Journal articles on the topic 'Canary seed proteins'

The bioactive properties and health-promoting effects of two novel yellow (C09052, C05041) and two brown (Calvi, Bastia) hairless canary seed (Phalaris canariensis L.) cultivars were investigated in comparison to two common cereal grains (wheat and oat). The cereal flours were digested using the standardized INFOGEST in vitro human gastrointestinal digestion model. The three-kilo dalton molecular weight cutoff (3 kDa MWCO) permeate of the generated digestates was assessed in vitro for their antioxidant, chelating, antihypertensive and antidiabetic activities. The results showed no significant differences in studied bioactivities between yellow and brown canary seed cultivars, except for antioxidant activity by the DPPH and chelating Fe2+ assays, where brown cultivars had higher activities. Canary seeds had superior or equivalent antioxidant activity than those from oat and wheat. The anti-hypertensive activity (Angiotensin-converting enzyme (ACE) inhibition) in yellow canary seed cultivars was significantly higher than that of oat and wheat, particularly for C09052 and Calvi varieties. Peptides exhibiting the highest antihypertensive activity from the permeate of the C09052 canary seed variety were further fractionated and identified by mass spectrometry. Forty-six peptides were identified belonging to 18 proteins from the Pooideae subfamily. Fourteen of the parent proteins were homologous to barley proteins. Peptides were analyzed in silico to determine potential bioactivity based on their amino acid composition. All 46 peptides had potential anti-hypertensive and anti-diabetic activities and 20 had potential antioxidant activity, thereby validating the in vitro assay data. Canary seed peptides also exhibited potential antiamnestic, antithrombotic, immunostimulating, opioid and neuro-activity, demonstrating important potential for health promoting effects, particularly against cardiovascular disease.

SDS-PAGE analysis of seed proteins was carried out to identify the cultivars in the forage crop, timothy (Phleum pratense L.). Nineteen cultivars of timothy were examined. Among them five were from Europe and fourteen from North America. In total fifty protein bands were detected in mature seed extract by SDS-PAGE followed by Coomassie blue staining. Except for two pairs, all the cultivars were differentiated by SDS-PAGE analysis of seed storage proteins. In the electrophoretic profile, no protein bands were found to be specific either to European or to North American cultivars which is an indication of their genetic similarity. Twelve samples of cultivar Toro harvested from Alberta and Manitoba (Canada), Idaho and Minnesota (USA) were compared and no significant differences were found in their seed protein banding patterns, which suggests environmental stability of timothy seed proteins.Key words: SDS PAGE, timothy cultivar identification, seed storage proteins

White prairie clover [Dalea candida (Michx.) Willd.] is native to the dry prairies and hillsides of the Northern Great Plains. A study was initiated in 2012 with six white prairie clover populations collected from the Canadian Prairies. Plant growth characteristics, forage biomass, seed yield, and forage nutritive values were evaluated using a randomized complete block design in a field near Swift Current, SK. Three populations from Argyle, Carlowrie, and Big Grass Marsh (NCP588) in Manitoba displayed erect-type growth while those from Douglas Provincial Park and Stewart Valley in Saskatchewan and Writing on Stone Provincial Park in Alberta exhibited prostrate growth. The populations did not differ for mean biomass yield (79–104 g plant−1, p = 0.54) and mean seed yield (6.6–9.1 g plant−1, p = 0.69); however, they differed for bloom stage nutritional parameters such as acid detergent fibre (25%–30%, p = 0.04), neutral detergent fibre (34%–41%, p < 0.01), crude proteins (15%–18%, p < 0.01), phosphorus (0.24%–0.29%, p = 0.02), and iron content (144–360 ppm, p = 0.01). To our knowledge, this is the first report of comparative phenotypic, nutritional, and propagation study of native white prairie clover populations of Canada. The constraints and opportunities for successful domestication of white prairie clover as a forage crop are discussed.

Abstract Assessing potency of mesenchymal stem/stromal cells (MSC) used for immunologic applications such as the treatment of GVHD or other inflammatory disorders has been a challenge. Expression of PD-L1 or production of indoleamine-pyrrole 2,3-dioxygenase (IDO-1) has been proposed as potential potency markers. To screen for other pathways involved with suppression we undertook proteomic analysis of IFN-γ stimulated MSC. MSC isolated and expanded from normal healthy donors to 70-80% confluence were treated overnight with human rIFN-γ (30ng/ml). MSC were harvested using TrypLE Select and then immunologic and proteomic studies were performed. IFN-γ exposure increased a) MSC expression of IDO-1 and PD-L1, b) MSC suppression of 3rd party T lymphocyte proliferation, c) MSC inhibition of development of IFN-γ producing T lymphocytes, and d) MSC promotion of Treg expansion. Cellular proteomic changes that occur with IFN-γ exposures were studied in paired samples of control and IFN-γ treated MSC. Samples were prepared using a modified Filter Aided Sample Prep (FASP) and digests were separated using 2D liquid chromatography and analysed by tandem mass spectrometry. Data was processed with the Global Proteome Machine and only proteins with at least two confident peptides were reported. A total of 7621 proteins were identified of which 5575 were seen in all samples and 232 proteins were significantly upregulated in the IFN-γ treated cells relative to their controls. The proteomic analysis identified constitutive proteins seen in MSC. The upregulated proteins were significantly enriched (p<10-17) for GO processes such as "response to IFN-γ" and "cytokine mediated signaling pathway". Known inhibitory mediators (such as IDO-1, PD-L1, PGE2, galectin-9) were upregulated. Interestingly adhesion molecules (ICAM-1, VCAM-1, and CCL9) were increased. Other proteins with increased expression include Bone Marrow Stromal 2 (BST2). Conclusion: Proteomic analysis of response of MSC to IFN-γ has identified a signature of proteins upregulated with the activation of immune suppressive functions of MSC. Once confirmed these findings will support the development of a potency test for immunosuppressive potential of given MSC preparations - something that is sorely needed in the clinical manufacturing of MSC products. Acknowledgments: Q.D. is holding a postdoctoral fellowship from MS Society of Canada. This research was supported by The Bihlers' Professorship in Stem Cell Research to D.W. Disclosures No relevant conflicts of interest to declare.

The acrosomal process of Limulus sperm is an 80-microns long finger of membrane supported by a crystalline bundle of actin filaments. The filaments in this bundle are crosslinked by a 102-kD protein, scruin present in a 1:1 molar ratio with actin. Recent image reconstruction of scruin decorated actin filaments at 13-A resolution shows that scruin is organized into two equally sized domains bound to separate actin subunits in the same filament. We have cloned and sequenced the gene for scruin from a Limulus testes cDNA library. The deduced amino acid sequence of scruin reflects the domain organization of scruin: it consists of a tandem pair of homologous domains joined by a linker region. The domain organization of scruin is confirmed by limited proteolysis of the purified acrosomal process. Three different proteases cleave the native protein in a 5-kD Protease-sensitive region in the middle of the molecule to generate an NH2-terminal 47-kD and a COOH-terminal 56-kD protease-resistant domains. Although the protein sequence of scruin has no homology to any known actin-binding protein, it has similarities to several proteins, including four open reading frames of unknown function in poxviruses, as well as kelch, a Drosophila protein localized to actin-rich ring canals. All proteins that show homologies to scruin are characterized by the presence of an approximately 50-amino acid residue motif that is repeated between two and seven times. Crystallographic studies reveal this motif represents a four beta-stranded fold that is characteristic of the "superbarrel" structural fold found in the sialidase family of proteins. These results suggest that the two domains of scruin seen in EM reconstructions are superbarrel folds, and they present the possibility that other members of this family may also bind actin.

