1: Nature. 2007 Jan 11;445(7124):132-3. Out of bounds. [No authors listed] Publication Types: News PMID: 17215811 [PubMed - indexed for MEDLINE] 2: Ig Sanita Pubbl. 2005 Sep-Oct;61(5):475-96. [Genetically modified organisms: European and Italian legislation to protect citizens' health] [Article in Italian] Sotgiu A, Tala M, Sardu G, Coroneo V, Dessi S, Contu P. Dipartimento di Sanita Pubblica, Universita di Cagliari. The development of GM foods and organisms has concentrated everyone's attention on the importance of food safety and on protecting citizens' health, and inevitably influenced healthcare policies regarding food safety. Personal ethical beliefs regarding food and in particular, the consumption of foods derived from biotechnology should be taken into account when deciding healthcare policy. AIM: The aim of this study was to analyse whether European, Italian and Regional legislation meets basic human rights regarding health and the right to choose, based on the precautionary principle. METHODS: European and Italian laws regarding the production and marketing of GM foods were analysed and compared to food safety legislation, in order to evaluate how and to what degree existing legislation protects consumers' right to choose. Results show that existing legislation protects consumers from possible foodborne diseases, but the right to informed consent and to free choice is not warranted. Existing laws do not attach enough importance to consumers' right to information; arbitrary threshold levels set for labeling and clauses concerning technical causes allow food businesses to avoid labeling and do not give consumers the possibility of making an informed choice. Publication Types: English Abstract PMID: 17206218 [PubMed - indexed for MEDLINE] 3: Risk Anal. 2006 Dec;26(6):1707-19. Exploring the structure of attitudes toward genetically modified food. Poortinga W, Pidgeon NF. Cardiff University, Welsh School of Architecture, Cardiff, Wales, UK. PoortingaW@Cardiff.ac.uk Although it is often thought that the British public is opposed to genetically modified (GM) food, recent qualitative work suggests that most people are ambivalent about GM food and crops. In this article we explore the structure of attitudes in order to examine whether attitudinal ambivalence can be captured by more quantitative methods. Based on the finding that the perceived risks and benefits of GM food can be treated as independent dimensions, we propose a four-way typology of attitudes, consisting of a positive, negative, indifferent, and ambivalent group. This study showed that the differences between the four groups could best be described by three main dimensions: (1) a general evaluative dimension, (2) an involvement dimension, and (3) an attitudinal certainty dimension. While these different attitudinal dimensions have generally been studied in isolation, we argue that they should be studied collectively. Publication Types: Research Support, Non-U.S. Gov't PMID: 17184407 [PubMed - in process] 4: Plant Biotechnol J. 2006 Mar;4(2):263-73. Characterization of a higher plant herbicide-resistant phytoene desaturase and its use as a selectable marker. Arias RS, Dayan FE, Michel A, Howell J, Scheffler BE. USDA-ARS, Natural Products Utilization Research Unit, PO Box 8048, University, MS 38677, USA. Three natural somatic mutations at codon 304 of the phytoene desaturase gene (pds) of Hydrilla verticillata (L. f. Royle) have been reported to provide resistance to the herbicide fluridone. We substituted the arginine 304 present in the wild-type H. verticillata phytoene desaturase (PDS) with all 19 other natural amino acids and tested PDS against fluridone. In in vitro assays, the threonine (Thr), cysteine (Cys), alanine (Ala) and glutamine (Gln) mutations imparted the highest resistance to fluridone. Thr, the three natural mutations [Cys, serine (Ser), histidine (His)] and the wild-type PDS protein were tested in vitro against seven inhibitors of PDS representing several classes of herbicides. These mutations conferred cross-resistance to norflurazon and overall negative cross-resistance to beflubutamid, picolinafen and diflufenican. The T3 generation of transgenic Arabidopsis thaliana plants harbouring the four selected mutations and wild-type pds had similar patterns of cross-resistance to the herbicides as observed in the in vitro