1: Bull Acad Natl Med. 2007 Apr-May;191(4-5):807-14; discussion 814. [Allergic risk and role of the Allergy Vigilance Network] [Article in French] Moneret-Vautrin DA. Medecine interne, immunologie clinique et allergologique, Hopital Central, 54035 Nancy cedex. The recent increase in the incidence of severe anaphylaxis calls for continual assessment of risk factor and dangers associated with food allergy, keeping abreast of changes in the food industry. Allergologists, regulatory bodies and the food industry are all responsible for food safety. The Allergy Vigilance Network, founded by a university research team and comprising 398 French and Belgian allergologists, has developed a three-point strategy. First, reporting cases of severe anaphylaxis of document allergic origin makes it possible to monitor the prevalence of food allergens and to evaluate the quality of management of allergy-related emergencies, thus providing data suitable for estimating the economic burden of anaphylaxis. The second objective of the network is to set up multicenter trials to determine the prevalence of sensitization to risk allergens, such as peanut, lupin and plant pollen, of which transgenic varieties will soon emerge. The third objective is screening and long-term monitoring of dangers related to new foods, ingredients and adjuvant sensitizing factors. Post-marketing monitoring of potential allergic risks arising from genetically modified food is another aim of the network, together with the establishment of a serum bank, following WHO/FAO recommendations. The Allergy Vigilance Network, together with the French National Institute for Food Safety (AFSSA), the Ministry of Consumer Affairs (DGCCRF) and various patient associations, is striving to analyse and deal with dangers related to the allergenicity of natural and modified food proteins. Publication Types: Comparative Study English Abstract PMID: 18225435 [PubMed - indexed for MEDLINE] 2: Nat Biotechnol. 2008 Jan;26(1):73-81. Allergenicity assessment of genetically modified crops--what makes sense? Goodman RE, Vieths S, Sampson HA, Hill D, Ebisawa M, Taylor SL, van Ree R. Department of Food Science & Technology, University of Nebraska, Lincoln, Nebraska, 68583-0955, USA. rgoodman2@unlnotes.unl.edu GM crops have great potential to improve food quality, increase harvest yields and decrease dependency on certain chemical pesticides. Before entering the market their safety needs to be scrutinized. This includes a detailed analysis of allergenic risks, as the safety of allergic consumers has high priority. However, not all tests currently being applied to assessing allergenicity have a sound scientific basis. Recent events with transgenic crops reveal the fallacy of applying such tests to GM crops. Publication Types: Research Support, U.S. Gov't, Non-P.H.S. Review PMID: 18183024 [PubMed - indexed for MEDLINE] 3: Nature. 2007 Dec 13;450(7172):928-9. Showdown for Europe. Abbott A, Schiermeier Q. Publication Types: News PMID: 18075535 [PubMed - indexed for MEDLINE] 4: Nature. 2007 Dec 13;450(7172):921. Directive action required. [No authors listed] Publication Types: Editorial PMID: 18075528 [PubMed - indexed for MEDLINE] 5: Nat Biotechnol. 2007 Dec;25(12):1356; author reply 1359-60. Comment on: Nat Biotechnol. 2007 Sep;25(9):981-7. GM soybeans--revisiting a controversial format. Cummins J. Publication Types: Comment Letter PMID: 18066023 [PubMed - indexed for MEDLINE] 6: Nat Biotechnol. 2007 Dec;25(12):1356-8. Comment on: Nat Biotechnol. 2007 Sep;25(9):981-7. Response to GM soybeans-revisiting a controversial format. [No authors listed] Publication Types: Comment PMID: 18066022 [PubMed - indexed for MEDLINE] 7: Nat Biotechnol. 2007 Dec;25(12):1355; author reply 1359-60. Comment on: Nat Biotechnol. 2007 Sep;25(9):981-7. GM soybeans--revisiting a controversial format. Ho MW, Saunders PT. Publication Types: Comment Letter PMID: 18066021 [PubMed - indexed for MEDLINE] 8: Nat Biotechnol. 2007 Dec;25(12):1355; author reply 1359-60. Comment on: Nat Biotechnol. 2007 Sep;25(9):981-7. GM soybeans--revisiting a controversial format. Leifert C. Publication Types: Comment Letter PMID: 18066020 [PubMed - indexed for MEDLINE] 9: Nat Biotechnol. 2007 Dec;25(12):1355-6; author reply 1359-60. Comment on: Nat Biotechnol. 2007 Sep;25(9):981-7. GM soybeans--revisiting a controversial format. Heinemann JA, Traavik T. Publication Types: Comment Letter PMID: 18066019 [PubMed - indexed for MEDLINE] 10: Nat Biotechnol. 2007 Dec;25(12):1354-5; author reply 1359-60. Comment on: Nat Biotechnol. 2007 Sep;25(9):981-7. GM soybeans--revisiting a controversial format. John B. Publication Types: Comment Letter PMID: 18066018 [PubMed - indexed for MEDLINE] 11: Nat Biotechnol. 2007 Dec;25(12):1351-4; author reply 1359-60. Comment on: Nat Biotechnol. 2007 Sep;25(9):981-7. GM soybeans--revisiting a controversial format. Ermakova IV. Publication Types: Comment Letter PMID: 18066017 [PubMed - indexed for MEDLINE] 12: Nat Biotechnol. 2007 Dec;25(12):1330. Another inconvenient truth. In Europe, no one apparently wants to listen if you have good news about genetically modified organisms (GMOs). [No authors listed] Publication Types: Editorial PMID: 18066008 [PubMed - indexed for MEDLINE] 13: Toxicol Sci. 2008 Mar;102(1):100-9. Epub 2007 Nov 21. Differences in Allergenic Potential of Food Extracts following Oral Exposure in Mice Reflect Differences in Digestibility: Potential Approaches to Safety Assessment. Bowman CC, Selgrade MK. Immunotoxicology Branch, Experimental Toxicology Division, National Health and Environmental Effects Research Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711. An animal model for food allergy is needed to assess genetically modified food crops for potential allergenicity. The ideal model must produce allergic antibody (IgE) to proteins differentially according to known allergenicity before being used to accurately identify potential allergens among novel proteins. The oral route is the most relevant for exposure to food antigens, and a protein's stability to digestion is a current risk assessment tool based on this natural route. However, normal laboratory animals do not mount allergic responses to proteins administered orally due to oral tolerance, an immunologic mechanism which specifically suppresses IgE. To circumvent oral tolerance and evoke differential IgE responses to a panel of allergenic and nonallergenic food extracts, female C3H/HeJ mice were exposed subcutaneously or orally with cholera toxin as an adjuvant. All foods elicited IgE by the subcutaneous route. Oral exposure, however, resulted in IgE to allergens (peanut, Brazil nut, and egg white) but not to nonallergens (spinach and turkey), provided that the dose and exposures were limited. Additionally, in vitro digestibility assays demonstrated the presence of digestion-stable proteins in the allergenic food extracts but not in the nonallergenic foods. Our results suggest that the subcutaneous route is inadequate to distinguish allergens from nonallergens, but oral exposure under the appropriate experimental conditions will result in differential allergic responses in accordance with known allergenicity. Moreover, those foods containing digestion-resistant proteins provoke allergic responses in this model, supporting the current use of pepsin resistance in the decision tree for potential allergenicity assessment. PMID: 18033772 [PubMed - in process] 14: Toxicol Lett. 2007 Dec 10;175(1-3):118-35. Epub 2007 Oct 10. Zero tolerances in food and animal feed -- are there any scientific alternatives? A European point of view on an international controversy. Heberer T, Lahrssen-Wiederholt M, Schafft H, Abraham K, Pzyrembel H, Henning KJ, Schauzu M, Braeunig J, Goetz M, Niemann L, Gundert-Remy U, Luch A, Appel B, Banasiak U, Bol GF, Lampen A, Wittkowski R, Hensel A. Federal Institute for Risk Assessment, Section 55, - Residues of Medicinal Products, Diedersdorfer Weg 1, 12277 Berlin, Germany. bfr@bfr.bund.de A number of zero tolerance provisions are contained in both food and animal feed law, e.g. for chemical substances whose occurrence is not permitted or is directly prohibited in food or animal feed. In the European Union, bans of this kind were introduced to give consumers and animals the greatest possible protection from substances with a possible hazard potential within the intendment of the hazard prevention principles and current precautionary measures. This also applies to substances for which an acceptable daily intake cannot be derived and a maximum residue limit cannot, therefore, be established, e.g. due to missing or inadequate toxicological data. Zero tolerances are also under discussion as trade barriers because their use has triggered numerous legal disputes. This paper draws together the results of an evaluation of alternative risk assessment methods to be used for the risk assessment of substances to which currently only zero tolerances apply. It will demonstrate that, depending on the available toxicological data, a scientifically sound risk assessment may still be possible. In this context, the two concepts - margin of exposure and threshold of toxicological concern - are very promising approaches. Until the scientific and sociopolitical discussions have been completed, it is essential that the principle of zero tolerances be upheld, especially for those substances which may be genotoxic carcinogens. In microbiology, there is no legal room for manoeuvre with regard to food safety criteria established for reasons of consumer health protection on the basis of scientific assessments. PMID: 18024010 [PubMed - indexed for MEDLINE] 15: Anal Bioanal Chem. 2008 Jan;390(1):377-87. Epub 2007 Nov 11. Detection and characterization of recombinant DNA expressing vip3A-type insecticidal gene in GMOs--standard single, multiplex and construct-specific PCR assays. Singh CK, Ojha A, Bhatanagar RK, Kachru DN. Industrial Toxicology Research Centre, Post Box No. 80, M. G. Marg, Lucknow, 226001, Uttar Pradesh, India. Vegetative insecticidal protein (Vip), a unique class of insecticidal protein, is now part of transgenic plants for conferring resistance against lepidopteron pests. In order to address the imminent regulatory need for detection and labeling of vip3A carrying genetically modified (GM) products, we have developed a standard single PCR and a multiplex PCR assay. As far as we are aware, this is the first report on PCR-based detection of a vip3A-type gene (vip-s) in transgenic cotton and tobacco. Our assay involves amplification of a 284-bp region of the vip-s gene. This assay can possibly detect as many as 20 natural wild-type isolates bearing a vip3A-like gene and two synthetic genes of vip3A in transgenic plants. The limit of detection as established by our assay for GM trait (vip-s) is 0.1%. Spiking with nontarget DNA originating from diverse plant sources had no inhibitory effect on vip-s detection. Since autoclaving of vip-s bearing GM leaf samples showed no deterioration/interference in detection efficacy, the assay seems to be suitable for processed food products as well. The vip-s amplicon identity was reconfirmed by restriction endonuclease assay. The primer set for vip-s was equally effective in a multiplex PCR assay format (duplex, triplex and quadruplex), used in conjunction with the primer sets for the npt-II selectable marker gene, Cauliflower mosaic virus 35S promoter and nopaline synthetase terminator, enabling concurrent detection of the transgene, regulatory sequences and marker gene. Further, the entire transgene construct was amplified using the forward primer of the promoter and the reverse primer of the terminator. The resultant amplicon served as a template for nested PCR to confirm the construct integrity. The method is suitable for screening any vip3A-carrying GM plant and food. The availability of a reliable PCR assay method prior to commercial release of vip3A-based transgenic crops and food would facilitate rapid and efficient regulatory compliance. Publication Types: Research Support, Non-U.S. Gov't PMID: 17994293 [PubMed - indexed for MEDLINE] 16: Mol Cells. 