Common bean (Phaseolus vulgaris L.) is a food crop that is an important source of dietary proteins and carbohydrates. Marsh spot is a physiological disorder that diminishes seed quality in beans. Prior research suggested that this disease is likely caused by manganese (Mn) deficiency during seed development and that marsh spot resistance is controlled by at least four genes. In this study, genetic mapping was performed to identify quantitative trait loci (QTL) and the potential candidate genes associated with marsh spot resistance. All 138 recombinant inbred lines (RILs) from a bi-parental population were evaluated for marsh spot resistance during five years from 2015 to 2019 in sandy and heavy clay soils in Morden, Manitoba, Canada. The RILs were sequenced using a genotyping by sequencing approach. A total of 52,676 single nucleotide polymorphisms (SNPs) were identified and filtered to generate a high-quality set of 2066 SNPs for QTL mapping. A genetic map based on 1273 SNP markers distributed on 11 chromosomes and covering 1599 cm was constructed. A total of 12 stable and 4 environment-specific QTL were identified using additive effect models, and an additional two epistatic QTL interacting with two of the 16 QTL were identified using an epistasis model. Genome-wide scans of the candidate genes identified 13 metal transport-related candidate genes co-locating within six QTL regions. In particular, two QTL (QTL.3.1 and QTL.3.2) with the highest R2 values (21.8% and 24.5%, respectively) harbored several metal transport genes Phvul.003G086300, Phvul.003G092500, Phvul.003G104900, Phvul.003G099700, and Phvul.003G108900 in a large genomic region of 16.8–27.5 Mb on chromosome 3. These results advance the current understanding of the genetic mechanisms of marsh spot resistance in cranberry common bean and provide new genomic resources for use in genomics-assisted breeding and for candidate gene isolation and functional characterization.

In Drosophila oogenesis, several morphogenetic determinants and other developmental factors synthesized in the nurse cells have been shown to accumulate in the oocyte during pre- to mid-vitellogenic stages. However, the mechanisms of the involved intercellular transport processes that seem to be rather selective have not been revealed so far. We have investigated in vitro, by means of video-enhanced contrast time-lapse microscopy, the transport of cytoplasmic particles from the nurse cells through ring canals into the oocyte during oogenesis stages 6–10A. At stage 7, we first observed single particles moving into the previtellogenic oocyte. The particle transfer was strictly unidirectional and seemed to be selective, since only some individual particles moved whereas other particles lying in the vicinity of the ring canals were not transported. The observed transport processes were inhibitable with 2,4-dinitrophenol, cytochalasin B or N-ethylmaleimide, but not with microtubule inhibitors. At the beginning of vitellogenesis (stage 8), the selective translocation of particles through the ring canals became faster (up to 130 nm/second) and more frequent (about 1 particle/minute), whereas during mid-vitellogenesis (stages 9–10A) the velocity and the frequency of particle transport decreased again. Following their more or less rectilinear passage through the ring canals, the particles joined a circular stream of cytoplasmic particles in the oocyte. This ooplasmic particle streaming started at stage 6/7 with velocities of about 80 nm/second and some reversals of direction at the beginning. The particle stream in the oocyte was sensitive to colchicine and vinblastine, but not to cytochalasin B, and we presume that it reflects the rearrangement of ooplasmic microtubules described recently by other authors. We propose that during stages 7–10A, a selective transport of particles into the oocyte occurs through the ring canal along a polarized scaffold of cytoskeletal elements in which microfilaments are involved. This transport might be driven by a myosin-like motor molecule. Either attached to, or organized into, such larger particles or organelles, specific mRNAs and proteins might become selectively transported into the oocyte.

Genetic technologies have become a tool for achieving the desired properties of plant crops instead of traditional breeding in recent decades. They consist in artificial editing of a plant genome (genetic modification) by inserting the genes encoding desired features from the DNA of one organism in another, often unrelated, species. One of the most popular crops is soybean containing up to 38–42% of proteins in its seeds, and its most common type is GTS 40-3-2 (Monsanto Canada Inc.) line of transgenic soybean. The genetically modified soybean "Roundup Ready" is resistant to the action of herbicide "Roundup" (it continues to grow when it is cultivated with this herbicide). Therefore, the study of individual and combined effects of both factors on the free radical oxidation processes in biomolecules is very relevant. Experimental research was performed on 4-month Wistar rats to study the long-term effects of feeding with genetically modified soybean and herbicide "Roundup", both separately and together, on the rat kidneys. The results of the study showed that after 12 months of feeding with genetically modified soybean treated with herbicide "Roundup" (IV group) and receiving the herbicide with drinkable water (V group), there was an increase in the level of carbonyl derivatives in the rat kidney homogenates in the first (F0) and in subsequent generations (F1, F2) of rats. The research results showed that the highest level of carbonyl derivatives was noted in the kidneys of the third generation of rats. Along with the increase in oxidatively modified proteins in the rat kidney homogenates, there was a decrease in the content of sulfhydryl groups and proteolytic enzymes in the IV and V groups, the lowest level was observed in the third generation. The use of the same transgenic soybean variety not treated with any herbicide did not lead to an increase in the level of carbonyl derivatives and a decrease in the content of sulfhydryl groups compared to control group rats. Thus, the obtained experimental data indicate that both feeding with the genetically modified soybean treated with the herbicide and receiving the herbicide "Roundup" with drinkable water lead to the initiation of free radical processes in the kidneys of rats of all three generations and imbalance of the oxidant–antioxidant system, most notably in the third generation of rats. Such research results indicate the negative effects of the investigated factors and indicate that the herbicide "Roundup" may be accumulated in the seeds of transgenic soybean and also it may increase the oxidative modification of proteins in the rat kidneys. Hence, it is necessary to carry out a detailed study of the effects of these factors on histochemical changes in the kidney and liver structure and an investigation of antioxidant enzyme activity in these organs.