assays. The Thr304 Hydrilla pds mutant proved to be an excellent marker for the selection of transgenic plants. Seedlings harbouring Thr304 pds had a maximum resistance to sensitivity (R/S) ratio of 57 and 14 times higher than that of the wild-type for treatments with norflurazon and fluridone, respectively. These plants exhibited normal growth and development, even after long-term exposure to herbicide. As Thr304 pds is of plant origin, it could become more acceptable than other selectable markers for use in genetically modified food. PMID: 17177802 [PubMed - indexed for MEDLINE] 5: Biotechnol J. 2006 Dec;1(12):1433-4. Consumer acceptance of ingenic foods. Lusk JL, Rozan A. Department of Agricultural Economics, Oklahoma State University, Stillwater, OK, USA. jayson.lusk@okstate.edu Recent advances in plant molecular biology offer a means of reaping the benefits of biotechnology, while potentially assuaging consumer concerns by re-inserting native DNA back into plants. Results are presented from nationwide surveys in the U.S. and France, indicating that more consumers would accept ingenic plants than transgenic plants, with twice as many U.S. than French consumers considering food produced through biotechnology eatable. PMID: 17124706 [PubMed - indexed for MEDLINE] 6: J Agric Food Chem. 2006 Nov 29;54(24):8984-94. Applications of metabolomics in agriculture. Dixon RA, Gang DR, Charlton AJ, Fiehn O, Kuiper HA, Reynolds TL, Tjeerdema RS, Jeffery EH, German JB, Ridley WP, Seiber JN. Plant Biology Division, Samuel Roberts Noble Foundation, 2510 Sam Noble Parkway, Ardmore, OK 73401, USA. Biological systems are exceedingly complex. The unraveling of the genome in plants and humans revealed fewer than the anticipated number of genes. Therefore, other processes such as the regulation of gene expression, the action of gene products, and the metabolic networks resulting from catalytic proteins must make fundamental contributions to the remarkable diversity inherent in living systems. Metabolomics is a relatively new approach aimed at improved understanding of these metabolic networks and the subsequent biochemical composition of plants and other biological organisms. Analytical tools within metabolomics including mass spectrometry (MS) and nuclear magnetic resonance (NMR) spectroscopy can profile the impact of time, stress, nutritional status, and environmental perturbation on hundreds of metabolites simultaneously resulting in massive, complex data sets. This information, in combination with transcriptomics and proteomics, has the potential to generate a more complete picture of the composition of food and feed products, to optimize crop trait development, and to enhance diet and health. Selected presentations from an American Chemical Society symposium held in March 2005 have been assembled to highlight the emerging application of metabolomics in agriculture. Publication Types: Review PMID: 17117782 [PubMed - indexed for MEDLINE] 7: Nat Biotechnol. 2006 Nov;24(11):1329; author reply 1331-3. Comment on: Nat Biotechnol. 2006 Jul;24(7):753. 'Cisgenic' as a product designation. Giddings LV. Publication Types: Comment Letter PMID: 17093471 [PubMed - indexed for MEDLINE] 8: Nat Biotechnol. 2006 Nov;24(11):1329-31; author reply 1331-3. Comment on: Nat Biotechnol. 2006 Jul;24(7):753. 'Cisgenic' as a product designation. de Cock Buning T, Lammerts van Bueren ET, Haring MA, de Vriend HC, Struik PC. Publication Types: Comment Letter PMID: 17093470 [PubMed - indexed for MEDLINE] 9: Nat Biotechnol. 2006 Nov;24(11):1327-9; author reply 1331-3. Comment on: Nat Biotechnol. 2006 Jul;24(7):753. 'Cisgenic' as a product designation. Schubert D, Williams D. Publication Types: Comment Letter PMID: 17093469 [PubMed - indexed for MEDLINE] 10: Nature. 2006 Nov 9;444(7116):137. A breed apart. [No authors listed] PMID: 17093424 [PubMed - indexed for MEDLINE] 11: J Allergy Clin Immunol. 