2007 Oct 31;24(2):301-6. Overexpression of Arabidopsis homogentisate phytyltransferase or tocopherol cyclase elevates vitamin E content by increasing gamma-tocopherol level in lettuce (Lactuca sativa L.). Lee K, Lee SM, Park SR, Jung J, Moon JK, Cheong JJ, Kim M. School of Agricultural Biotechnology and Center for Agricultural Biomaterials, Seoul National University, Seoul 151-921, Korea. Tocopherols, essential components of the human diet, are synthesized exclusively by photosynthetic organisms. To increase tocopherol content by increasing total flux to the tocopherol biosynthetic pathway, genes encoding Arabidopsis homogentisate phytyltransferase (HPT/V-TE2) and tocopherol cyclase (TC/VTE1) were constitutively overexpressed in lettuce (Lactuca sativa L.). Total tocopherol content of the transgenic plants overexpressing either of the genes was increased by more than 2-fold mainly due to an increase in gamma-tocopherol. However, chlorophyll content in the HPT/VTE2 and TC/VTE1 transgenic lines decreased by up to 20% and increased by up to 35%, respectively (P < 0.01). These results demonstrate that manipulation of the tocopherol biosynthetic pathway can increase or decrease chlorophyll content depending on the gene introduced. Publication Types: Research Support, Non-U.S. Gov't PMID: 17978586 [PubMed - indexed for MEDLINE] 17: Ecol Appl. 2007 Oct;17(7):2123-35. Effect of pollinator abundance on self-fertilization and gene flow: application to GM Canola. Hoyle M, Hayter K, Cresswell JE. PenTAG, Peninsula Medical School, University of Plymouth, Noy Scott House, Barrack Road, Exeter EX2 5DW, United Kingdom. m.w.hoyle@exeter.ac.uk Cross-pollination from fields of transgenic crops is of great public concern. Although cross-pollination in commercial canola (Brassica napus) fields has been empirically measured, field trials are expensive and do not identify the causes of cross-pollination. Therefore, theoretical models can be valuable because they can provide estimates of cross-pollination at any given site and time. We present a general analytical model of field-to-field gene flow due to the following competing mechanisms: the wind, bees, and autonomous pollination. We parameterize the model for the particular case of field-to-field cross-pollination of genetically modified (GM) canola via the wind and via bumble bees (Bombus spp.) and honey bees (Apis mellifera). We make extensive use of the large data set of bee densities collected during the recent U.K. Farm Scale Evaluations. We predict that canola approaches almost full seed set without pollinators and that autonomous pollination is responsible for > or = 25% of seed set, irrespective of pollinator abundance. We do not predict the relative contribution of bees vs. the wind in landscape-scale gene flow in canola. However, under model assumptions, we predict that the maximum field-to-field gene flow due to bumble bees is 0.04% and 0.13% below the current EU limit for adventitious GM presence for winter- and spring-sown canola, respectively. We predict that gene flow due to bees is approximately 3.1 times higher at 20% compared to 100% male-fertility, and due to the wind, 1.3 times higher at 20% compared to 100% male-fertility, for both winter- and spring-sown canola. Bumble bee-mediated gene flow is approximately 2.7 times higher and wind-mediated gene flow approximately 1.7 times lower in spring-sown than in winter-sown canola, regardless of the degree of male-sterility. The model of cross-pollination due to the wind most closely predicted three previously published observations: field-to-field gene flow is low; gene flow increases with the proportion of plants that are male-sterile; and gene flow is higher in winter- than in spring-sown canola. Our results therefore suggest that the wind, not bees, is the main vector of long-distance gene flow in canola. Publication Types: Research Support, Non-U.S. Gov't PMID: 17974346 [PubMed - indexed for MEDLINE] 18: Int J Toxicol. 2007 Sep-Oct;26(5):389-99. Strategies to evaluate the safety of bioengineered foods. Delaney B. Pioneer Hi-Bred International, Inc., DuPont Agriculture and Nutrition, Johnston, Iowa 50131-0550, USA. bryan.delaney@pioneer.com A number of genetically modified (GM) crops bioengineered to express agronomic traits including herbicide resistance and insect tolerance have been commercialized. Safety studies conducted for the whole grains and food and feed fractions obtained from GM crops (i.e., bioengineered foods) bear similarities to and distinctive differences from those applied to substances intentionally added to foods (e.g., food ingredients). Similarities are apparent in common animal models, route of exposure, duration, and response variables typically assessed in toxicology studies. However, because of differences in the nutritional and physical properties of food ingredients and bioengineered foods and in the fundamental goals of the overall safety assessment strategies for these different classes of substances, there are recognizable differences in the individual components of the safety assessment process. The fundamental strategic difference is that the process for food ingredients is structured toward quantitative risk assessment whereas that for bioengineered foods is structured for the purpose of qualitative risk assessment. The strategy for safety assessment of bioengineered foods focuses on evaluating the safety of the transgenic proteins used to impart the desired trait or traits and to demonstrate compositional similarity between the grains of GM and non-GM comparator crops using analytical chemistry and, in some cases, feeding studies. Despite these differences, the similarities in the design of safety studies conducted with bioengineered foods should be recognized by toxicologists. The current paper reviews the basic principles of safety assessment for bioengineered foods and compares them with the testing strategies applied to typical food ingredients. From this comparison it can be seen that the strategies used to assess the safety of bioengineered foods are at least as robust as that used to assess the safety of typical food ingredients. Publication Types: Review PMID: 17963126 [PubMed - indexed for MEDLINE] 19: Risk Anal. 2007 Aug;27(4):935-46. An empirical test of competing theories of hazard-related trust: the case of GM food. Allum N. Department of Sociology, University of Surrey, Guildford, UK. n.allum@surrey.ac.uk Few scholars doubt the importance of trust in explaining variation in public perception of technological risk. Relatively little, however, is known about the particular types of judgments that people use in granting or withholding trust. This article presents findings from an empirical study that explores several dimensions of trust relevant for citizens' judgments of scientists involved in the development of GM food. The relationship between particular dimensions of trust and perceptions of GM food risk is also explored, using structural equation modeling. Results suggest that trust judgments based on the perception of shared values are most important in relation to GM food risk, but that judgments about scientists' technical competence are also important. PMID: 17958502 [PubMed - indexed for MEDLINE] 20: J AOAC Int. 2007 Sep-Oct;90(5):1513-6. Development of agricultural biotechnology and biosafety regulations used to assess the safety of genetically modified crops in Iran. Mousavi A, Malboobi MA, Esmailzadeh NS. National Institute of Genetic Engineering and Biotechnology, P.O. Box 14155-6343, Tehran, 1417863171, Iran. m-amir@nrcgeb.ac.ir Rapid progress in the application of biotechnological methodologies and development of genetically modified crops in Iran necessitated intensive efforts to establish proper organizations and prepare required rules and regulations at the national level to ensure safe application of biotechnology in all pertinent aspects. Practically, preparation of a national biotechnology strategic plan in the country coincided with development of a national biosafety framework that was the basis for the drafted biosafety law. Although biosafety measures were observed by researchers voluntarily, the establishment of national biosafety organizations since the year 2000 built a great capacity to deal with biosafety issues in the present and future time, particularly with respect to food and agricultural biotechnology. Publication Types: Review PMID: 17956001 [PubMed - indexed for MEDLINE] 21: J AOAC Int. 2007 Sep-Oct;90(5):1500-7. Development of agriculture biotechnology in Pakistan. Zafar Y. Pakistan Atomic Energy Commission, Agriculture and Biotechnology Division, PO Box No. 1114, Islamabad, Pakistan. y_zafar@yahoo.com Agriculture plays an important role in the national economy of Pakistan, where most of the rapidly increasing population resides in rural areas and depends on agriculture for subsistence. Biotechnology has considerable potential for promoting the efficiency of crop improvement, food production, and poverty reduction. Use of modern biotechnology started in Pakistan since 1985. Currently, there are 29 biotech centers/institutes in the country. However, few centers have appropriate physical facilities and trained manpower to develop genetically modified (GM) crops. Most of the activities have been on rice and cotton, which are among the top 5 crops of Pakistan. Biotic (virus/bacterial/insect) and abiotic (salt) resistant and quality (male sterility) genes have already been incorporated in some crop plants. Despite acquiring capacity to produce transgenic plants, no GM crops, either produced locally or imported, have been released in the country. Pakistan is signatory to the World Trade Organization, Convention on Biological Diversity, and Cartagena protocols. Several legislations under the Agreement on Trade-Related Aspects of Intellectual Property Rights have been promulgated in the country. National Biosafety Guidelines have been promulgated in April 2005. The Plant Breeders Rights Act, Amendment in Seed Act-1976, and Geographical Indication for Goods are still passing through discussion, evaluation, and analysis phases. Meanwhile, an illegal GM crop (cotton) has already sneaked into farmer's field. Concerted and coordinated efforts are needed among various ministries for implementation of regulation and capacity building for import/export and local handling of GM crops. Pakistan could easily benefit from the experience of Asian countries, especially China and India, where conditions are similar and the agriculture sector is almost like that of Pakistan. Thus, the exchange of information and experiences is important among these nations. PMID: 17955999 [PubMed - indexed for MEDLINE] 22: J AOAC Int. 2007 Sep-Oct;90(5):1492-9. Application of current allergy assessment guidelines to next-generation biotechnology-derived crops. Bannon GA, Martino-Catt S. Monsanto Co., Global Regulatory Sciences, 800 N. Lindbergh Blvd, St. Louis, MO 63167, USA. gary.a.bannan@monsanto.com In any single day, our immune systems are exposed to thousands of different proteins from the environment and the food we eat. In a portion of the human population, some of those proteins will stimulate the immune systems to synthesize immunoglobulin E in an allergenic response. The discrepancy between the vast numbers of proteins we encounter and the limited number of proteins that actually become allergens have led scientists on a quest to discover what unique features exist that make proteins destined to be allergens. The information gained from these studies has led to an allergy assessment strategy that characterizes the potential allergenicity of biotechnology products prior to their commercialization. This testing strategy appears to be effective as shown by the fact that there have been no clinically documented food allergic reactions to any of the biotechnology proteins introduced into food crops, to date. The next generation of biotechnology products will most likely contain more complex traits, including nutritionally