Eating well with Canada’s food guide (CFG) was developed by Health Canada as an education tool to encourage the Canadian public to have eating habits that meet nutrient needs, promote health, and reduce the risk of nutrition-related chronic disease. It was developed in the Canadian context and reflects the food supply available to Canadians, as well as food choices made by Canadians. There are other dietary patterns that are consistent with health such as the traditional Mediterranean diet (TMD), which has gained popularity in Canada. The potentially different food choices that Canadians could make if they were to follow one guide over the other might significantly influence population health. Although the two guides differ in their recommendations for red wine, fats, and meat and meat alternatives, they both promote a diet rich in grains, fruits, and vegetables. The CFG may have some advantages over the TMD for Canadians, such as focusing on vitamin D and recommending limited alcoholic beverage intake. Some shortcomings of the CFG compared with the TMD are the grouping of animal proteins with nuts, seeds, and legumes into a single category, and not recommending limits for red meat consumption. If Canadians following the CFG were to choose whole grains and vegetarian options from the meat and alternatives category more often, the CFG may be preferable to TMD for Canadians. The TMD is an alternative to the CFG for Canadians if sources of vitamin D are included in the diet and wine consumption is limited or is imbibed in moderation.

Abstract Abstract 3426 Introduction: Paroxysmal Nocturnal Hemoglobinuria (PNH) is a rare disorder due to a somatic mutation in the hematopoietic stem cell. The introduction of highly sensitive flow cytometric and aerolysin testing have shown the presence of PNH clones in patients with a variety of other hematological disorders such as aplastic anemia (AA) and myelodysplasic syndrome (MDS). It is hypothesized that patients with these disorders and PNH clones may share an immunologic basis for marrow failure with relative protection of the PNH clone, due to their lack of cell surface expression of immune accessory proteins. This is supported by the literature showing responsiveness in AA and MDS to immunosuppressive treatments. Preliminary results from a recent multicenter trial, EXPLORE, notes that PNH clones can be seen in 70% of AA and 55% of MDS patients, and therefore there may be utility in the general screening of all patients with bone marrow failure (BMF) syndromes. Furthermore, it has been suggested that the presence of PNH cells in MDS is a predictive biomarker that is clinically important for response to immunosuppressive therapy. Methods: Our retrospective cohort study in a tertiary care center used a high sensitivity RBC and FLAER assay to detect PNH clones as small as 0.01%. Of all patients screened with this method, those with bone marrow biopsy and aspirate proven MDS, AA, or other BMF syndromes (defined as unexplained cytopenias) were analysed. Results from PNH assays were compared to other clinical and laboratory parameters such as LDH. Results: Overall, 102 patients were initially screened over a 12 month period at our center. 30 patients were excluded as they did not have biopsy or aspirate proven MDS, AA, or other BMF syndromes. Of the remaining 72 patients, four patients were found to have PNH clones, where 2/51 had MDS (both RCMD, IPSS 0) [3.92%] and 2/4 had AA [50%]. The PNH clone sizes of these four patients were 0.01%, 0.01%, 0.02%, and 1.7%. None of the MDS patients with known recurrent karyotypic abnormalities had PNH clones present. Only one of the four patients had a markedly increased serum LDH level. Conclusions: Our retrospective study indicates much lower incidence of PNH clones in MDS patients or any patients with BMF syndromes when compared to the preliminary data from the EXPLORE trial. There is also significant disagreement in other smaller cohorts in regards to the incidence of PNH in AA and MDS. Screening for PNH clones in patients with bone marrow failure needs further study before adoption of widespread use. Disclosures: Keeney: Alexion Pharmaceuticals Canada Inc.: Consultancy, Membership on an entity's Board of Directors or advisory committees. Wells:Alexion Pharmaceuticals Canada Inc: Honoraria. Sutherland:Alexion Pharmaceuticals Canada Inc.: Consultancy, Membership on an entity's Board of Directors or advisory committees.

Conifer biotechnology research has proceeded at a rapid rate of development in the 3 years since the last International Conifer Tissue Culture Work Group (ICTCWG) meeting. Since the first detailed account in 1985, somatic embryo induction has become a routine technique in many laboratories, and direct protoplast regeneration to somatic embryos has now been reported. The Fourth Meeting of the ICTCWG, which was held in Saskatoon between August 8 and 12, 1988, was therefore timely and was attended by 90 participants representing 10 countries. The meeting comprised 10 invited keynote speakers, 32 contributed oral and 21 contributed poster presentations. The topics covered the fuller scope of conifer biotechnology as it is now evolving. In the area of regeneration from zygotic embryos by organogenesis, contributed papers described the considerable progress being made toward controlled shoot and root induction, these were exemplified by the data provided by John Frampton (North Carolina State University, Raleigh) on field performance of tissue cultured plants. In-depth studies of the physiological and biochemical events associated with regeneration are yielding results pertinent to recalcitrant species, according to Trevor Thorpe (University of Calgary, Alberta). Further, Wesley Hackett (University of Minnesota, St. Paul) considered that the study of cellular and biochemical characteristics associated with maturation would help in understanding phase change and assist in the propagation efforts.Somatic embryogenesis in conifers is a current focus of attention in many laboratories. Indra Vasil (University of Florida, Gainesville) showed that there were remarkable similarities with monocot angiosperms in the malleability of somatic embryo cultures and in the regenerative potential from protoplasts of somatic embryos. The accumulation of storage proteins in maturing somatic embryos reflects the process in seed (zygotic) embryos, an analysis by Inger Hakman (Institute of Physiological Botany, Uppsala) that will be helpful in assessing somatic embryo maturation prior to transplantation. Techniques developed for the cryopreservation of somatic embryos show that it is now possible to store valuable genetic stock, and to potentially explore cold tolerance criteria, according to Kutty Kartha (Plant Biotechnology Institute, National Research Council of Canada, Saskatoon). Researchers would find it useful to occasionally review the availability of potential regenerative tissues in source plants, and in this respect, John Owens (University of Victoria, British Columbia) discussed suitable target tissues and provided observations from his studies of vegetative and reproductive phenologies. Larry Fowke (University of Saskatchewan, Saskatoon) showed that the type of cultures now available (somatic embryos and protoplasts) lend themselves to investigations of the conifer cytoskeleton and cell walls, in a manner analogous to studies with other plant species.Basic studies on organelle inheritance and use of gene probes are being carried out, and genetic transformation research is still in its infancy. Ron Sederoff (North Carolina State University, Raleigh) felt that exciting results from such studies will probably be heard at the fifth meeting in Kent, England, in 1990. Finally, Maurice Moloney (University of Calgary, Alberta) anticipated that we may also then have answers to some of the remaining questions in conifer molecular biology, such as molecular evolution of genes; the role of introns, repeated sequences, and transpositions; the regulation of gene expression; and promoter function. Workshop topics during the meeting were markers of morphogenesis, economics of tissue culture propagation, phase change, and gene manipulation.The following papers, presented during the meeting are a reflection of some of the progress that is being made in conifer biotechnology research. The ICTCWG was formally renamed Conifer Biotechnology Work Group.