2006 Nov;118(5):1176-83. Epub 2006 Sep 8. Reduced allergenicity of tomato fruits harvested from Lyc e 1-silenced transgenic tomato plants. Le LQ, Mahler V, Lorenz Y, Scheurer S, Biemelt S, Vieths S, Sonnewald U. Department of Biochemistry, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany. BACKGROUND: Profilin is a small actin-binding protein that contributes to the allergenic potency of many fruits and vegetables, including tomato. Two highly similar genes encoding tomato profilin have been isolated and designated as allergen Lyc e 1.01 and Lyc e 1.02. OBJECTIVE: The aim of the study was to generate profilin-reduced hypoallergenic tomato fruits by silencing of both genes in transgenic tomato plants by means of RNA interference (RNAi). METHODS: The efficiency of gene silencing was documented by means of Northern blotting, immunoblotting, and skin prick testing. RESULTS: Quantification of the remaining protein revealed that profilin accumulation in transgenic fruits was decreased 10-fold compared with that seen in untransformed controls. This decrease was sufficient to cause a reduced allergenic reactivity in patients with tomato allergy, as determined with skin prick tests. Because most patients with tomato allergy are not monosensitized to profilin, the IgE reactivity to the profilin-silenced tomato fruits in vivo varied widely between individuals tested. CONCLUSION: We could demonstrate the efficient silencing of both profilin genes in transgenic tomato plants using RNAi. This resulted in Lyc e 1-diminished tomato fruits, providing proof of concept and demonstrating that RNAi can be used to design allergen-reduced food. However, simultaneous silencing of multiple allergens will be required to design hypoallergenic tomatoes. CLINICAL IMPLICATIONS: Our findings demonstrate the feasibility of creating low-allergenic food by using RNAi. This concept constitutes a novel approach to allergen avoidance. Publication Types: Research Support, Non-U.S. Gov't PMID: 17088146 [PubMed - indexed for MEDLINE] 12: J Vet Med Sci. 2006 Oct;68(10):1113-5. Effects of feeding calves genetically modified corn bt11: a clinico-biochemical study. Shimada N, Murata H, Mikami O, Yoshioka M, Guruge KS, Yamanaka N, Nakajima Y, Miyazaki S. Safety Research Team, National Institute of Animal Health, Ibaraki, Japan. Genetically modified corn Bt11 is insect-resistant and expresses Cry1Ab toxin, an insecticidal protein, in kernels. Although Bt11 corn is considered safe based on animal performance, there are no reports available on the clinico-biochemical effects of feeding it to cattle. In this study, we evaluated the effects of feeding Bt11 to calves, using blood and ruminal clinico-biochemical parameters. Our three-month-long feeding experiment demonstrated that calves (n=6), fed with a ration containing 43.3% of Bt11 corn kernels as dry matter, did not develop any discernible clinical, hematological, biochemical, or ruminal abnormalities as compared with control calves (n=6) fed non-Bt11 corn. The results suggest that the transgenic Bt11 has no negative clinico-biochemical effects on calves. Publication Types: Randomized Controlled Trial Research Support, Non-U.S. Gov't PMID: 17085894 [PubMed - indexed for MEDLINE] 13: Med Law. 2006 Sep;25(3):491-502. Biotechnology entrepreneurship and ethics: principles, paradigms, and products. Kuszler PC. University of Washington School of Law, William H Gates Hall, Seattle, USA. Biotechnology, whether in the context of new drugs derived from DNA and genetic technology, genetically modified food, or biologics making use of living cells, raises ethical concerns at a variety of different levels. At the research level, there is concern that the very nature of research is being subverted, rather than enhanced, by entrepreneurship. This area of ethical concern has intensified in the United States as a result of the conflicts of interests resulting from the growing alliance between University academia and private industry in the research enterprise. As we travel down the research path into development of a drug or technology, ethical questions arise with respect to protecting human subjects and society from danger and exploitation by researchers. As development gives way to marketing and dissemination of a new product, government regulators are pressed to get drugs and biologics through the regulatory pipeline into the market faster, walking an ethical tightrope between speed and safety. As new biotechnology products enter the market place, doctors and patients traverse yet another tightrope, that between unknown risk and the promise of benefit. And finally, patent protection is increasingly viewed as a unethical culprit in keeping prices high and depriving the global poor from lifesaving drugs and biologics. Bioethics has, to date, been largely a creation of Western research and medicine. As such it is wholly inadequate to respond to the cascade of ethical issues that flow from a vibrant biotechnology industry. And if biotechnology is in its infancy, as most believe, it is crucial that scientists, entrepreneurs and governments engage in dialogue about the ethical and societal questions raised on the road of scientific progress. PMID: 17078522 [PubMed - indexed for MEDLINE] 14: Gig Sanit. 