enhanced food crops, and the question arises as to whether the current allergy assessment strategy will be sufficient to protect the health of the consuming public. In this paper, we discuss general allergen characteristics in order to better understand how proteins become allergens, summarize the current allergy assessment process, evaluate the different aspects of this process for their adequacy in determining the allergenic potential of engineered functional foods, and, finally, we assess the possibility of new technologies having a positive impact on the allergy assessment of nutritionally enhanced crops. Publication Types: Review PMID: 17955998 [PubMed - indexed for MEDLINE] 23: J AOAC Int. 2007 Sep-Oct;90(5):1480-91. An overview of methods for assessment of iron bioavailability from foods nutritionally enhanced through biotechnology. Cockell KA. Health Canada, Nutrition Research Division, Food Directorate, 2203C Banting Research Centre, 251 Sir Frederick Banting Driveway, Ottawa, ON, Canada. kevin_cockell@hc-sc.gc.ca Iron deficiency and iron deficiency anemia continue to be significant public health problems worldwide. While supplementation and fortification have been viable means to improve iron nutriture of the population in developed countries, they may be less successful in developing regions for a number of reasons, including complexities in distribution and consumer compliance. Biofortification of staple crops, through conventional plant breeding strategies or modern methods of biotechnology, provides an alternative approach that may be more sustainable once initial investments have been made. Three types of biofortification strategies are being essayed, singly or in combination: increasing the total iron content of edible portions of the plant, decreasing the levels of inhibitors of iron absorption, and increasing the levels of factors that enhance iron absorption. Bioavailability is a key concept in iron nutrition, particularly for nonheme iron such as is found in these biofortified foods. An overview is presented of methods for evaluation of iron bioavailability from foods nutritionally enhanced through biotechnology. PMID: 17955997 [PubMed - indexed for MEDLINE] 24: J AOAC Int. 2007 Sep-Oct;90(5):1470-9. Nutritional and safety assessments of foods and feeds nutritionally improved through biotechnology: lysine maize as a case study. Glenn KC. Monsanto Co., 800 North Lindbergh Blvd, E3NB, St. Louis, MO 63167, USA. kevin.c.glenn@monsanto.com During the last decade, the area of biotech crops modified for agronomic input traits (e.g., herbicide tolerance and insect protection) has increased to 90 million halyear, grown by over 8 million farmers in a total of 17 countries. As adoption of these improved agronomic trait biotech crops has grown, so has interest in biotech crops that have improved nutritional characteristics for use as feed and food. A previous publication by the International Life Sciences Institute (ILSI) reported on the principles and concepts proposed for the nutritional and safety assessments of foods and feeds nutritionally improved through biotechnology. In this paper, the guidelines and principles recommended in the earlier publication are discussed relative to a specific case study, Lysine maize. Lysine maize is a feed ingredient with enhanced nutritional characteristics for poultry and swine and provides an alternative to the need for addition of supplemental lysine to some diets for these animals. The 2004 Task Force of the ILSI has also applied the concepts from that report to 4 other case studies: sweet potato enriched in provitamin A (2 examples, one using biotechnology and one using conventional breeding); Golden Rice 2; double-embryo maize; and ASP-1 enhanced protein sweet potato. PMID: 17955996 [PubMed - indexed for MEDLINE] 25: Appl Environ Microbiol. 2007 Dec;73(24):8012-7. Epub 2007 Oct 12. Effect of feeding cows genetically modified maize on the bacterial community in the bovine rumen. Wiedemann S, Gurtler P, Albrecht C. Institute of Biochemistry and Molecular Medicine, University of Bern, Buehlstr. 28, CH-3012 Bern, Switzerland. christiane.albrecht@mci.unibe.ch Rumen-cannulated cows (n = 4) were fed successively silage made from either conventional or genetically modified (GM) maize. Results revealed no effects of GM maize on the dynamics of six ruminal bacterial strains (investigated by real-time PCR) compared to the conventional maize silage. Publication Types: Comparative Study Research Support, Non-U.S. Gov't PMID: 17933942 [PubMed - indexed for MEDLINE] 26: Vet Res Commun. 2007 Aug;31 Suppl 1:385-8. Detection of genetically modified organisms in food: comparison among three different DNA extraction methods. Vodret B, Milia M, Orani MG, Serratrice G, Mancuso MR. Zooprofilattic Institute of Sardinia, Feed Hygiene Unit, Sassari, Italy. bruna.vodret@izs-sardegna.it PMID: 17682920 [PubMed - indexed for MEDLINE] 27: Nat Biotechnol. 2007 Oct;25(10):1065-6. Europe's anti-GM stance to presage animal feed shortage? Mitchell P. Publication Types: News PMID: 17921975 [PubMed - indexed for MEDLINE] 28: Food Chem Toxicol. 2007 Nov;45(11):2073-85. Epub 2007 Aug 30. Report of an Expert Panel on the reanalysis by of a 90-day study conducted by Monsanto in support of the safety of a genetically modified corn variety (MON 863). Doull J, Gaylor D, Greim HA, Lovell DP, Lynch B, Munro IC. Pharmacology, Toxicology and Therapeutics, Division of Toxicology, Department of Pharmacology, The University of Kansas Medical Center, 1018A Briedenthal Building, 3901 Rainbow Boulevard, Kansas City, KS 66160-7417, USA. MON 863, a genetically engineered corn variety that contains the gene for modified Bacillus thuringiensis Cry3Bb1 protein to protect against corn rootworm, was tested in a 90-day toxicity study as part of the process to gain regulatory approval. This study was reanalyzed by Seralini et al. who contended that the study showed possible hepatorenal effects of MON 863. An Expert Panel was convened to assess the original study results as analyzed by the Monsanto Company and the reanalysis conducted by Seralini et al. The Expert Panel concludes that the Seralini et al. reanalysis provided no evidence to indicate that MON 863 was associated with adverse effects in the 90-day rat study. In each case, statistical findings reported by both Monsanto and Seralini et al. were considered to be unrelated to treatment or of no biological or clinical importance because they failed to demonstrate a dose-response relationship, reproducibility over time, association with other relevant changes (e.g., histopathology), occurrence in both sexes, difference outside the normal range of variation, or biological plausibility with respect to cause-and-effect. The Seralini et al. reanalysis does not advance any new scientific data to indicate that MON 863 caused adverse effects in the 90-day rat study. Publication Types: Research Support, Non-U.S. Gov't Review PMID: 17900781 [PubMed - indexed for MEDLINE] 29: Nat Biotechnol. 2007 Sep;25(9):981-7. Comment in: Nat Biotechnol. 2007 Dec;25(12):1351-4; author reply 1359-60. Nat Biotechnol. 2007 Dec;25(12):1354-5; author reply 1359-60. Nat Biotechnol. 2007 Dec;25(12):1355-6; author reply 1359-60. Nat Biotechnol. 2007 Dec;25(12):1355; author reply 1359-60. Nat Biotechnol. 2007 Dec;25(12):1355; author reply 1359-60. Nat Biotechnol. 2007 Dec;25(12):1356-8. Nat Biotechnol. 2007 Dec;25(12):1356; author reply 1359-60. GM soybeans and health safety--a controversy reexamined. Marshall A. PMID: 17846624 [PubMed - indexed for MEDLINE] 30: Nature. 2007 Sep 6;449(7158):9. Biotech crop rules get rewrite. Marris E. Publication Types: News PMID: 17805261 [PubMed - indexed for MEDLINE] 31: Ir Med J. 2007 May;100(5):475-6. Genetically modified food and health--a cause for concern? Cullen E. Publication Types: Letter PMID: 17727126 [PubMed - indexed for MEDLINE] 32: Regul Toxicol Pharmacol. 2007 Oct;49(1):53-62. Comparative safety testing of genetically modified foods in a 90-day rat feeding study design allowing the distinction between primary and secondary effects of the new genetic event. Knudsen I, Poulsen M. Department of Toxicology and Risk Assessment, National Food Institute, Technical University of Denmark, 19 Moerkhoej Bygade, DK-2860 Soeborg, Denmark. This article discusses the wider experiences regarding the usefulness of the 90-day rat feeding study for the testing of whole foods from genetically modified (GM) plant based on data from a recent EU-project [Poulsen, M., Schroder, M., Wilcks, A., Kroghsbo, S., Lindecrona, R.H., Miller, A., Frenzel, T., Danier, J., Rychlik, M., Shu, Q., Emami, K., Taylor, M., Gatehouse, A., Engel, K.-H., Knudsen, I., 2007a. Safety testing of GM-rice expressing PHA-E lectin using a new animal test design. Food Chem. Toxicol. 45, 364-377; Poulsen, M., Kroghsbo, S., Schroder, M., Wilcks, A., Jacobsen, H., Miller, A., Frenzel, T., Danier, J., Rychlik, M., Shu, Q., Emami, K., Sudhakar, D., Gatehouse, A., Engel, K.-H., Knudsen, I., 2007b. A 90-day safety in Wistar rats fed genetically modified rice expressing snowdrop lectin Galanthus nivalis (GNA). Food Chem. Toxicol. 45, 350-363; Schroder, M., Poulsen, M., Wilcks, A., Kroghsbo, S., Miller, A., Frenzel, T., Danier, J., Rychlik, M., Emami, K., Gatehouse, A., Shu, Q., Engel, K.-H., Knudsen, I., 2007. A 90-day safety study of genetically modified rice expressing Cry1Ab protein (Bacillus thuringiensis toxin) in Wistar rats. Food Chem. Toxicol. 45, 339-349]. The overall objective of the project has been to develop and validate the scientific methodology necessary for assessing the safety of foods from genetically modified plants in accordance with the present EU regulation. The safety assessment in the project is combining the results of the 90-day rat feeding study on the GM food with and without spiking with the pure novel gene product, with the knowledge about the identity of the genetic change, the compositional data of the GM food, the results from in-vitro/ex-vivo studies as well as the results from the preceding 28-day toxicity study with the novel gene product, before the hazard characterisation is concluded. The results demonstrated the ability of the 90-day rat feeding study to detect the biological/toxicological effects of the new gene product in the GM food. The authors consider on this basis that the 90-day, rodent feeding study with one high dose level and a dietary design based upon compositional data on the GM food and toxicity data on the gene product is sensitive and specific enough to verify the presence/absence of the biological/nutritional/toxicological effects of the novel gene insert and further by the use of spiking able to separate potentially unintended effects of the novel gene product from other unintended effects at the level of intake defined in the test and within the remit of the test. Recommendations for further work necessary in the field are given. Publication Types: Comparative Study Research Support, Non-U.S. Gov't PMID: 17719159 [PubMed - indexed for MEDLINE] 33: Sci Eng Ethics. 