Abstract EWSR1, a member of the FET protein family, contains low complexity and nucleic acid binding domains and functions in transcription regulation and RNA metabolism. Recent biochemical and EWSR1-depletion studies demonstrated that EWSR1 regulates critical phosphorylation events that control basal transcription. In Ewing sarcoma (EWS) cells, the interaction of EWSR1 and the fusion oncoprotein EWS-FLI1 results in EWSR1 no longer functioning as an effective regulator of transcription, which following DNA damage, enhances R-loop formation. To further elucidate EWSR1’s function in EWS and its contribution to EWS-FLI1’s deregulation of gene expression, we have generated reporter systems to visualize and quantify its endogenous expression within EWS cells. We used CRISPR-Cas9 and sgRNAs targeting sequences at the 5’ end of the first exon of EWSR1 to insert a fluorescent mNeonGreen (mNG) reporter gene into the EWSR1 loci of A673 or TC-32 EWS cell lines. We employed sequencing and RNAi-based analysis to identify and validate successfully modified clones. All modified clones harbored insertions into the unrearranged EWSR1 allele. We then employed super-resolution confocal microscopy to assess EWSR1’s localization in EWS cells. Analysis of modified EWS-cells showed mNG-EWSR1 forms puncta, restricted to the nucleoplasm, consistent with a nuclear protein in an active state. A subset of puncta exhibits a high density (HD) mNG-EWSR1 signal, defined by fluorescence at least twice the background signal. Our results show minimal colocalization of mNG-EWSR1 (total or HD) and a marker of chromatin accessibility, H3K27Ac. A small percentage (~5%) of total Ser5-phosphorylated RNA-pol II (pS5-RP-II), a marker of transcription initiation, colocalizes with total mNG-EWSR1, but critically the HD mNG-EWSR1 puncta all colocalize with pS5-RP-II. About 20% of total Ser2-phosphorylated RNA-pol II (pS2-RP-II), a marker of transcription elongation colocalizes with total mNG-EWSR1. As observed for pS5-RP-II, 100% of HD-mNG-EWSR1 puncta colocalize with pS2-RP-II. Finally, when we examined nuclear speckle structures (SC35/SRSF2 &gt;200 µm), we observed a 20% overlap in their signals. We have seen comparable results using the mNG-EWSR1 expressing A673 cells. These findings demonstrate image-based quantification of endogenous EWSR1’s colocalization with RNA-polymerase II within EWS cells. Overall, EWSR1 colocalizes with about 20% of RNA-pol II in a state consistent with active transcription, and over 90% of high-density EWSR1 colocalizes with phosphorylated RNA pol II. Ongoing studies will assess changes in the distribution of EWSR1’s interactions with different proteins following inhibition of RNA-pol II phosphorylation, alterations in EWS-FLI1 expression, or the disruption of low complexity domain interactions. We anticipate findings from these studies will offer critical insights into the functional interactions that EWSR1 contributes to regulating gene expression in EWS cells. Citation Format: Natasha J. Caplen, Soumya Sundara Rajan, Vernon Ebegboni, Tamara L. Jones, Michael J. Kruhlak, Jan Wisniewski, Patricio Pichling, Katelyn R. Ludwig, Javed Khan, Raj Chari. Visualization of EWSR1’s colocalization with phosphorylated RNA-Polymerase II reveals its concentration at a subset of active regions of transcription in ewing sarcoma cells [abstract]. In: Proceedings of the AACR Special Conference: Sarcomas; 2022 May 9-12; Montreal, QC, Canada. Philadelphia (PA): AACR; Clin Cancer Res 2022;28(18_Suppl):Abstract nr B012.

Abstract Background Erythrocytosis / polycythemia is divided into primary and secondary. Primary polycythemia can be either acquired; i.e. polycythemia vera (PV) due to somatic JAK2 mutation, or congenital due to germ-line DNA changes (erythropoietin (EPO) receptor and VHL mutations in Chuvash polycythemia). These mutations are expressed within erythroid progenitors, drive increased erythropoiesis and are detected by hypersensitive or autonomous EPO BFU-E responses. In contrast, secondary erythrocytosis (SE), such as seen with cardiopulmonary pathologies, is driven by the circulating EPO. Chronic mountain sickness (CMS) is characterized by high altitude pathological erythrocytosis and by cognitive and neurological impairments. CMS is found in subjects living in high altitude (2500 meters and higher). In La Paz, Bolivia, (3600m) there is 7% incidence of CMS erythrocytosis. Some human populations (Tibetans, Andean Quechuas and Aymaras, and Ethiopians) are adapted to very high altitudes and their adapted phenotypes and, in some instances, evolutionarily selected haplotypes, have been reported. Whole genome was evaluated in Andeans and two genes, SENP1 and ANP32D were found to be evolutionarily selected and correlated with presence or absence of erythrocytosis. The genes down-regulation in hypoxia had survival benefit in Drosophila ortholog (1).SENP1 desumoylate GATA-1 and other regulatory proteins and is critical for definitive erythropoiesis (2,3). Here we evaluated native Aymara La Paz dwellers with three types of polycythemia: CMS, SE secondary to cardiopulmonary disease, and PV, by clinical studies and by in vitro evaluation of erythroid progenitors, and compared them to non-polycythemic subjects. Patients and Methods Complete blood count was performed by automatic hematologic counter (Micro 60, USA). Serum EPO was measured by Elisa (R&D System, USA) and JAK2V617F mutation analysis by PCR assay. Erythroid progenitors were isolated by density gradient centrifugation and cultured in methylcellulose medium with and without EPO (Stem Cell technologies, Canada) at 370 C and 5 % CO2. BFU-E colonies reading was carried out according to standardized criteria at 7 and 14 days. Results Table. Normal Control(n=10) CMS (n=15) Secondary Erythrocytosis(n=10) PolycythemiaVera (n=5) 1.Gender M/F 10/0 15/0 10/0 3/2 Age (range) 42 (40-47) 48 (29-58) 53 (34-72) 67 (42-74) Hb g/dl (SD) 16.2 (+ 0.9) 20.3 (+ 0.9) 22.8 (+ 1.4) 20.0 (+ 2.5) Ret % (SD) 1.3 (+ 0.1) 2.9 (+ 1.3) 3.6 (+ 1.2) 2.1 (+ 0.3) WBC /ul (SD) 6300 (+ 1600) 7200 (+ 1900) 6600 (+ 1700) 16600 (+ 4800) PLT 103 ul (SD) 273 (+ 80) 229 (+ 58) 193 (+ 54) 604 (+ 177) sEPO mUI/ml (SD) 10.0 (+ 3.9) 10.5 (+ 2.2) 82.9 (+ 30.4) 3.0 (+ 1.2) JAK2 V617F, No. (%) 0 (0) 0 (0) 0 (0) 100 Apoptosis Normal Delayed Normal Delayed BFU-E: EEC 0 (0-0) 10 (2-25) 0 (0-0) 45 (25-70) References: 1. Yu L et al. J Exp Med., 2010, 207:1183. 2. Sharma D et al. Cell Report, 2013, 3:1640. 3. Zhou D et al. Am J Hum Genet. 2013, 93:452. 4. Kapralova K et al. Blood. 2014,123:391 Conclusions a) Endogenous erythroid colony (EEC) are present in Aymaras with CMS, indicating primary polycythemia. b) Endogenous EECs are higher in PV than in CMS. c) CMS subjects have normal serum EPO levels. d) The role of SENP1, and hypoxia-regulated RUNX1 and NF-E2 (4) that promote erythropoiesis, is being interrogated in native erythroid cells. e) It remains to be determined if the autonomous BFU-E growth is specific for Aymara's CMS or present in CMS individuals of other ethnicities. Disclosures No relevant conflicts of interest to declare.