2006 Jul-Aug;(4):7-11. [Hygienic characteristics of foodstuffs containing genetically modified components] [Article in Russian] Beliaev EN, Ivanov AA, Fokin MV. The paper analyzes the results of the investigations of raw foods, foodstuffs for genetically modified components, conducted by the state sanitary and epidemiological service of the Russian Federation during its current sanitary inspection. The presented materials cover 2003-2004. The findings suggest that there is a great deal of foods containing genetically modified sources on the market and show the priority groups of foodstuffs and the distribution of these foods on the territory of the Russian Federation. Publication Types: English Abstract PMID: 17078283 [PubMed - indexed for MEDLINE] 15: J Agric Food Chem. 2006 Nov 1;54(22):8640-7. Safety assessment of cre recombinase. Hileman RE, Bonner HK, Kaempfe TA, Hammond BG, Glenn KC. Monsanto Company, St. Louis, Missouri 63167, USA. ronald.e.hileman@monsanto.com Cre recombinase, when used as a tool in agricultural biotechnology, can precisely excise DNA sequences that may be useful in the introduction of a new trait but are not needed in the commercial product. Although the cre genetic material would not be present in the final product, the present studies were performed to assess the safety of Cre recombinase to provide confirmatory evidence of the safe use of Cre-lox technology in agricultural biotechnology. Cre recombinase shares no relevant sequence similarity to known allergens or toxins. When Cre recombinase was exposed to a pH 1.2 solution of simulated gastric fluid lacking pepsin, CD spectroscopy showed that there was a loss of secondary structure and that the protein was no longer active in a functional assay. Cre recombinase was degraded rapidly when exposed to pepsin in a standardized gastric digestion model; therefore, Cre recombinase would not survive the harsh gastric environment. When orally administered to mice as an acute dosage of 53 mg/kg of body weight, no treatment-related adverse findings were observed. These data support the conclusion that human and animal dietary exposure to Cre recombinase pose no known safety concerns; consistent with the fact that bacteriophage P1, the source of the cre gene and expressed protein, is commonly encountered in the environment and in normal enteric bacteria without reports of adverse consequences. PMID: 17061845 [PubMed - indexed for MEDLINE] 16: J Agric Environ Ethics. 2006;19(3):253-67. Including public perspectives in industrial biotechnology and the biobased economy. Paula L, Birrer F. Institute of Biology, Biology and Society, Leiden University, PO Box 9516, 2300 RA Leiden, The Netherlands. lepaula@rulsfb.leidenuniv.nl Industrial ("white") biotechnology promises to contribute to a more sustainable future. Compared to current production processes, cases have been identified where industrial biotechnology can decrease the amount of energy and raw materials used to make products and also reduce the amount of emissions and waste produced during production. However, switching from products based on chemical production processes and fossil fuels towards "biobased" products is at present not necessarily economically viable. This is especially true for bulk products, for example ethanol production from biomass. Therefore, scientists are also turning to genetic modification as a means to develop organisms that can produce at lower costs. These include not only micro-organisms, but also organisms used in agriculture for food and feed. The use of genetic modification for "deliberate release" purposes, in particular, has met great opposition in Europe. Many industrial biotechnology applications may, due to their scale, entail deliberate releases of GM organisms. Thus, the biobased economy brings back a familiar question; is it ethically justifiable, and acceptable to citizens, to expose the environment and society to the risks associated with GM, in order to protect that same environment and to sustain our affluent way of life? For a successful innovation towards a biobased economy, its proponents, especially producers, need to take into account (take responsibility for) such issues when developing new products and processes. These issues, and how scientists can interact with citizens about them in a timely way, are further explored in projects at Delft University and Leiden University, also in collaboration with Utrecht University. PMID: 17061382 [PubMed - indexed for MEDLINE] 17: J Agric Environ Ethics. 