2007 Mar;13(1):69-82. A case for a duty to feed the hungry: GM plants and the third world. Carter L. The School of History, Philosophy, Religion and Classics, The University of Queensland, Brisbane, Australia. l.carter@uq.edu.au This article is concerned with a discussion of the plausibility of the claim that GM technology has the potential to provide the hungry with sufficient food for subsistence. Following a brief outline of the potential applications of GM in this context, a history of the green revolution and its impact will be discussed in relation to the current developing world agriculture situation. Following a contemporary analysis of malnutrition, the claim that GM technology has the potential to provide the hungry with sufficient nourishment will be discussed within the domain of moral philosophy to determine whether there exists a moral obligation to pursue this end if and only if the technology proves to be relatively safe and effective. By using Peter Singer's duty of moral rescue, I argue that we have a moral duty to assist the third world through the distribution of such GM plants. I conclude the paper by demonstrating that my argument can be supported by applying a version of the Precautionary Principle on the grounds that doing nothing might be worse for the current situation. PMID: 17703610 [PubMed - indexed for MEDLINE] 34: Biotechnol J. 2007 Sep;2(9):1086-7. The difficulty of structuring and focusing the co-existence debate in Europe. Custers R. VIB, Gent, Belgium. Rene.Custers@vib.be The co-existence debate in Europe is wide and difficult. In this paper some recommendations are given on how to make progress in the debate. Not with the goal of pushing GMOs, but with the goal of achieving genuine freedom of choice. PMID: 17703493 [PubMed - indexed for MEDLINE] 35: Biotechnol J. 2007 Sep;2(9):1141-6. Transparent communication strategy on GMOs: will it change public opinion? Sinemus K, Egelhofer M. Genius Gmbh, Darmstadt, Germany. Kristina.Sinemus@genius.de Innovations are central for the economic growth; however, the use of new technologies needs to be widely accepted in the general public and the society as a whole. Biotechnology in general, and the use of genetic engineering in food production in particular are seen critically by the European public and perceived as "risky", and a transatlantic divide between European and US citizens has been observed. This review investigates the reasons for those differing perceptions and proposes new strategies to communicate the benefits of biotechnology in agriculture to a broader public. When analyzing the dialogue process that has taken place between public, scientists, governmental organizations and industry, questions arise on what has been done differently in Europe, in order to propose new, more successful and efficient communication strategies for the future. Publication Types: Review PMID: 17703492 [PubMed - indexed for MEDLINE] 36: Biotechnol J. 2007 Sep;2(9):1088-92. Intellectual property, genetically modified crops and bioethics. Adcock M. Department of Law, Durham University, Durham, UK. mike.adcock@durham.ac.uk The implementation of a new technology is almost always surrounded by a debate on the moral and social implications that may arise. The debate with regard to genetically modified (GM) crops has been one of the longest and most controversial. However, one area of the debate that receives less attention is the role that intellectual property can play. The introduction of an effective and yet appropriate intellectual property system addressing society's particular needs can eliminate some of these issues. This paper looks at whether the situation in Europe is meeting our current needs and also addresses the role intellectual property can play in the debate over the introduction of GM crops in developing countries. Publication Types: Review PMID: 17703487 [PubMed - indexed for MEDLINE] 37: Transgenic Res. 2007 Dec;16(6):675-88. Epub 2007 Aug 14. Genetically modified crops for the bioeconomy: meeting public and regulatory expectations. Chapotin SM, Wolt JD. US Agency for International Development, Washington, DC 20523, USA. As the United States moves toward a plant-based bioeconomy, a large research and development effort is focused on creating new feedstocks to meet biomass demand for biofuels, bioenergy, and specialized bioproducts, such as industrial compounds and biomaterial precursors. Most bioeconomy projections assume the widespread deployment of novel feedstocks developed through the use of modern molecular breeding techniques, but rarely consider the challenges involved with the use of genetically modified crops, which can include hurdles due to regulatory approvals, market adoption, and public acceptance. In this paper we consider the implications of various transgenic crops and traits under development for the bioeconomy that highlight these challenges. We believe that an awareness of the issues in crop and trait selection will allow developers to design crops with maximum stakeholder appeal and with the greatest potential for widespread adoption, while avoiding applications unlikely to meet regulatory approval or gain market and public acceptance. Publication Types: Review PMID: 17701080 [PubMed - indexed for MEDLINE] 38: Nature. 2007 Aug 16;448(7155):736. Geneticist trades plants for politics. Nina Fedoroff interviewed by Emma Marris. Fedoroff N. Publication Types: Interview PMID: 17700665 [PubMed - indexed for MEDLINE] 39: Food Chem Toxicol. 2007 Dec;45(12):2513-25. Epub 2007 Jun 21. History of safe use as applied to the safety assessment of novel foods and foods derived from genetically modified organisms. Constable A, Jonas D, Cockburn A, Davi A, Edwards G, Hepburn P, Herouet-Guicheney C, Knowles M, Moseley B, Oberdorfer R, Samuels F. Nestle Research Centre, Vers-Chez-les-blanc 1000, Lausanne 26, Switzerland. Very few traditional foods that are consumed have been subjected to systematic toxicological and nutritional assessment, yet because of their long history and customary preparation and use and absence of evidence of harm, they are generally regarded as safe to eat. This 'history of safe use' of traditional foods forms the benchmark for the comparative safety assessment of novel foods, and of foods derived from genetically modified organisms. However, the concept is hard to define, since it relates to an existing body of information which describes the safety profile of a food, rather than a precise checklist of criteria. The term should be regarded as a working concept used to assist the safety assessment of a food product. Important factors in establishing a history of safe use include: the period over which the traditional food has been consumed; the way in which it has been prepared and used and at what intake levels; its composition and the results of animal studies and observations from human exposure. This paper is aimed to assist food safety professionals in the safety evaluation and regulation of novel foods and foods derived from genetically modified organisms, by describing the practical application and use of the concept of 'history of safe use'. Publication Types: Research Support, Non-U.S. Gov't PMID: 17692450 [PubMed - indexed for MEDLINE] 40: Duke Law J. 2007 Apr;56(6):1581-6. Beyond food and evil. Chen J. University of Louisville, Louis D. Brandeis School of Law. PMID: 17679180 [PubMed - indexed for MEDLINE] 41: Trends Biotechnol. 2007 Sep;25(9):376-84. Epub 2007 Jul 30. Humanizing infant milk formula to decrease postnatal HIV transmission. Blais DR, Altosaar I. Department of Biochemistry, Microbiology and Immunology, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, K1H 8M5, Canada. There are currently no safe methods for feeding babies born from the 16 million HIV-infected women living in resource-constrained countries. Breast milk can transmit HIV, and formula feeding can lead to gastrointestinal illnesses owing to unsanitary conditions and the composition of milk formulations. There is therefore a need to ensure that breast milk substitutes provide optimal health outcomes. Given that the immune properties of several breast milk proteins are known, transgenic food crops could facilitate inexpensive and safe reconstitution of the beneficial breast milk proteome in infant formulae, while keeping the HIV virus at bay. At least seven breast milk immune proteins have already been produced in food crops, and dozens more proteins could potentially be produced if fortified formula proves effective in nursing newborns born to HIV-infected mothers. Publication Types: Research Support, Non-U.S. Gov't Review PMID: 17659799 [PubMed - indexed for MEDLINE] 42: Shokuhin Eiseigaku Zasshi. 2007 Jun;48(3):41-50. [A 52-week feeding study of genetically modified soybeans in F344 rats] [Article in Japanese] Sakamoto Y, Tada Y, Fukumori N, Tayama K, Ando H, Takahashi H, Kubo Y, Nagasawa A, Yano N, Yuzawa K, Ogata A, Kamimura H. Department of Environmental Health and Toxicology, Tokyo Metropolitan Institute of Public Health: 3-24-1 Hyakunin-cho, Shinjuku-ku, Tokyo 169-0073, Japan. A chronic feeding study to evaluate the safety of the genetically modified glyphosate-tolerant soybeans (GM soybeans) was conducted using rats. F344 DuCrj rats were fed diet containing GM soybeans or Non-GM soybeans at the concentration of 30% in basal diet. Non-GM soybeans were closely related strain of GM soybeans. These two diets were adjusted to an identical nutrient level. In this study, the influence of GM soybeans on rats was compared with that of the Non-GM soybeans, and furthermore, to assess the effect of soybeans themselves, the groups of rats fed GM and Non-GM soybeans were compared with a group fed commercial diet (CE-2). General conditions were observed daily and body weight and food consumption were recorded. At the intermediate examination (26 weeks), and at the termination (52 weeks), animals were subjected to hematology, serum biochemistry, and pathological examination. There were several differences in animal growth, food intake, serum biochemical parameters and histological findings between the rats fed the GM and/or Non-GM soybeans and the rats fed CE-2. However, body weight and food intake were similar for the rats fed the GM and Non-GM soybeans. Gross necropsy findings, hematological and serum biochemical parameters, organ weights, and pathological findings showed no meaningful difference between rats fed the GM and Non-GM soybeans. These results indicate that long-term intake of GM soybeans at the level of 30% in diet has no apparent adverse effect in rats. Publication Types: English Abstract PMID: 17657996 [PubMed - indexed for MEDLINE] 43: Plant Biotechnol J. 2007 Sep;5(5):555-69. Epub 2007 Jul 21. Improving containment strategies in biopharming. Murphy DJ. Biotechnology Unit, Division of Biological Sciences, University of Glamorgan, Treforest, CF37 1DL, UK. dmurphy2@glam.ac.uk This review examines the challenges of segregating biopharmed crops expressing pharmaceutical or veterinary agents from mainstream crops, particularly those destined for food or feed use. The strategy of using major food crops as production vehicles for the expression of pharmaceutical or veterinary agents is critically analysed in the light of several recent episodes of contamination of the human food chain by non-approved crop varieties. Commercially viable strategies to limit or avoid biopharming intrusion into the human food chain require the more rigorous segregation of food and non-food varieties of the same crop species via a range of either physical or biological methods. Even more secure segregation is possible by the use of non-food crops, non-crop plants or in vitro plant cultures as production platforms for biopharming. Such platforms already under development range from outdoor-grown Nicotiana spp. to glasshouse-grown Arabidopsis, lotus and moss. Amongst the more effective methods for biocontainment are the plastid expression of transgenes, inducible and transient expression systems, and physical containment of plants or cell cultures. In the current atmosphere of heightened concerns over food safety and biosecurity, the future of biopharming may be largely determined by the extent to which the sector is able to maintain public confidence via a more considered approach to containment and security of its plant production systems. Publication Types: Review PMID: 17645439 [PubMed - indexed for MEDLINE] 44: Environ Biosafety Res. 2006 Oct-Dec;5(4):237-8. Epub 2007 Jul 20. The Japanese experience with the Blue Book and subsequent activities in environmental biosafety of GM crops. Hayashi K. Society for Techno-Innovation of Agriculture, Forestry and Fisheries, Sankaido Bldg. 7F, 1-9-13 Akasaka, Minato-ku, Tokyo 107-0052, Japan. hayashi@staff.or.jp The Blue Book made a big contribution to the development of the Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF) guidelines established in 1991 for almost all of the basic issues. However, the MAFF guidelines could not sufficiently cover some important areas that the Blue Book addressed well, such as potential consequences. This gap has been recovered substantially by a new law established in 2003. Japan still faces several important issues, including assessment of stacked products, potential consequences, comparative assessment, assessment of imported GM commodities and movement of concerned groups. PMID: 17640516 [PubMed - indexed for MEDLINE] 45: Nat Biotechnol. 