EFSA is currently assessing this Monsanto application, and is waiting for extra information as requested. It will be interesting to see what they have asked for, and why. But from this assessment of the Monsanto dossier, made for Norway's Centre for Biosafety and submitted to the Norwegian regulator, it looks as if the dossier contains the usual mix of bad science, dodgy experimental design, improper assumptions, inadequate data, and improper use of comparators. The authors are highly critical of the quality of the dossier, and it looks -- yet again -- as if there is deliberate scientific fraud going on, in the hope that the regulators will not pick up on it. Interestingly enough, the advice from the authors of this assessment is that "Codex Alimentarius guidelines allow Norway to ask for specific data of the type we identify and recommend obtaining below. Norway therefore may request this information without concern of a challenge from the World Trade Organisation." Further, "it is highly questionable whether the intended changes in fatty acid profiles caused by the modification is demanded or needed within the Norwegian diet, thus there are no net benefits to Norwegians."
The citation of Codex Alimentarius is a fascinating precedent, which many experts have been calling for over the past year or two. Will EFSA now do the same? We have our doubts.......
by Centre for Biosafety – GenØk and Center for Integrated Research in Biosafety September 2010
Authors: Prof. Jack Heinemann Dr. Brigitta Kurenbach Dr. David Quist
Assessment of the technical dossier related to EFSA/GMO/NL/2010/78
The following information is respectfully submitted for consideration in the evaluation of product safety and corresponding impact assessment of MON 87705, setting out the risk of adverse effects on health and the environment and other consequences of proposed release under the pertinent Norwegian regulations. This submission was built in large part using the Biosafety Assessment Tool (https://bat.genok.org/bat/) produced by the University of Canterbury and GenØk – Centre for Biosafety. This is a free-to-the-public resource for hazard identification and risk assessment of genetically modified organisms. All page numbers refer to the document Part 1 of the technical dossier “Application for authorization to place on the market MON 87705 soybean in the European Union, according to Regulation (EC) No 1829/2003 on genetically modified food and feed” submitted by the Developer. This submission is structured to provide reference to specific provisions for an impact assessment required under the Norwegian Gene Technology Act of April 1993, focusing on the requirements in Appendix 2 - Principles for environmental risk assessment pursuant to sections 13-16 of the regulations and Appendix 4 - Evaluation of ethical considerations, sustainability and benefit to society, cf section 17 of the “Regulations relating to impact assessment pursuant to the Gene Technology Act” of December 2005, pursuant to section 11 cf section 8. The information presented here may be applicable to more than one provision in different appendices, including those not specifically mentioned. We focused our critique to address the information needs under the relevant provisions that relate to our particular area of competence in biotechnology assessment as comprehensively as possible, and lack of commentary on our part towards any information under consideration should not be interpreted as specific endorsement of that information. Lastly, Codex Alimentarius guidelines allow Norway to ask for specific data of the type we identify and recommend obtaining below. Norway therefore may request this information without concern of a challenge from the World Trade Organisation.
Summary of key findings
After a detailed analysis of many of the portions of the dossier on MON87705 submitted by the Developer, we outline a number of methodological and conceptual weaknesses contained in the dossier, including: • improper assumptions; • weakness in study design and/or methodology that bias against the detection of differences; • lack information on potential relevant adverse effects; and • improper use of comparators. These weaknesses seriously undermine any scientifically justified conclusion of safety and therefore should be addressed by requests for new information.
1. The rates, types and pathways of exposure to MON 87705 have not been sufficiently characterized by the Developer. This is essential information to properly characterize risk.
2. The Developer has not addressed several important health issues or substantiated its claims of benefits to be derived from use of MON 87705, including the combinatorial (in food) or cumulative (in environment) effects of both high oleic acid levels and unintended increases and decreases in other fatty acids. This may be of significance for those who suffer from, or are prone to, acute respiratory distress, as elevated fatty acids are associated with the disease or its symptoms and when inhaled can irritate the lungs.
3. Critically, the Developer has not provided a convincing case for having either identified or analyzed off-target effects of the novel dsRNAs expressed in soybean MON 87705, or other unintended metabolic changes.