AbstractRising consumer concerns with synthetic drugs to treat non-communicable diseases (NCDs) have promoted a shift towards using natural biological active constituents that offer similar health benefits. Hairless canary seed (Phalaris canariensis L) is an emerging crop traditionally used in Mexico to treat NCDs. Peptides liberated during simulated digestion of canary seed protein are believed to be responsible for their biological activity; however, no studies have shown the effect of controlled protein hydrolysis using commercial proteases on canary seed protein’s biological activity. Therefore, this study aimed to explore the in vitro antihypertensive, antidiabetic, and anti-obesity activity of canary seed peptides derived from proteolysis with Alcalase®. Protein fractions were primarily composed of prolamins (54.07 ± 1.8%), glutelins (32.19 ± 3.18%), globulins (5.97 ± 0.52%) and albumins (5.97 ± 0.52%). The < 3 kDa and 3–10 kDa peptide fractions showed the highest inhibition capacity (p < 0.05) towards angiotensin-converting enzyme (IC50= 0.028–0.032 mg/mL) lipase (IC50= 2.15–2.27 mg/mL), α-glucosidase (IC50= 0.82–1.15 mg/mL), and dipeptidyl-peptidase-IV (IC50= 1.27–1.60 mg/mL). Additionally, these peptide fractions showed high antioxidant activity against DPPH (134.22–150.66 μmol TE/mg) and ABTS (520.92–813.33 μmol TE/mg). These results provide an insight into the potential development of functional foods using commercial enzymatic hydrolysis of canary seed proteins for treating hypertension, type-2 diabetes, and obesity.

Background: Chickpea is a widely grown legume in India, Australia, Canada, and Mediterranean regions. Seeds of chickpea are good source of protein for both human and animals. Wild relatives of chickpea (Cicer arietinum) are the potential gene pool for crop improvement; however, very little information is available on the seed proteome of these wild chickpeas. Objective: We aimed to analyze the seed proteome profiles of three wild relatives of chickpea, Cicer bijugum, Cicer judaicum and Cicer microphyllum along with two cultivated varieties JG11 and DCP 92/3. Method: Total seed proteins were extracted using various extraction buffers for 2-D gel electrophoresis. Protein separated in a 2-D gels were subjected to image analyses, differentially expressed proteins were extracted from the gels and identified by the MALDI TOF/TOF. Seed protease inhibitors were analysed biochemically. Results: We have standardized the 2-D gel electrophoresis method and separated seed proteins using the modified method. We identified a large number (400) of protein proteins which were differentially expressed in cultivated and wild type species of chickpea. A comparative analysis between C. bijugum and JG 11 revealed the presence of 9 over-expressed and 22 under-expressed proteins, while the comparison between C. bijugum with DCP 92/3 showed 8 over-expressed and 18 under-expressed proteins. Similarly, comparative analysis between C. microphyllum with DCP 92/3 showed 8 over-expressed proteins along with 22 under-expressed proteins, while the comparative study of C. microphyllum with JG11 displayed 9 over-expressed and 24 under-expressed proteins. We also compared C. judaicum with DCP 92/3 which revealed 15 overexpressed and 11 under-expressed proteins. On the other hand, the comparative analysis of C. judaicum with JG11 showed 10 over-expressed proteins, while the numbers of under-expressed proteins were 14. Among the differentially expressed protein proteins, 19 proteins were analyzed by the MS/MS, and peptides were identified using the MASCOT search engine. In teh wild relatives the differtially expressed proteins are phosphatidylinositol 4-phosphate 5- kinase, β-1-6 galactosyltransferase, RNA helicase, phenyl alanine ammonia lyase 2, flavone 3’-0-methyl transferase, Argonaute 2, Myb related protein, Tubulin beta-2 chain and others. The most important one was legumin having α- amylase inhibition activity which was up regulated in C. bijugum. We also studied the activity of protease inhibitor (trypsin and α- amylase inhibitors) in these seed lines which showed differential activity of protease inhibitors. The highest trypsin and α- amylase inhibition was observed in C. judaicum and C. bijugum, respectively. Conclusion: The differentially expressed proteins of wild relatives of chickpea appeared to be involved in various metabolic pathways. The study provides us information about the differences in the seed proteome of these wild species and cultivated varieties for the first time.

Plant-derived folates (Vitamin B9) are essential components of the human diet. They provide one-carbon units that are required for the synthesis of nucleic acids and proteins, and folate deficiency is associated with numerous adverse health conditions. The development of high-folate cultivars of common bean (Phaseolus vulgaris L.) and other staple crops is an important tool to combat folate deficiency. A population of 96 P. vulgaris accessions, representing major North American market classes, was grown in 2 years in Ontario, Canada. The population was genotyped for 5,361 molecular markers with an Illumina Infinium platform. Total folate was extracted from mature seeds using the tri-enzyme extraction method and quantified based on a microbiological assay with Lactobacillus rhamnosus. Significant genetic diversity for folate content was observed among the population in both years of study, and folate content had a range 113–222 μg per 100 g of seeds. Quantitative trait loci (QTL) for seed folate content were identified based on a genome-wide association study (GWAS). Six QTL were identified on Chr. 4, 6, 8, and 11, with three in each year of field trials. Both QTL on Chr. 11 occurred in genomic regions that were syntenic to seed folate QTL detected in previous work with P. vulgaris, Z. mays, and O. sativa. Candidate genes were identified for these QTL that might be targets for the development of molecular markers for selecting P. vulgaris cultivars with improved seed folate content. This work reports the largest survey of genetic diversity for seed folate content in P. vulgaris and identified several genotypes, including SCN4, Bat 93, OAC Redstar, and Pompadour 1014, that would be useful for breeding beans with higher than average folate levels.

AbstractFor the production of recombinant proteins, product purification is potentially difficult and expensive. Plant oleosins are capable of anchoring onto the surface of natural or artificial oil bodies. The oleosin fusion expression systems allow products to be extracted with oil bodies. In vivo, oleosin fusions are produced and directly localized to natural oil bodies in transgenic plant seeds. Via the oleosin fusion technology the thrombin inhibitor hirudin has been successfully produced and commercially used in Canada. In vitro, artificial oil bodies have been used as “carriers” for the recombinant proteins expressed in transformed microbes. In this article, plant oleosins, strategies and limitations of the oleosin fusion expression systems are summarized, alongside with progress and applications. The oleosin fusion expression systems reveal an available way to produce recombinant biopharmaceuticals at large scale.