2007 Jul;25(7):717-8. The status of GM rice R&D in China. Wang Y, Johnston S. Publication Types: Letter PMID: 17621287 [PubMed - indexed for MEDLINE] 46: Nature. 2007 Jun 28;447(7148):1042. Uganda hosts banana trial. Dauwers A. Publication Types: News PMID: 17597729 [PubMed - indexed for MEDLINE] 47: Br J Soc Psychol. 2007 Jun;46(Pt 2):437-57. Predicting behaviour towards genetically modified food using implicit and explicit attitudes. Spence A, Townsend E. RASPH, School of Psychology, University of Nottingham, UK. spenceAl@cardiff.ac.uk The predictive validity of implicit and explicit attitudes is a central question in social psychological research with important theoretical and empirical ramifications. Three main patterns of combining implicit and explicit attitudes to predict behaviour have been postulated. They are, double dissociation (in which implicit and explicit attitudes predict spontaneous and deliberate behaviour respectively), additive (in which implicit and explicit attitudes both predict variance in behaviour) and interactive (in which implicit and explicit attitudes combine to predict behaviour). These models were tested in this study using a structural equation modelling approach utilising three different measures of behaviour (of varying spontaneity) towards genetically modified (GM) food. The additive pattern, in which implicit and explicit attitudes both predict variance in behaviour, was found to best fit the data. In addition, all behaviour measures indicated that the majority of participants were willing to try GM food in some situations. Publication Types: Research Support, Non-U.S. Gov't PMID: 17565791 [PubMed - indexed for MEDLINE] 48: Nat Biotechnol. 2007 Jun;25(6):624-6. Comment on: Nat Biotechnol. 2006 May;24(5):498; author reply 499. Trends in GM crop, food and feed safety literature. Vain P. Publication Types: Comment Letter PMID: 17557092 [PubMed - indexed for MEDLINE] 49: Food Nutr Bull. 2006 Sep;27(3):265-6. Quality protein maize. Scrimshaw NS. PMID: 17542118 [PubMed - indexed for MEDLINE] 50: Adv Biochem Eng Biotechnol. 2007;107:57-68. Genetically modified organisms in the United States: implementation, concerns, and public perception. Oeschger MP, Silva CE. Department of Microbiology, Immunology and Parasitology, Louisiana State University Health Sciences Center, New Orleans, LA 70112, USA. moesch@lsuhsc.edu We examine the state of biotechnology with respect to genetically modified (GM) organisms in agriculture. Our focus is on the USA, where there has been significant progress and implementation but where, to date, the matter has drawn little attention. GM organisms are the result of lateral gene transfers, the transfer of genes from one species to another, or sometimes, from one kingdom to another. The introduction of foreign genes makes some people very uncomfortable, and a small group of activists have grave concerns about the technology. Attempts by activists to build concern in the general public have garnered little attention; however, the producers of GM organisms have responded to their concerns and established extensive testing programs to be applied to each candidate organism that is produced. In the meantime, GM varieties of corn, cotton, soybean and rapeseed have been put into agricultural production and are now extensively planted. These crops, and the other, newer GM crops, have produced no problems and have pioneered a silent agricultural revolution in the USA. Publication Types: Review PMID: 17522820 [PubMed - indexed for MEDLINE] 51: Adv Biochem Eng Biotechnol. 2007;107:1-11. The gap between science and perception: the case of plant biotechnology in Europe. Einsele A. Internutrition, Postfach, 8035, Zurich, Switzerland. arthur.einsele@internutrition.ch Although the global area of biotech crops continues to climb for the tenth consecutive year at a sustainable double-digit growth rate, the acceptance of biotech products from agriculture in Europe is still low. There is a gap between science and perception. It is a strong belief that the public turning against science and against GM food has been encouraged by the negative activities of NGO groups. Scientists have to overcome the purely risk-based discussion, and the benefits of plant biotechnology have to be made literally visible. GM food should be available, the benefits should be tangible and the consumer should have fun with such novel food. The gap could be reduced if genetically modified plants and the products thereof were regulated in the same way as classical products. Publication Types: Review PMID: 17522817 [PubMed - indexed for MEDLINE] 52: J Agric Food Chem. 2007 Jun 13;55(12):4728-34. Epub 2007 May 18. Development of a certified reference material for genetically modified potato with altered starch composition. Broothaerts W, Corbisier P, Emons H, Emteborg H, Linsinger TP, Trapmann S. European Commission, Joint Research Centre, Institute for Reference Materials and Measurements (IRMM), Retieseweg 111, 2440 Geel, Belgium. Wim.Broothaerts@ec.europa.eu The presence of genetically modified organisms (GMOs) in food and feed products is subject to regulation in the European Union (EU) and elsewhere. As part of the EU authorization procedure for GMOs intended for food and feed use, reference materials must be produced for the quality control of measurements to quantify the GMOs. Certified reference materials (CRMs) are available for a range of herbicide- and insect-resistant genetically modified crops such as corn, soybean, and cotton. Here the development of the first CRM for a GMO that differs from its non-GMO counterpart in a major compositional constituent, that is, starch, is described. It is shown that the modification of the starch composition of potato (Solanum tuberosum L.) tubers, together with other characteristics of the delivered materials, have important consequences for the certification strategy. Moreover, the processing and characterization of the EH92-527-1 potato material required both new and modified procedures, different from those used routinely for CRMs produced from genetically modified seeds. PMID: 17508757 [PubMed - indexed for MEDLINE] 53: J Agric Food Chem. 2007 Jun 13;55(12):4670-7. Epub 2007 May 10. Recombinant porcine lactoferrin expressed in the milk of transgenic mice enhances offspring growth performance. Wu SC, Chen HL, Yen CC, Kuo MF, Yang TS, Wang SR, Weng CN, Chen CM, Cheng WT. Department of Animal Science and Technology, National Taiwan University, Taipei 106, Taiwan. The European Commission has proposed a permanent ban on the use of antibiotics as an ingredient in animal feed to promote growth. Lactoferrin is a globular multifunctional protein that has been shown to play a role in iron absorption and to have antimicrobial and anti-inflammatory activities. Therefore, lactoferrin may serve as a nontherapeutic alternative to antibiotics in livestock husbandry. As a pilot study toward this goal, transgenic mice have been generated harboring a porcine lactoferrin (pLF) gene driven by the mammary gland-specific promoter of the bovine alpha-lactalbumin (alphaLA) gene. The alphaLA-pLF hybrid gene was confirmed to have been successfully integrated and transmitted stably through the germ-line in 9 (5 females and 4 males) of 14 transgenic founders. In the female progenies of six lines analyzed, the transgene copy numbers ranged from 1 to 20 with 1-4 integration sites. Significant levels of pLF protein in milk ranging from 40 to 106 microg/mL with physical characteristics similar to those of native pLF in sow's milk were achieved in three of the transgenic lines obtained. Tissue- and stage-specific pLF expressions were restricted to the mammary gland of the transgenic female mice during lactation. It was further demonstrated that the growth performance of animal pups is enhanced by directly feeding the genetically engineered milk containing enriched pLF protein in transgenic mice. Furthermore, this enhanced growth performance in suckling mice was proportional to the concentration of pLF present in milk. Publication Types: Research Support, Non-U.S. Gov't PMID: 17489602 [PubMed - indexed for MEDLINE] 54: Nat Biotechnol. 2007 May;25(5):525-31. Functional foods from biotech--an unappetizing prospect? Powell K. kendall2@nasw.org In the early 1990s, functional foods promised to solve global malnutrition and put palatable options for treating ailments on grocery shelves. Since then, a meager number of products have ripened while the rest have turned sour. Publication Types: Review PMID: 17483833 [PubMed - indexed for MEDLINE] 55: Nat Biotechnol. 2007 May;25(5):507-8. Acceptance of GM food--an experiment in six countries. Knight JG, Mather DW, Holdsworth DK, Ermen DF. Publication Types: Letter Research Support, Non-U.S. Gov't PMID: 17483829 [PubMed - indexed for MEDLINE] 56: J Invertebr Pathol. 2007 Jul;95(3):175-80. Epub 2007 Mar 31. Microbial control and biotechnology research on Bacillus thuringiensis in China. Huang DF, Zhang J, Song FP, Lang ZH. Biotechnology Research Institute, Chinese Academy of Agricultural Sciences, Beijing 100081, China. dfhuang@mail.caas.net.cn The current status of production and application of biopesticides for pest control in China is briefly reviewed, with a focus on research advances in microbial control with Bacillus thuringiensis (Bt). These have led to improvements in Bt production, exploitation of Bt gene resources, and development of engineered Bt insecticides and transgenic Bt crops that have expanded host ranges and increased efficacy against target pests. Both conventional and biotechnology approaches need to be employed to achieve further progress in discovery, production technology, formulation processing, development of quality standards and recommended use patterns. Publication Types: Research Support, Non-U.S. Gov't PMID: 17481651 [PubMed - indexed for MEDLINE] 57: J Anim Sci. 2007 Aug;85(8):1946-52. Epub 2007 Apr 27. Corn expressing an Escherichia coli-derived phytase gene: a proof-of-concept nutritional study in pigs. Nyannor EK, Williams P, Bedford MR, Adeola O. Department of Animal Science, Purdue University, West Lafayette, IN 47907-2054, USA. Two experiments were conducted to investigate the concept that the addition of corn expressing an Escherichia coli-derived gene (corn-based phytase; CBP) to a P-deficient diet would improve growth performance and P utilization in pigs. An E. coli-derived microbial phytase (expressed in Pichia pastoris) sprayed onto a wheat carrier (Quantum) was included for comparison. In Exp. 1, forty-eight 10-kg pigs were blocked by BW into 6 blocks and allotted to 8 dietary treatments such that the BW among dietary treatments was similar and given free access to feed for 28 d. The dietary treatments were a negative control (NC) with no inorganic P supplementation; NC + 2, 4, or 6 g of monosodium phosphate/kg; NC + 16,500, 33,000, or 49,500 phytase units (FTU) of CBP/kg; and NC + 16,500 FTU of Quantum/kg. In Exp. 2, twenty-four 13-kg barrows were assigned to the NC, NC + 16,500 or 33,000 FTU of CBP/kg, or NC + 16,500 FTU of Quantum/kg, in a nutrient- and energy-balance study consisting of 5 d of adjustment and 5-d collection periods. The total collection method was used to determine nutrient and energy balance. Addition of CBP to the low-P NC diet linearly increased (P < 0.01) ADG, G:F, and plasma P concentration of pigs during the 28-d study. There was no difference in ADG, G:F, or plasma P concentration between pigs fed the CBP or Quantum phytase at 16,500 FTU/kg. Weight gain, G:F, and plasma P concentration of pigs increased (P < 0.01) with monosodium phosphate supplementation, confirming P deficiency of the NC diet. Linear improvements (P < 