4. It is significant that the Developer has not excluded the production of novel small peptides being produced by regular but low level expression of intended dsRNAs. The Developer has only argued that they do not exist, and this argument lacks scientific basis. Thus, the molecular characterization is unsatisfactory for concluding that there are no novel protein-based hazards.
5. The standards used for equivalence testing of surrogate proteins in the assessment lack substantive rigor to draw relevant conclusions. The methods and study designs employed by the Developer, in our view, bias against identification of differences.
6. Concerning the social utility of MON 87705 outlined in Appendix 4 Part V, it is highly questionable whether the intended changes in fatty acid profiles caused by the modification is demanded or needed within the Norwegian diet, thus there are no net benefits to Norwegians and merits further attention.
When it comes to considering the benefits to Norwegians of approving MON 87705, we encourage the Direktoratet for naturforvaltning to take a holistic view. The harm of using conventional soybeans in human food comes from overconsumption or substitution of soybean derived oils for oils more fit for purpose. The solution to these problems, particularly exposure to trans fats, is not alteration of the Norwegian food supply by introduction of novel products from overseas agroecosystems, but a commitment to providing good food and social programs that encourage healthy eating.
Summary of recommendations
We propose a number of recommendations, summarized here and detailed in the critique below.
The Direktoratet for naturforvaltning is encouraged to:
1. Rigorously pursue its right to request experimental data from the Developer to answer the questions raised in this submission, before concluding that a rejection would not be justified on the basis of safety.
2. Request from the Developer an exposure analysis that includes consumption by age, sex and ethnic group of Norwegian consumers; and both data on currently consumed amounts of conventional soybean oil and maximum possible consumption of high oleic acid soybean oil, including consumption patterns that might eventuate from new applications of this oil in Norway.
3. Require information from the Developer on the effects of MON 87705 inhalation in animals used as models of acute respiratory syndrome, compared with inhalation of the proper conventional comparator. This should include allergenicity and toxicity analyses.
4. Request a detailed analysis of the structural and functional characteristics and bioactivity of the novel 9,15 isomer likely produced in MON 87705.
5. Request a full chemical compositional description of whole foods prepared under a range of normal cooking and processing conditions using oil derived from MON 87705 and compared to oil from the proper conventional comparator line. This should be followed by animal feeding studies using whole foods produced using these two sources of oil.
6. Request information from the Developer on microbial exposure routes including the effects of oleic acid on environmental flora (particularly those microorganisms that may flow through to human food) and the dietary effects on human flora, particularly the ability of increased exposure to select for resistance and cross- resistance to clinical antibiotics and antiseptics.
7. Request a demonstration the effect from transient expression of the expected RNA hairpin (using a non-integrated construct) or RNAi from transformation with hairpin RNA alone is the causative agent for the intended phenotype.
8. Request information from the Developer on all RNA molecules unique to MON 87705, or at unique concentrations in MON 87705. Moreover, that information should be informed by appropriate high throughput sequencing methodologies.
9. Request a demonstration that unintended dsRNAs—which may still be unknown— produced in the MON 87705 soybean or secondarily in human cells have no adverse effects.
10. Request that the Developer describe all off-target changes to gene expression in MON 87705, and the potential for the novel RNA molecules (or molecules at novel concentrations), and possible derivatives that may be made in human cells, to cause effects on human cells.
11. Require the Developer to monitor ongoing nucleotide-level changes in the transgene and subsequent changes to the off-target effects of the dsRNA in MON 87705, if it is approved for commercial use. In the absence of such monitoring, approval should be conditional and limited to a period of no more than three years.
12. Request a compositional analysis of MON 87705 be provided from plants grown under intended commercial cultivation methods and compared to its conventional parent when grown under its intended commercial cultivation methods.
13. Request justification and scientific evidence for the criteria chosen by the Developer for inferring biochemical and safety equivalence of E. coli- and MON 87705– derived CP4 EPSPS were appropriate.
14. Request data from proper immunostimulation and allergenicity testing of MON 87705 including tests from diet and inhalation exposures. A proper comparator would include the product produced under intended use conditions. Comparisons using immune sera from subjects sensitized to conventional soy are not capable of detecting immune