2006;19(3):225-38. The moral difference between intragenic and transgenic modification of plants. Myskja BK. Department of Philosophy, NTNU Trondheim, NO-7491 Trondheim, Norway. bjorn.myskja@hf.ntnu.no Public policy on the development and use of genetically modified organisms (GMOs) has mainly been concerned with defining proper strategies of risk management. However, surveys and focus group interviews show that although lay people are concerned with risks, they also emphasize that genetic modification is ethically questionable in itself. Many people feel that this technology "tampers with nature" in an unacceptable manner. This is often identified as an objection to the crossing of species borders in producing transgenic organisms. Most scientists reject these opinions as based on insufficient knowledge about biotechnology, the concept of species, and nature in general. Some recent projects of genetic modification aim to accommodate the above mentioned concerns by altering the expression of endogenous genes rather than introducing genes from other species. There can be good scientific reasons for this approach, in addition to strategic reasons related to greater public acceptability. But are there also moral reasons for choosing intragenic rather than transgenic modification? I suggest three interrelated moral reasons for giving priority to intragenic modification. First, we should respect the opinions of lay people even when their view is contrary to scientific consensus; they express an alternative world-view, not scientific ignorance. Second, staying within species borders by strengthening endogenous traits reduces the risks and scientific uncertainty. Third, we should show respect for nature as a complex system of laws and interconnections that we cannot fully control. The main moral reason for intragenic modification, in our view, is the need to respect the "otherness" of nature. PMID: 17061380 [PubMed - indexed for MEDLINE] 18: Dev Biol (Basel). 2006;126:79-86; discussion 324-5. In-house validation and quality control of real-time PCR methods for GMO detection: a practical approach. Ciabatti I, Froiio A, Gatto F, Amaddeo D, Marchesi U. Istituto Zooprofilattico Sperimentale Lazio e Toscana, National Reference Center for GMO Analysis, Rome, Italy. iciabatti@rm.izs.it GMO detection and quantification methods in the EU are mainly based on real-time PCR. The analytical methods in use must be validated, first on an intra-laboratory scale and through a collaborative trial thereafter. Since a consensual protocol for intra-laboratory validation of real-time PCR methods is lacking, we provide a practical approach for the in-house validation of quantitative real-time PCR methods, establishing acceptability criteria and quality controls for PCR runs. Parameters such as limit of detection, limit of quantification, precision, trueness, linear dynamic range, PCR efficiency, robustness and specificity are considered. The protocol is sufficiently detailed to be directly applicable, increases the reliability of results and their harmonization among different laboratories, and represents a necessary preliminary step before proceeding to a time-consuming and costly full validation study. PMID: 17058483 [PubMed - indexed for MEDLINE] 19: Nat Biotechnol. 2006 Oct;24(10):1178. Parallel universes? [No authors listed] An EU Commissioner has a meeting of minds with an antibiotech agitator. Publication Types: Editorial PMID: 17033639 [PubMed - indexed for MEDLINE] 20: Nat Biotechnol. 2006 Oct;24(10):1177. Why silence is not an option. [No authors listed] GM products will continue to be marginalized in Europe as long as industry remains silent. Publication Types: Editorial PMID: 17033637 [PubMed - indexed for MEDLINE]