In 1994, the Advisory Committee on Novel Foods and Processes (ACNFP) reviewed the food safety of genetically modified (GM) soya beans and derived products developed by Monsanto. The Committee recommended safety clearance for the glyphosate tolerant line 40-3-2, which had been modified to contain the epsps gene, and its descendants from crosses with non-GM lines produced through conventional plant breeding. The Committee's report was published in its 1994 Annual Report and the information submitted by Monsanto was deposited in the British Library.
In December 1997, the ACNFP was asked to consider a paper that was submitted to the Minister of State by Greenpeace. In the paper, Greenpeace described the granting of a marketing consent for line 40-3-2 as "regulatory negligence". Points presented in Greenpeace's paper of relevance to the ACNFP's consideration of the food safety of this line are discussed in the sequence presented in the paper.
Monsanto had submitted no toxicological assessments
Wherever possible, the ACNFP uses a comparative approach to establish the safety of a novel food. This requires the novel food to be compared with a conventional equivalent; usually in the case of a genetically modified organism (GMO) this is with its non-GM parent. In the first instance, compositional data relating to nutritional and toxicological parameters are compared. Should concerns be identified, further studies will be requested. With the introduction of the Novel Foods Regulation, this approach has been formalised throughout the EU in the application of the concept of "substantial equivalence".
The ACNFP concluded that the GM soya beans were safe after its rigorous examination of the detailed compositional and nutritional data that had been submitted. The Committee was satisfied from the evidence provided that the GM soya beans were as safe as conventional beans and that additional toxicological studies would not be necessary.
Monsanto had submitted no independent verification of its conclusions and no peer review of its methodology
The ACNFP has always required that data submitted for assessment is to Good Laboratory Practice (GLP) standards. Monsanto submitted data that had been quality assured to these standards. Under GLP all studies must follow written standard procedures and all laboratory records and samples must be archived. All laboratory facilities are inspected by independent inspectors.
The ACNFP's approach, based on the comparison of a GM food with its traditional counterpart has been subject to wide consultation, most recently when the Committee revised its structured schemes. The application of the concept of substantial equivalence, a concept that was developed by the WTO, has been subject to extensive peer review.
Genetic stability is a key aspect of the ACNFP's safety consideration. Indeed because there is currently little expertise in predicting the effect of genetic drift on the metabolism of any lines of plants, whether GM or conventionally bred, the ACNFP requires all applicants to provide periodic updates to substantiate the long term stability of GM lines.
Data obtained from soya that had not been treated with glyphosate
The ACNFP was satisfied that the composition of the GM soya was equivalent to that of non-GM soya and that there were no unintended effects as a result of the genetic modification. Data on soya treated with glyphosate was reviewed by the ACNFP and other EU competent authorities and raised no concerns.
Monsanto carried out an immunoblot assay on the GM soya beans, their non-GM parental line and three commercially available soya flour preparations. This assay is routinely used in the assessment of soya bean allergens and involves detection using IgE antibodies derived from serum from individuals known to be sensitive to soya beans through direct food challenges. The presence and relative levels of endogenous allergenic proteins in all of the preparations were comparable.
In addition, the CP4 EPSPS protein, which is produced by the introduced gene, was extensively tested. It was shown to be inactivated and denatured by heating, rapidly inactivated by mammalian digestive fluids, unglycosylated and database searches showed no significant homology to any protein allergens.
Denaturation of the EPSPS protein by heat treatment
Monsanto supplied data to demonstrate that all detectable functional activity and ELISA reactivity of the EPSPS protein was lost following the toasting procedure used to process soya beans. Although a portion of the protein mass was still detectable by immunoblot assay after the heat treatment, the tests indicated that the tertiary structure had been altered; the protein molecule was denatured and was no longer functional.
As discussed in (8) Monsanto had provided evidence to demonstrate that the EPSPS protein is not allergenic.
History of safe use
As part of the conditions of clearance of the GM soya bean, Monsanto undertook to review compositional data to ensure that the GM beans remained genetically stable. The first of these reports have been received which indicate that there no significant differences between the GM soya beans and the non-GM lines analysed.
Allergic reactions to foods in adults with no history of food allergies
The ACNFP was satisfied that Monsanto had demonstrated that the presence and relative levels of endogenous allergenic proteins in preparations of GM and non-GM soya beans were comparable.
The issues regarding environmental safety were addressed by the Advisory Committee on Releases to the Environment (ACRE) when assessing the application for a marketing consent under the Deliberate Release Directive 90/220/EEC. Since the GM soya was not intended for cultivation in the UK or Europe, the issues raised by Greenpeace regarding the changes in herbicide usage do not fall within the remit of the ACNFP.
The ACNFP rejects the Greenpeace allegation of regulatory negligence and reiterates its original conclusion that beans and derived products from GM line 40-3-2, and from its descendants from crosses with non-GM lines produced through conventional plant breeding, were as safe for human consumption as beans derived from other conventional soya bean lines.