Abstract The complete genome sequence of a novel circovirus (elk circovirus (ElkCV) Banff/2019) was determined via high throughput sequencing of liver tissue from a euthanized Rocky Mountain elk (Cervus canadensis nelsoni) from Alberta, Canada. The genome is circular and 1,787 nucleotides long, with two major ORFs encoding predicted proteins. Comparative genomic analysis to 4,164 publicly available complete and near complete circovirus genomes showed that ElkCV shares approximately 65% pairwise genome-wide nucleotide identity with the most closely related circovirus species, porcine circoviruses (PCV) 1 and 2 and bat-associated circovirus (BatACV) 11. ElkCV features a stem-loop within the origin of replication region characteristic of circoviruses. However, it differs from those found in PCV1, PCV2 and BatACV11 since it has a longer stem and contains hexamer repeats that overlap the stem in opposing orientations. Interestingly, stem-loop structures of similar length featuring repeats in a similar position and orientation are also seen in some avian circoviruses. Based on the demarcation threshold established by the International Committee on Taxonomy of Viruses (ICTV) for members of Circoviridae (80% pairwise genome-wide nucleotide identity), ElkCV represents a novel species and is the first complete circovirus genome reported from a cervid host.

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) has requested the Norwegian Food Safety Authority (NFSA) to give final opinions on all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC within the Authority’s sectoral responsibility. The Norwegian Food Safety Authority has therefore, by letter dated 13 February 2013 (ref. 2012/150202), requested the Norwegian Scientific Committee for Food Safety (VKM) to carry out scientific risk assessments of 39 GMOs and products containing or consisting of GMOs that are authorized in the European Union. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. The assignment includes a scientific risk assessment of oilseed rape T45 from Bayer Crop Science (Unique Identfier ACS-BNØØ8-2) for food and feed uses, import and processing. Food additives produced from T45 oilseed rape were notified in the EU as existing food additives within the meaning of Article 8 (1) (b) of Regulation 1829/2003, authorized under Directive 89/10/EEC (Community Register 2005). Feed materials produced from T45 were also notified as existing feed products containing, consisting of or produced from T45 according to Articles 8 and 20 of Regulation (EC) No 1829/2003 in 2003. A notification for placing on the market of T45 according to the Directive 2001/18/EC was submitted in March 2004 (C/GB/04/M5/4), covering import and processing of T45 into food and feed. The application was further transferred into Regulation (EC) No 1829/2003 in November 2005 (EFSA/GMO/UK/2005/25). An application for renewal of authorisation for continued marketing of food additives and feed materials produced from T45 oilseed rape was submitted under Regulation (EC) No 1829/2003 in 2007 (EFSA/GMO/RX/T45). The EFSA GMO Panel performed one single comprehensive risk assessment for all intended uses of genetically modified oilseed rape T45 and issued a comprehensive scientific opinion for both applications submitted under Regulation (EC) No 1829/2003. The scientific opinion was published in January 30 2008 (EFSA 2008), and food and feed products containing or produced from oilseed rape T45 was approved by Commission Decision 26 March 2009 (Commission Decision 2009/184/EC). The oilseed rape T45 is however currently being phased out (EU-COM 2009). The commercialisation of T45 oilseed rape seeds in third countries was stopped after the 2005 planting season and stocks of all oilseed rape T45 lines have been recalled from distribution and destroyed. The applicant commits not to commercialize the event in the future and the import will therefore be restricted to adventitious levels in oilseed rape commodity. Thus the incidence of oilseed rape T45 in the EU is expected to be limited. Oilseed rape T45 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMO), commissioned by the NFSA related to the EFSAs public hearing in 2007 (VKM 2007a). The risk assessment of the oilseed rape T45 is based on information provided by the notifier in the application EFSA/GMO/UK/2005/25 and EFSA/GMO/RX/T45, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated T45 with reference to its intended uses in the European Economic Area (EEA) and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010) and the selection of comparators for the risk assessment of GM plants (EFSA 2011b). The scientific risk assessment of oilseed rape T45 include molecular characterisation of the inserted DNA and expression of novel proteins, comparative assessment of agronomic and phenotypic characteristics, comparative compositional analysis, food/feed safety assessments and environmental assessment. It is emphasized that the VKM mandate does not include assessments of contribution to sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act. These considerations are therefore not part of the risk assessment provided by the VKM Panel on Genetically Modified Organisms. The glufosinate ammonium-tolerant oilseed rape transformation event T45 was developed by Agrobacterium-mediated transformation of protoplast from the conventional oilseed rape cultivar “AC Excel”. T45 contains a synthetic version of the native pat gene isolated from the bacteria Streptomyces viridochromogenes, strain Tü 494. The inserted gene encodes the enzyme phosphinothricin acetyltransferase (PAT), which confers tolerance to the herbical active substance glufosinate ammonium. The PAT enzyme detoxifies glufosinate-ammonium by acetylation of the L-isomer into N-acetyl-L-glufosinate ammonium (NAG) which does not inhibit glutamine synthetase and, therefore, confers tolerance to the herbicide. Glufosinate ammonium-tolerant oilseed rape transformation event T45 has been conventionally bred into an array of spring-type oilseed rape varieties. Molecular characterization: The molecular characterisation data established that only one copy of the gene cassette is integrated in the oilseed rape genomic DNA. Appropriate analysis of the integration site including sequence determination of the inserted DNA and flanking regions, and bioinformatics analysis have been performed. Bioinformatics analyses of junction regions demonstrated the absence of any potential new ORFs coding for known toxins or allergens. The genetic stability of transformation event T45 was demonstrated at the genomic level over multiple generations by Southern analysis. Segregation analysis shows that event T45 is inherited as dominant, single locus trait. Phenotypic stability has been confirmed by stable tolerance to the herbicide for T45 lines and varieties derived from the event grown in Canada since 1993. Oilseed rape transformation event T45 and the physical, chemical and functional characteristics of the proteins have previously been evaluated by The VKM Panel on Genetically Modified Organisms, and considered satisfactory (VKM 2007a). Comparative assessment: For compositional analysis seeds were harvested from three field trials performed in Canada (1995, 2000 and 2004). These field trials were conducted using agronomic practices and field conditions typical of commercial oilseed rape cultivation and provided environmental situations representative of the geographical regions oilseed rape will be grown. The analytical data were statistically evaluated by analysis of difference between T45 oilseed rape and its non-transgenic parent variety AC Excel or to other comparators, derived from AC Excel. Several of the components listed in OECDs consensus document (OECD 2011) concerning oilseed rape have not been analyzed in seed, oil or meal such as vitamin K and the antinutrient sinapine. Compositional analysis was carried out with respect to proximates, fibers, amino acids, vitamin E (alfa-, beta, gamma- and delta tocopherol, total tocopherol, minerals (phosphorus, iron, calcium, sodium, copper, magnesium, manganese, potassium and zinc), fatty acids, phytic acid and glucosinolates (alken glucosin, MSGL glucosin and indole glucosinolates). The PAT protein was detected by ELISA only in trace amounts in toasted meal from T45 oilseed rape and not detected in blended, degummed, refined, bleached and deodorized oil. The compositional analysis showed statistical differences for some of the analyzed components. However, this is not considered biological relevant because it is within the reference range from the literature. Based on results from comparative analyses of data from field trials located at representative sites and environments in Canada in 1995-1997, it is concluded that oilseed rape T45 is agronomically and phenotypically equivalent to the conventional counterpart and commercial available reference varieties, with the exception of maturity and the herbicide tolerance conferred by the PAT protein. The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of event T45 compared to conventional oilseed rape. Furthermore, the results demonstrate that in-crop applications of glufosinate herbicide do not alter the phenotypic and agronomic characteristics of event T45 compared to conventional oilseed rape. Food and feed safety assessment: The total amino acid sequence of the PAT protein was compared to that of known toxins and allergens listed in public databases. Based on these results, no evidence for any similarity to known toxic or allergenic proteins was found. An animal feeding study was performed in broiler chickens. This study showed no indications that neither the event T45 treated with glufosinate ammonium nor untreated, has adverse effects on feeding, growth or general health. To test the case of an acute exposure of the PAT protein to the circulatory system, an acute intravenous study was conducted in mice with highly purified (>95%) PAT protein, encoded by the pat gene (produced in E. coli). PAT protein, aprotinin (negative control) or melittin (positive control) were administered at dose levels of 1 and 10 mg/kg body weight. After 15 days the animals treated with the PAT protein and aprotinin at 10 mg/kg had no visible signs of systemic toxicity, in contrast to melittin which induced 100% mortality within 5 minutes at the same dose. Macroscopic examination of internal organs showed no signs of acute toxicity following treatment with PAT protein. Environmental risk: According to the applicant, the event T45 has been phased out, and stocks of all oilseed rape T45 lines have been recalled from distribution and destroyed since 2005. However, since future cultivation and import of oilseed rape T45 into the EU/EEA area cannot be entirely ruled out, the environmental risk assessment consider exposure of viable seeds of T45 through accidental spillage into the environment during transportation, storage, handling, processing and use of derived products. Oilseed rape is mainly a self-pollinating species, but has entomophilous flowers capable of both self- and cross-pollinating. Normally the level of outcrossing is about 30%, but outcrossing frequencies up to 55% are reported. Several plant species related to oilseed rape that are either cultivated, occurs as weeds of cultivated and disturbed lands, or grow outside cultivation areas to which gene introgression from oilseed rape could be of concern. These are found both in the Brassica species complex and in related genera. A series of controlled crosses between oilseed rape and related taxa have been reported in the scientific literature. Because of a mismatch in the chromosome numbers most hybrids have a severely reduced fertility. Exceptions are hybrids obtained from crosses between oilseed rape and wild turnip (B. rapa ssp. campestris) and to a lesser extent, mustard greens (B. juncea), where spontaneously hybridising and transgene introgression under field conditions have been confirmed. Wild turnip is native to Norway and a common weed in arable lowlands. There is no evidence that the herbicide tolerant trait results in enhanced fitness, persistence or invasiveness of oilseed rape T45, or hybridizing wild relatives, compared to conventional oilseed rape varieties, unless the plants are exposed to herbicides with the active substance glufosinate ammonium. Glufosinate ammonium-containing herbicides have been withdrawn from the Norwegian market since 2008, and the substance will be phased out in the EU in 2017 for reasons of reproductive toxicity. Accidental spillage and loss of viable seeds of T45 during transport, storage, handling in the environment and processing into derived products is, however, likely to take place over time and the establishment of small populations of oilseed rape T45 cannot be excluded. Feral oilseed rape T45 arising from spilled seed could theoretically pollinate conventional crop plants if the escaped populations are immediately adjacent to field crops and shed seeds from cross-pollinated crop plants could emerge as GM volunteers in subsequent crops. However, both the occurrence of feral oilseed rape resulting from seed import spills and the introgression of genetic material from feral oilseed rape populations to wild populations are likely to be low in an import scenario. Apart from the glufosinate tolerance trait, the resulting progeny will not possess a higher fitness and will not be different from progeny arising from cross-fertilisation with conventional oilseed rape varieties. The VKM GMO Panel The occurrence of feral oilseed rape resulting from seed import spills and the introgression of genetic material from feral oilseed rape populations to wild populations are likely to be low in an import scenario in Norway. Overall conclusion: The VKM GMO Panel concludes that T45 oilseed rape, based on current knowledge, is comparable to conventional oilseed rape varieties concerning health risks with the intended usage. The GMO Panel likewise concludes that T45 is unlikely to have any adverse effect on the environment and agriculture in Norway in the context of its intended usage.