0.05) in DM digestibility and energy retention were observed with CBP supplementation of the NC diet. Although there were linear (P < 0.01) and quadratic (P < 0.05) increases in N digestibility, N retention was unaffected by CBP supplementation of the NC diet in growing pigs. Phosphorus and Ca digestibilities and retentions improved linearly and quadratically (P < 0.01) with the addition of CBP to the NC diet. There was no difference in digestive utilization of P or Ca between pigs fed CBP and Quantum phytase at 16,500 FTU/kg. The data showed that the addition of a corn expressing an E. coli-derived gene to a P-deficient diet improved growth performance and indices of P utilization in pigs, and corn expressing phytase was as efficacious as Quantum phytase when supplemented in P-deficient diets for weanling pigs. Publication Types: Comparative Study PMID: 17468432 [PubMed - indexed for MEDLINE] 58: Asia Pac J Clin Nutr. 2007;16(2):375-80. Attitudes of agricultural scientists in Indonesia towards genetically modified foods. Februhartanty J, Widyastuti TN, Iswarawanti DN. SEAMEO-TROPMED, RCCN, University of Indonesia, Campus of UI Salemba, Salemba Raya no. 6, Jakarta 10430, Indonesia. jfebruhartanty@seameo-rccn.org Conflicting arguments and partial truths on genetically modified (GM) foods have left confusion. Although studies of consumer acceptance of GM foods are numerous, the study of scientists is limited. Therefore, the main objective of this study was to assess the attitudes of scientists towards GM foods. The study was a cross sectional study. A total of 400 scientists (involved in at least one of teaching, research and consultancy) in the Bogor Agricultural Institute, Indonesia were selected randomly from its faculties of agriculture, veterinary, fishery, animal husbandry, forestry, agricultural technology, mathematics and science, and the post graduate department. Data collection was done by face-to-face interview using a structured questionnaire and self-administered questionnaire. The result showed that the majority (72.8%) of the respondents were favorably disposed towards GM foods, 14.8% were neutral, and only 12.5% were against them. The majority (78.3%) stated that they would try GM food if offered. Most (71%) reported that they were aware of the term "GM foods". Only half of the respondents felt that they had a basic understanding about GM foods. However, based on a knowledge test, 69.8% had a good knowledge score. Nearly 50% indicated that they were more exposed to news which supported GM foods. Over 90% said that there should be some form of labeling to distinguish food containing GM ingredients from non-GM foods. Attitudes were significantly associated with willingness to try GM foods if offered, restrictions on GM foods, and exposure to media reports about the pros and cons of GM foods. PMID: 17468097 [PubMed - indexed for MEDLINE] 59: Crit Rev Food Sci Nutr. 2007;47(4):335-61. The politics and science behind GMO acceptance. Varzakas TH, Arvanitoyannis IS, Baltas H. T. H. Varzakas Technological Educational Institute of Kalamata, School of Agricultural Sciences, Department of Processing of Agricultural Products, Hellas, Greece. The question of nutritional quality has arisen in the International Community over the last few years along with other important issues such as population aging, multipopulation societies, and political conflicts. The nutritional issue is questioned both quantitatively and qualitatively. It is well known that the planet faces enormous problems with food that is available. Nowadays 20% of the population consumes approximately 80% of the produced energy and natural resources. During the last 15 years, a series of food scares and crises (BSE, dioxin, foot and mouth disease, bird flu) have seriously undermined public confidence in food producers and operators and their capacity to produce safe food. As a result, food safety has become a top priority of the European legislative authorities. Genetically Modified Organisms (GMOs) is the new food safety concern which despite the intense reactions from Non Governmental Organizations and consumer organizations have entered our lives with inadequate legislative measures to protect consumers from their consumption. The GMO issue will be the issue for discussion in the long run not only for the European Community but also for the international community as far as scientific, economical, political, ideological, ethical, and human issues are concerned. These issues are discussed in this paper along with a case of study of GM fish. Publication Types: Review PMID: 17457721 [PubMed - indexed for MEDLINE] 60: J Sep Sci. 2007 Mar;30(4):579-85. A simple capillary gel electrophoresis approach for efficient and reproducible DNA separations. Analysis of genetically modified soy and maize. Sanchez L, Gonzalez R, Crego AL, Cifuentes A. Institute of Industrial Fermentations (CSIC), Juan de la Cierva 3, Madrid, Spain. It is generally assumed that in order to achieve suitable separations of DNA fragments, capillary gel electrophoresis (CGE)-coated capillaries should be used. In this work, a new method is presented that allows to obtain reproducible CGE separations of DNA fragments using bare fused-silica capillaries without any previous coating step. The proposed method only requires: (i) a capillary washing with 0.1 M hydrochloric acid between injections and (ii) a running buffer composed of Tris-phosphate-ethylenediamine tetraacetic acid (EDTA) and 4.5% of 2-hydroxyethyl cellulose (HEC) as sieving polymer. The use of this new CGE procedure gives highly resolved and reproducible separations of DNA fragments ranging from 50 to 750 bp. The separation of these DNA fragments is accomplished in less than 30 min with efficiencies up to 1.7 x 10(6) plates/m. Reproducibility values of migration times (given as %RSD) for the analyzed DNA fragments are better than 1.0% (n = 4) for the same day, 2.2% (n = 16) for four different days, and 2.3% (n = 16) for four different capillaries. The usefulness of this separation method is demonstrated by detecting genetically modified maize and genetically modified soy after DNA amplification by PCR. This new CGE procedure together with LIF as detector provides sensitive analysis of 0.9% of Bt11 maize, Mon810 maize, and Roundup Ready soy in flours with S/ N up to 542. These results demonstrate the usefulness of this procedure to fulfill the European regulation on detection of genetically modified organisms in foods. Publication Types: Research Support, Non-U.S. Gov't PMID: 17444227 [PubMed - indexed for MEDLINE] 61: Trends Biotechnol. 2007 Jun;25(6):239-41. Epub 2007 Apr 12. Reduced terpene levels in cottonseed add food to fiber. Townsend BJ, Llewellyn DJ. CSIRO Plant Industry, GPO Box 1600, Canberra, ACT 2601, Australia. belinda.townsend@bbsrc.ac.uk Using RNA interference (RNAi) technology, the levels of a toxic phytoprotectant have recently been reduced specifically in the seeds of cotton to generate a novel dual-purpose crop. By engineering an endogenous terpene pathway, there is now the exciting potential for an added-value, genetically modified crop with the cash value of the fiber supported by the improved nutritional value and expanded food and feed use for the cottonseed, which is normally a low-value by-product. Publication Types: Review PMID: 17433845 [PubMed - indexed for MEDLINE] 62: J Agric Food Chem. 2007 May 2;55(9):3268-74. Epub 2007 Apr 4. Toward metrological traceability for DNA fragment ratios in GM quantification. 3. Suitability of DNA calibrants studied with a MON 810 corn model. Charels D, Broeders S, Corbisier P, Trapmann S, Schimmel H, Emons H. European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, IRMM, Retieseweg 111, 2440 Geel, Belgium. diana.charels@ec.europa.eu The quantification of GMOs by real-time PCR relies on an external calibrant. In this paper the suitability of two DNA calibrants, genomic DNA from plant leaves and plasmidic DNA, was investigated. The PCR efficiencies, the correlation coefficients of the calibration curves, and the ratios between PCR efficiencies of transgenic and endogenous sequences were compared for both calibrants using 59 data sets produced by 43 laboratories. There were no significant differences between plasmidic and genomic DNA except for the PCR efficiencies of the calibration curves for the transgene of the construct-specific real-time PCR method. In the GM system investigated, PCR efficiencies of plasmidic calibrants were slightly closer to the PCR efficiencies observed for the unknowns than those of the genomic DNA calibrant. Therefore, plasmidic DNA was the more suitable calibrant for the PCR measurements on genomic DNA extracted from MON 810 seeds. It is shown that plasmidic DNA is an appropriate choice for the calibration of measurements of MON 810 corn with respect to the DNA copy number ratio. PMID: 17407307 [PubMed - indexed for MEDLINE] 63: J Agric Food Chem. 2007 May 2;55(9):3258-67. Epub 2007 Apr 4. Toward metrological traceability for DNA fragment ratios in GM quantification. 2. Systematic study of parameters influencing the quantitative determination of MON 810 corn by real-time PCR. Charels D, Broeders S, Corbisier P, Trapmann S, Schimmel H, Linsinger T, Emons H. European Commission, Joint Research Centre, Institute for Reference Materials and Measurements (IRMM), Retieseweg 111, 2440 Geel, Belgium. diana.charels@ec.europa.eu This paper is part of a set of three papers investigating metrological traceability of the quantification of DNA fragments as, for instance, used for quantification of genetic modifications. This paper evaluates the possible impact of several factors on results of real-time Polymerase Chain Reaction (PCR) measurements. It was found that the particle size of the powder samples does not have an influence, whereas the nature of the calibrant (plasmidic or genomic DNA) has a significant effect. Moreover, two real-time PCR detection methods (construct-specific and event-specific) for MON 810 corn were compared. The results obtained in a specifically designed interlaboratory study revealed a significant influence of the DNA extraction method on measurement results when the MON 810 construct-specific real-time PCR detection method was applied. Statistical analyses confirmed the importance of validating DNA extraction methods in conjunction with real-time PCR methods. PMID: 17407306 [PubMed - indexed for MEDLINE] 64: J Agric Food Chem. 2007 May 2;55(9):3249-57. Epub 2007 Apr 4. Toward metrological traceability for DNA fragment ratios in GM quantification. 