of a USDA investigation into how the contamination occurred and how widespread the adventitious growth is. If it is not feasible to isolate and restrict the contaminated rice at source, the Commission has the choice of upholding the ban, or perhaps reconsidering the safety data already available and taking assurance from the considered opinions of US regulators.

Possibly of greatest concern in relation to this case is the fact that, despite having never been commercially grown, this GM plant has managed widely to contaminate cultivation and to enter the human food chain. Whilst all the available evidence for this particular plant indicates that the transformation event is perfectly safe, not all GM plants will necessarily be as safe for general consumption.

Rob Greenhalf, Science Unit, London
rob.greenhalf@lovells.com

Footnotes

1 2006/578/EC and 2006/601/EC.

2 In 2002 Bayer took over Aventis CropScience who developed and tested the LL RICE 601 strain.

3 Deregulation refers to the process in the US whereby a manufacturer of a GM crop, which has been subject to USDA regulation (as must all such crops which a manufacturer wishes to field-test or move), has gathered sufficient information in relation to that crop to demonstrate that it poses no threat to the environment or agriculture, and need no longer be regulated by the USDA.

4 European Commission Press Release IP/06/1175 (12 September 2006).

5 European Commission Press Release IP/06/1468 (25 October 2006).

6 The gene is the genetic code that provides specific instructions, or a blueprint, from which the plant produces the PAT protein.

7 Statement of the Scientific Panel on Genetically Modified Organisms in response to the request of the European Commission on inadvertent presence of genetically modified rice LLRIC601 (14 September 2006).

8 "Substantial equivalence" is a concept that has been developed as part of a safety evaluation framework, based on the idea that existing foods can serve as a basis for comparing the properties of genetically modified foods with the appropriate counterpart.

9 Detailed principles for an environmental risk assessment are provided in Annex II of Directive 2001/18/EC on the deliberate release into the environment of Genetically Modified Organisms.

10 Herouet, C et al (2005) Safety evaluation of the phosphinothricin acetyltransferase proteins encoded by pat and bar sequences that confer tolerance to glufosinate-ammonium herbicide in transgenic plants. Regulatory Toxicology and Pharmacology. Vol.41; 134-149.

11 Statement of the Scientific Panel on Genetically Modified Organisms in response to the request of the European Commission on inadvertent presence of genetically modified rice LLRIC601 (14 September 2006).

12 Release No. 0307.06. Statement issued by Agriculture Secretary Mike Johanns (18 August 2006).

13 (EC/178/2002. Art.7(2)).

14 Questions and Answers on the finding of unauthorised GM rice on the US market. Reference: MEMO/06/310 (23 August 2006).

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * **

Lovells' Science Unit was founded in 1996 to provide expert scientific support to lawyers within the group, particularly in the product liability and regulatory fields, and patent disputes. It is built around post-doctoral/graduate scientists with qualifications in a range of disciplines, including physiology, developmental biology and biotechnology.

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