The environmental risk assessment of the herbicide tolerant genetically modified oilseed rape MON 88302 (Reference EFSA/GMO/BE/2011/101) has been performed by the Panel on Genetically Modified Organisms (GMO) of the Norwegian Scientific Committee for Food Safety (VKM). VKM has been requested by the Norwegian Directorate for Nature Management and the Norwegian Food Safety Authority to issue a preliminary scientific opinion on the safety of the genetically modified oilseed rape MON 88302 (Unique identifier MON-88Ø2-9) for food and feed uses, import and processing, and submit relevant scientific comments or questions to EFSA on the application EFSA/GMOBE/2011/101. The environmental risk assessment of the MON 88302 is based on information provided by the applicant in the application EFSA/GMO/BE/2011/101, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated MON 88302 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010), the selection of comparators for the risk assessment of GM plants (EFSA 2011b), and for the post-market environmental monitoring of GM plants (EFSA 2006, 2011c). The scientific risk assessment of oilseed rape MON 88302 include molecular characterisation of the inserted DNA and expression of target proteins, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness, potential for horizontal and vertical gene transfer, and evaluations of the post-market environmental plan. In line with its mandate, VKM emphasized that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms. The GMO Panel has therefore not considered possible health and environmental effects of cultivation and processing of oilseed rape MON 88302 outside the EU/EEA area. The genetically modified oilseed rape MON 88302 was developed to provide tolerance to the herbical active substance glyphosate by the introduction of a gene coding for the enzyme 5enolpyruvylshikimate-3-phosphate synthase (EPSPS) from Agrobacterium tumefaciens, strain CP4 (CP4 EPSPS). Glyphosate is a non-selective herbicide and is normally phytotoxic to a broad range of plants. Its mode of action occurs by binding to and inactivating the EPSPS protein, which is a key enzyme in the shikimate pathway that leads to the biosynthesis of the aromatic amino acids tyrosine, tryptophan and phenylalanine. The disruption of this pathway and the resulting inability to produce key amino acids prevents growth and ultimately leads to plant death. Molecular characterization: The VKM Panel on Genetically Modified Organisms find the conclusion that no major section of the T-DNA plasmid backbone is inserted in MON88302 oilseed rape justified. We also find it justified that there is only one major T-DNA insert in MON88302. Comparative assessment: Based on results from comparative analyses of data from field trials located at representative sites and environments in the USA, Canada and Chile, it is concluded that oilseed rape MON 88302 is agronomically and phenotypically equivalent to the conventional counterpart and commercial available reference varieties, with the exception of the herbicide tolerance conferred by the CP4 EPSPS protein. The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of MON 88302 compared to conventional oilseed rape. Furthermore, the results demonstrate that in-crop applications of glyphosate herbicide do not alter the phenotypic and agronomic characteristics of MON 88302 compared to conventional oilseed rape. Evaluations of environmental interactions between genetically modified oilseed rape MON 88302 and the biotic and abiotic environment, and studies of seed dormancy, seed germination, pollen morphology and viability indicates no unintended effects of the introduced trait on these characteristics in MON 88302 oilseed rape. Environmental risk: Considering the scope of the application EFSA/GMO/BE/2011/101, excluding cultivation purposes, the environmental risk assessment is limited to exposure through accidental spillage of viable seeds of MON 88302 into the environment during transportation, storage, handling, processing and use of derived products. Oilseed rape is mainly a self-pollinating species, but has entomophilous flowers capable of both self- and cross-pollinating. Normally the level of outcrossing is about 30 %, but outcrossing frequencies up to 55 % are reported. Several plant species related to oilseed rape that are either cultivated, occurs as weeds of cultivated and disturbed lands, or grow outside cultivation areas to which gene introgression from oilseed rape could be of concern. These are found both in the Brassica species complex and in related genera. A series of controlled crosses between oilseed rape and related taxa have been reported in the scientific literature. Because of a mismatch in the chromosome numbers most hybrids have a severely reduced fertility. Exceptions are hybrids obtained from crosses between oilseed rape and wild turnip (B. rapa ssp. campestris) and to a lesser extent, mustard greens (B.juncea), where spontaneously hybridising and transgene introgression under field conditions have been confirmed. Wild turnip is native to Norway and a common weed in arable lowlands. There is no evidence that the herbicide tolerant trait results in enhanced fitness, persistence or invasiveness of oilseed rape MON 88302, or hybridizing wild relatives, compared to conventional oilseed rape varieties, unless the plants are exposed to glyphosate-containing herbicides. However, accidental spillage and loss of viable seeds of MON 88302 during transport, storage, handling in the environment and processing into derived products is likely to take place over time, and the establishment of small populations of oilseed rape MON 88302 on locations where glyphosate is frequently applied to control weeds e.g. on railway tracks, cannot be excluded. Feral oilseed rape MON 88302 arising from spilled seed could theoretically pollinate conventional crop plants if the escaped populations are immediately adjacent to field crops, and shed seeds from cross-pollinated crop plants could emerge as GM volunteers in subsequent crops. However, both the occurrence of feral oilseed rape resulting from seed import spills and the introgression of genetic material from feral oilseed rape populations to wild populations are likely to be low in an import scenario. Apart from the glyphosate tolerance trait, the resulting progeny will not possess a higher fitness and will not be different from progeny arising from cross-fertilisation with conventional oilseed rape varieties. The VKM GMO Panel concludes that this route of gene flow would not introduce significant numbers of transgenic plants into agricultural areas or result in any environmental consequences in Norway. The environmental risk assessment will be completed and finalized by the VKM Panel on Genetically Modified Organisms when requested additional information from the applicant is available.