1. Effect of DNA extraction methods on the quantitative determination of Bt176 corn by real-time PCR. Corbisier P, Broothaerts W, Gioria S, Schimmel H, Burns M, Baoutina A, Emslie KR, Furui S, Kurosawa Y, Holden MJ, Kim HH, Lee YM, Kawaharasaki M, Sin D, Wang J. European Commission, Joint Research Centre, Institute for Reference Materials and Measurements (IRMM), Retieseweg 111, 2440 Geel, Belgium. philippe.corbisier@ec.europa.edu. An international CCQM-P60 pilot study involving eight national metrological institutes was organized to investigate if the quantification of genetically modified (GM) corn powder by real-time PCR was affected by the DNA extraction method applied. Four commonly used extraction methods were compared for the extraction of DNA from a GM Bt176 corn powder. The CTAB-based method yielded the highest DNA template quantity and quality. A difference in the 260 nm/230 nm absorbance ratio was observed among the different extraction methods. Real-time amplification of sequences specific for endogenous genes zein and hmg as well as transgenic sequences within the cryIA(b) gene and a fragment covering the junction between the transformed DNA and the plant genome were used to determine the GM percentage. The detection of the transgenic gene was affected by the quantity and quality of template used for the PCR reaction. The Bt176 percentages measured on diluted or purified templates were statistically different depending on the extraction method applied. PMID: 17407305 [PubMed - indexed for MEDLINE] 65: EMBO Rep. 2007 Apr;8(4):305-8. Comment in: EMBO Rep. 2007 Apr;8(4):309-15. EMBO Rep. 2007 Jul;8(7):612-3. The precautionary principle should not be used as a basis for decision-making. Talking point on the precautionary principle. Peterson M. Department of History and Philosophy of Science, University of Cambridge, UK. mbp24@cam.ac.uk PMID: 17401402 [PubMed - indexed for MEDLINE] 66: J Fish Dis. 2007 Apr;30(4):201-12. Evaluation of stress- and immune-response biomarkers in Atlantic salmon, Salmo salar L., fed different levels of genetically modified maize (Bt maize), compared with its near-isogenic parental line and a commercial suprex maize. Sagstad A, Sanden M, Haugland O, Hansen AC, Olsvik PA, Hemre GI. National Institute of Nutrition and Seafood Research, NIFES, Bergen, Norway. The present study was designed to evaluate if genetically modified (GM) maize (Bt maize, event MON810) compared with the near-isogenic non-modified (nGM) maize variety, added as a starch source at low or high inclusions, affected fish health of post-smolt Atlantic salmon, Salmo salar L. To evaluate the health impact, selected stress- and immune-response biomarkers were quantified at the gene transcript (mRNA) level, and some also at the protein level. The diets with low or high inclusions of GM maize, and its near-isogenic nGM parental line, were compared to a control diet containing GM-free suprex maize (reference diet) as the only starch source. Total superoxide dismutase (SOD) activity in liver and distal intestine was significantly higher in fish fed GM maize compared with fish fed nGM maize and with the reference diet group. Fish fed GM maize showed significantly lower catalase (CAT) activity in liver compared with fish fed nGM maize and to the reference diet group. In contrast, CAT activity in distal intestine was significantly higher for fish fed GM maize compared with fish fed reference diet. Protein level of heat shock protein 70 (HSP70) in liver was significantly higher in fish fed GM maize compared with fish fed the reference diet. No diet-related differences were found in normalized gene expression of SOD, CAT or HSP70 in liver or distal intestine. Normalized gene expression of interleukin-1 beta in spleen and head-kidney did not vary significantly between diet groups. Interestingly, fish fed high GM maize showed a significantly larger proportion of plasma granulocytes, a significantly larger sum of plasma granulocyte and monocyte proportions, but a significantly smaller proportion of plasma lymphocytes, compared with fish fed high nGM maize. In conclusion, Atlantic salmon fed GM maize showed some small changes in stress protein levels and activities, but none of these changes were comparable to the normalized gene expression levels analysed for these stress proteins. GM maize seemed to induce significant changes in white blood cell populations which are associated with an immune response. Publication Types: Comparative Study PMID: 17394522 [PubMed - indexed for MEDLINE] 67: Appetite. 2007 Jul;49(1):1-17. Epub 2007 Feb 24. Consumer acceptance of technology-based food innovations: lessons for the future of nutrigenomics. Ronteltap A, van Trijp JC, Renes RJ, Frewer LJ. Marketing and Consumer Behaviour Group, Wageningen University and Research Centre, Hollandseweg 1, 6706 KN Wageningen, The Netherlands. amber.ronteltap@wur.nl Determinants of consumer adoption of innovations have been studied from different angles and from the perspectives of various disciplines. In the food area, the literature is dominated by a focus on consumer concern. This paper reviews previous research into acceptance of technology-based innovation from both inside and outside the food domain, extracts key learnings from this literature and integrates them into a new conceptual framework for consumer acceptance of technology-based food innovations. The framework distinguishes 'distal' and 'proximal' determinants of acceptance. Distal factors (characteristics of the innovation, the consumer and the social system) influence consumers' intention to accept an innovation through proximal factors (perceived cost/benefit considerations, perceptions of risk and uncertainty, social norm and perceived behavioural control). The framework's application as a tool to anticipate consumer reaction to future innovations is illustrated for an actual technology-based innovation in food science, nutrigenomics (the interaction between nutrition and human genetics). Publication Types: Research Support, Non-U.S. Gov't Review PMID: 17382433 [PubMed - indexed for MEDLINE] 68: Trends Biotechnol. 2007 May;25(5):201-3. Epub 2007 Mar 19. Food from cloned animals is part of our brave old world. Miller HI. The Hoover Institution, Stanford University, Stanford, CA 94305-6010, USA. miller@hoover.stanford.edu When confronted by pressure from activists and Congress, the US Food and Drug Administration (FDA) has not always adopted policies and made decisions about individual products that accord with the scientific evidence. An example was the unnecessarily and markedly prolonged review of the veterinary drug bovine somatotropin (bST), or bovine growth hormone, during the 1980s. The FDA now faces a similar situation surrounding the question of whether meat and milk from cloned animals and their offspring are safe for human consumption. Having made a preliminary decision in the affirmative - based on an exhaustive analysis of scientific articles, health records, blood samples and studies of the composition of meat and milk - the agency has been beleaguered by criticisms. It remains to be seen whether, ultimately, science will trump anti-technology, anti-consumer activism. Publication Types: Review PMID: 17374411 [PubMed - indexed for MEDLINE] 69: Rev Biol Trop. 2004 Sep;52(3):727-32. [Relationship of genetically modified crops with the environment and health of the Costa Rican human population] [Article in Spanish] Espinoza AM, Arrieta-Espinoza G, Sittenfeld A. Centro de Investigacion en Biologia Celular y Molecular, Universidad de Costa Rica, Ciudad Universitaria Rodrigo Facio, San Jose, Costa Rica. amespino@racsa.co.cr Genetic engineering and the food derived from genetically modified crops (GMCs) have been the center of debate worldwide, as has occurred historically with the advent of new technologies. Questions are derived from the potential impact of GMCs to the environment and the safety of the products to the consumers. In relation to the first inquiry, practice has been oriented to a case-by-case-study, according to the own characteristics of the GMC, in order to minimize its impact in the environment. Scientific studies in diverse latitudes of the world have demonstrated that GMCs in the market showed no adverse effects related to this issue. In relation to food derived from the GMCs, rigorous evaluation protocols have been developed and approved by FAO and WHO to guarantee the innocuousness of these products. Up to the moment, no contraindications for human health have been pointed out for the products that are available today in the market. In the particular case of Costa Rica, the country has established since the 90s a regulatory biosafety framework for the management of the GMCs, safeguarding the biodiversity of the country and the health of consumers. At the same time the country has made significant public and private investments in the field that allowed the country to obtain a leading position in biosafety in the region and genetic engineering research at national research centers. Any attempt to restrict or prohibit these activities in the country, will put in risk the previously described investment, will affect the generation of new knowledge for decision making and the leadership in the field, preventing the benefits derived from this promising technology. Publication Types: English Abstract PMID: 17361565 [PubMed - indexed for MEDLINE] 70: Sci Am. 2007 Mar;296(3):8. The beef with cloned meat. [No authors listed] PMID: 17348147 [PubMed - indexed for MEDLINE] 71: Nat Biotechnol. 2007 Mar;25(3):282-3. Comment on: Nat Biotechnol. 2007 Jan;25(1):1. Two views of the emperor's new clones. Schubert D. Publication Types: Comment Letter PMID: 17344873 [PubMed - indexed for MEDLINE] 72: Nat Biotechnol. 2007 Mar;25(3):281. Comment on: Nat Biotechnol. 2007 Jan;25(1):1. Two views of the emperor's new clones. Miller HI. Publication Types: Comment Letter PMID: 17344872 [PubMed - indexed for MEDLINE] 73: Toxicol Sci. 2007 May;97(1):27-31. Epub 2007 Mar 3. The utility of an international sera bank for use in evaluating the potential human allergenicity of novel proteins. Thomas K, Bannon G, Herouet-Guicheney C, Ladics G, Lee L, Lee SI, Privalle L, Ballmer-Weber B, Vieths S. International Life Sciences Institute Health and Environmental Sciences Institute, Washington, District of Columbia 20005, USA. kthomas@ilsi.org In the safety assessment of novel foods produced through biotechnology, careful consideration is given to determining the allergenic potential of newly introduced proteins. IgE serum screening is one tool for evaluating whether the protein in question has sequence identity to a known allergen or if the source of the gene encoding the protein is a known allergenic food. A "specific" serum screen involves testing a gene product with sera from patients with documented clinical allergy to a specific allergen to confirm that the gene product of interest is not the same protein to which the patient produces IgE antibodies. A "targeted" serum screen involves testing the gene product of interest with sera from patients sensitive to food or aeroallergens from the same broad group. The concept of a global sera bank with accessible, well-characterized sera for use in such assays is an appealing option. This paper summarizes the consensus elements from a workshop to evaluate the potential utility of an international sera bank for evaluating the allergenicity of novel proteins. Areas of agreement following the workshop included the following: (1) specific sera screens are appropriate for exploring potentially cross-reactive proteins that have been identified through bioinformatics analyses; however, additional validation is needed, particularly for targeted sera screens, (2) practical and ethical considerations may preclude the formation of a global sera bank, and therefore, (3) a regional network of clinicians who could serve as sources of patient sera or be approached to conduct sera studies would be the most practical alternative. Publication Types: Congresses Research Support, Non-U.S. Gov't PMID: 17337755 [PubMed - indexed for MEDLINE] 74: Vopr Pitan. 2006;75(6):55-60. [The comparative characteristic of detection methods for genetically modified organisms phytogenous] [Article in Russian] Anisimova OV, Kashina NA, Chernysheva ON, Tutel'ian VA. In the article given description, comparative characteristic and used in practice detection methods for genetically modified organisms (GMOs) in food using chip and electrophoreses. By means of these methods fined research results 704 foods that had GM analogue on the food world market. The both methods showed to identical results of research. These methods were not discovered essential distinctions in the sensibility and reliability. Publication Types: Comparative Study English Abstract PMID: 17313048 [PubMed - indexed for MEDLINE] 75: J Fish Dis. 2007 Feb;30(2):65-79. Histological, digestive, metabolic, hormonal and some immune factor responses in Atlantic salmon, Salmo salar L., fed genetically modified soybeans. Bakke-McKellep AM, Koppang EO, Gunnes G, Sanden M, Hemre GI, Landsverk T, Krogdahl A. Aquaculture Protein Centre, CoE, Norway. anne.mckellep@veths.no The paper reports the second and final part of an experiment aiming to study physiological and health-related effects of genetically modified (GM) soybean meal (SBM) type Roundup Ready soybean (RRS) in diets for post-smolt Atlantic salmon. For 3 months salmon were fed diets containing 172 g kg(-1) full-fat SBM from RRS (GM-soy) or an unmodified, non-isogenic line (nGM-soy), or a reference diet with fishmeal as the sole protein source (FM). Slight differences in anti-nutrient levels were observed between the GM and nGM-soy. Histological changes were observed only in the distal intestine of the soy-fed fish. The incidence of moderate inflammation was higher in the GM-soy group (9 of 10 sampled fish) compared with the nGM-soy group (7 of 10). However, no differences in the concomitant decreases in activities of digestive enzymes located in the brush border (leucine aminopeptidase and maltase) and apical cytoplasm (acid phosphatase) of enterocytes or in the number of major histocompatibility complex class II+ cells, lysozyme activity, or total IgM of the distal intestine were observed. GM compared with nGM-soy fed fish had higher head kidney lysozyme (11,856 vs. 10,456 units g(-1) tissue) and a tendency towards higher acid phosphatase (0.45 vs. 0.39 micromol h(-1) kg(-1) body mass in whole tissue) activities, respectively. Plasma insulin and thyroxin levels, and hepatic fructose-1,6-bisphosphatase and ethoxyresorufin-O-deethylase activities were not significantly affected. It is not possible, however, to conclude whether the differences in responses to GM-soy were due to the genetic modification or to differences in soy cultivars in the soy-containing diets. Results from studies using non-modified, parental line soybeans as the control group are necessary to evaluate whether genetic modification of soybeans in diets poses any risk to farmed Atlantic salmon. Publication Types: Comparative Study Research Support, Non-U.S. Gov't PMID: 17298562 [PubMed - indexed for MEDLINE] 76: Nat Biotechnol. 2007 Feb;25(2):165; discussion 165-6. Comment on: Nat Biotechnol. 2006 Oct;24(10):1177. Blame factory farming, not organic food. Holdrege C. Publication Types: Comment Letter PMID: 17287741 [PubMed - indexed for MEDLINE] 77: Immunol Allergy Clin North Am. 2007 Feb;27(1):105-27. New perspectives for use of native and engineered recombinant food proteins in treatment of food allergy. Nowak-Wegrzyn A. Jaffe Food Allergy Institute, Division of Allergy and Immunology, Department of Pediatrics, Mount Sinai School of Medicine, Box 1198, One G. Levy Place, NY 10029, USA. anna.nowak-wegrzyn@mssm.edu Food allergy has emerged as an important target for research on curative treatment and prevention, with most efforts focusing on peanut, cow's milk, and egg allergy. This article reviews the recent developments in the potential treatments for IgE-mediated food allergy using native and engineered recombinant food proteins. Publication Types: Research Support, N.I.H., Extramural Review PMID: 17276882 [PubMed - indexed for MEDLINE] 78: Food Chem Toxicol. 2007 Apr;45(4):530-42. Epub 2006 Aug 25. Approaches in the risk assessment of genetically modified foods by the Hellenic Food Safety Authority. Varzakas TH, Chryssochoidis G, Argyropoulos D. Hellenic Food Safety Authority (EFET), Directorate of Nutritional Policy and Research, Karystou 5, 115 23 Ampelokipoi, Greece. theovarzakas@yahoo.gr Risk analysis has become important to assess conditions and take decisions on control procedures. In this context it is considered a prerequisite in the evaluation of GM food. Many consumers worldwide worry that food derived from genetically modified organisms (GMOs) may be unhealthy and hence regulations on GMO authorisations and labelling have become more stringent. Nowadays there is a higher demand for non-GM products and these products could be differentiated from GM products using the identity preservation system (IP) that could apply throughout the grain processing system. IP is the creation of a transparent communication system that encompasses HACCP, traceability and related systems in the supply chain. This process guarantees that certain characteristics of the lots of food (non-GM origin) are maintained "from farm to fork". This article examines the steps taken by the Hellenic Food Safety Authority to examine the presence of GMOs in foods. The whole integrated European legislation framework currently in place still needs to be implemented in Greece. Penalties should be enforced to those who import, process GMOs without special licence and do not label those products. Similar penalties should be enforced to those companies that issue false certificates beyond the liabilities taken by the food enterprises for farmers' compensation. We argue that Greece has no serious reasons to choose the use of GMOs due to the fact that the structural and pedologic characteristics of the Greek agriculture favour the biological and integrated cultivation more. Greece is not in favour of the politics behind coexistence of conventional and GM plants and objects to the use of GMOs in the food and the environment because the processor has a big burden in terms of money, time and will suffer a great deal in order to prove that their products are GMO free or that any contamination is adventitious or technically unavoidable. Moreover, Greece owns a large variety of genetic material that should try to protect from patenting and commercialisation. Finally, we should be aware of the requirements of movement of GMOs within borders, i.e. GMOs grown or used in other countries but which are not intended to cross into Greece, since Greece is very close to countries that are non-EU. This is where the development of a new, integrated, trustworthy and transparent food quality control system will help to satisfy the societal demands for safe and quality products. On the other hand, Greece should not be isolated from any recent scientific technological development and should assess the possible advantages for some cultivation using a case by case approach. Finally, the safety assessment of GM foods and feed has been discussed according to the risk assessment methodology applied by EFSA. Publication Types: Review PMID: 17275157 [PubMed - indexed for MEDLINE] 79: Nature. 2007 Jan 11;445(7124):132-3. Out of bounds. [No authors listed] Publication Types: News PMID: 17215811 [PubMed - indexed for MEDLINE] 80: Nat Biotechnol. 2007 Jan;25(1):77-83. Risk assessment of meat and milk from cloned animals. Yang X, Tian XC, Kubota C, Page R, Xu J, Cibelli J, Seidel G Jr. Center for Regenerative Biology and Department of Animal Science, University of Connecticut, Storrs, Connecticut 06269-4243, USA. xiangzhong.yang@uconn.edu Research on, and commercialization of, cloned cattle has been conducted for more than 20 years. Early techniques relied on the physical splitting of embryos or using embryo cells for nuclear transfer to generate cloned animals. Milk and meat from these animals entered into the human food market with no evidence of problems. With the advent of nuclear transfer, which enables the direct transference and preservation of high-value meat- and milk-producing genotypes to offspring, concerns have been raised about whether the products from somatic cell nuclear transfer-produced animals are safe for human consumption. Studies on the biochemical properties of food products from cloned and noncloned animals have thus far not detected any differences. All data to date indicate no significant differences in the measured parameters between animals created by nuclear transfer and normally bred animals. Public acceptance of cloned animal products depends upon forthcoming US Food and Drug Administration approval along with convincing safety data. Publication Types: Review PMID: 17211406 [PubMed - indexed for MEDLINE] 81: Nat Biotechnol. 2007 Jan;25(1):47-53. Dolly for dinner? Assessing commercial and regulatory trends in cloned livestock. Suk J, Bruce A, Gertz R, Warkup C, Whitelaw CB, Braun A, Oram C, Rodriguez-Cerezo E, Papatryfon I. ESRC Genomics Policy & Research Forum, University of Edinburgh, St. John's Land, Edinburgh, Scotland. As cloning technologies become more widely established, will products enter the food chain sooner than regulatory agencies and the public might be prepared for? Publication Types: Research Support, Non-U.S. Gov't PMID: 17211395 [PubMed - indexed for MEDLINE] 82: Nat Biotechnol. 2007 Jan;25(1):39-43. Animal cloning and the FDA--the risk assessment paradigm under public scrutiny. Rudenko L, Matheson JC, Sundlof SF. Center for Veterinary Medicine, US Food and Drug Administration, Department of Health and Human Services, 7500 Standish Place, Rockville, Maryland 20855, USA. larisa.rudenko@fda.hhs.gov The evidence gathered thus far--ultimately to be published in the Draft Risk Assessment on Animal Cloning--indicates that there are no unique risks associated with animal cloning. Publication Types: Review PMID: 17211392 [PubMed - indexed for MEDLINE] 83: Nat Biotechnol. 2007 Jan;25(1):35-6; author reply 36-7. Comment on: Nat Biotechnol. 2005 Dec;23(12):1475-6. Nat Biotechnol. 2006 Jan;24(1):63-71. Early-tier tests insufficient for GMO risk assessment. Lang A, Lauber E, Darvas B. Publication Types: Comment Letter PMID: 17211390 [PubMed - indexed for MEDLINE] 84: Nat Biotechnol. 2007 Jan;25(1):33-4. Comment on: Nat Biotechnol. 2006 Oct;24(10):1178. Parallel biopolitical universes. Morris SH. Publication Types: Comment Letter PMID: 17211389 [PubMed - indexed for MEDLINE] 85: Nat Biotechnol. 2007 Jan;25(1):7-8. Epub 2007 Jan 5. FDA's cloning report bypasses ethics, exposes European dilemma. Vermij P. Publication Types: News PMID: 17211377 [PubMed - indexed for MEDLINE] 86: Nat Biotechnol. 2007 Jan;25(1):1. Comment in: Nat Biotechnol. 2007 Mar;25(3):281. Nat Biotechnol. 2007 Mar;25(3):282-3. The emperor's new clones. [No authors listed] If regulators conclude that food from clones poses no more risk than food from other animals, the US and Europe could be on course for another biotech trade war. Publication Types: Editorial PMID: 17211372 [PubMed - indexed for MEDLINE] 87: 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] 88: 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 - indexed for MEDLINE] 89: 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] 90: An Acad Bras Cienc. 2006 Dec;78(4):667-86. GMOs: building the future on the basis of past experience. Reis LF, Van Sluys MA, Garratt RC, Pereira HM, Teixeira MM. Ludwig Institute for Cancer Research, Sao Paulo, SP, Brazil. lreis@ludwig.org.br Biosafety of genetically modified organisms (GMOs) and their derivatives is still a major topic in the agenda of government and societies worldwide. The aim of this review is to bring into light that data that supported the decision taken back in 1998 as an exercise to stimulate criticism from the scientific community for upcoming discussions and to avoid emotional and senseless arguments that could jeopardize future development in the field. It must be emphasized that Roundup Ready soybean is just one example of how biotechnology can bring in significant advances for society, not only through increased productivity, but also with beneficial environmental impact, thereby allowing more rational use of agricultural pesticides for improvement of the soil conditions. The adoption of agricultural practices with higher yield will also allow better distribution of income among small farmers. New species of genetically modified plants will soon be available and society should be capable of making decisions in an objective and well-informed manner, through collegiate bodies that are qualified in all aspects of biosafety and environmental impact. Publication Types: Review PMID: 17143405 [PubMed - indexed for MEDLINE] 91: 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] 92: 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] 93: 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] 94: 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] 95: 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] 96: Nature. 2006 Nov 9;444(7116):137. A breed apart. [No authors listed] PMID: 17093424 [PubMed - indexed for MEDLINE] 97: 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] 98: 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] 99: 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] 100: 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]