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Directorate for Nature Management to conduct final environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. The assignment includes a scientific environmental risk assessment of oilseed rape T45 (Reference EFSA/GMO/UK/2005/25) from Bayer CropScience for food and feed uses, import and processing. Oilseed rape T45 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMO), commissioned by the Norwegian Food Safety Authority related to the EFSAs public hearing in 2007 (VKM 2007a). Food additives produced from T45 oilseed rape were notified in the EU as existing food additives within the meaning of Article 8 (1)(b) of Regulation 1829/2003, authorized under Directive 89/10/EEC (Community Register 2005). Feed materials produced from T45 were also notified as existing feed products containing, consisting of or produced from T45 according to Articles 8 and 20 of Regulation (EC) No 1829/2003 in 2003. A notification for placing on the market of T45 according to the Directive 2001/18/EC was submitted in March 2004 (C/GB/04/M5/4), covering import and processing of T45 into food and feed. The application was further transferred into Regulation (EC) No 1829/2003 in November 2005 (EFSA/GMO/UK/2005/25). An application for renewal of authorisation for continued marketing of food additives and feed materials produced from T45 oilseed rape was submitted under Regulation (EC) No 1829/2003 in 2007 (EFSA/GMO/RX/T45). The EFSA GMO Panel performed one single comprehensive risk assessment for all intended uses of genetically modified oilseed rape T45, and issued a comprehensive scientific opinion for both applications submitted under Regulation (EC) No 1829/2003. The scientific opinion was published in January 30 2008 (EFSA 2008), and food and feed products containing or produced from oilseed rape T45 was approved by Commission Decision 26 March 2009 (Commission Decision 2009/184/EC). The oilseed rape T45 is however currently being phased out (EU-COM 2009). The commercialisation of T45 oilseed rape seeds in third countries was stopped after the 2005 planting season and stocks of all oilseed rape T45 lines have been recalled from distribution and destroyed. The applicant commits not to commercialize the event in the future and the import will therefore be restricted to adventitious levels in oilseed rape commodity. Thus the incidence of oilseed rape T45 in the EU is expected to be limited. The environmental risk assessment of the oilseed rape T45 is based on information provided by the notifier in the application EFSA/GMO/UK/2005/25 and EFSA/GMO/RX/T45, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated T45 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010), the selection of comparators for the risk assessment of GM plants (EFSA 2011b), and for the post-market environmental monitoring of GM plants (EFSA 2006, 2011c). The scientific risk assessment of oilseed rape T45 include molecular characterisation of the inserted DNA and expression of target proteins, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness, potential for horizontal and vertical gene transfer, and evaluations of the post-market environmental plan. In line with its mandate, VKM emphasised that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms. The glufosinate ammonium-tolerant oilseed rape transformation event T45 (Unique Identfier ACSBNØØ8-2) was developed by Agrobacterium-mediated transformation of protoplast from the conventional oilseed rape cultivar “AC Excel”. T45 contains a synthetic version of the native pat gene isolated from the bacteria Streptomyces viridochromogenes, strain Tü 494. The inserted gene encodes the enzyme phosphinothricin acetyltransferase (PAT), which confers tolerance to the herbical active substance glufosinate ammonium. The PAT enzyme detoxifies glufosinate-ammonium by acetylation of the L-isomer into N-acetyl-L-glufosinate ammonium (NAG) which does not inhibit glutamine synthetase and therefore confers tolerance to the herbicide. Glufosinate ammonium-tolerant oilseed rape transformation event T45 has been conventionally bred into an array of spring-type oilseed rape varieties. Molecular characterization: The molecular characterisation data established that only one copy of the gene cassette is integrated in the oilseed rape genomic DNA. Appropriate analysis of the integration site including sequence determination of the inserted DNA and flanking regions and bioinformatics analysis have been performed. Bioinformatics analyses of junction regions demonstrated the absence of any potential new ORFs coding for known toxins or allergens. The genetic stability of transformation event T45 was demonstrated at the genomic level over multiple generations by Southern analysis. Segregation analysis shows that event T45 is inherited as dominant, single locus trait. Phenotypic stability has been confirmed by stable tolerance to the herbicide for T45 lines and varieties derived from the event grown in Canada since 1993. Oilseed rape transformation event T45 and the physical, chemical and functional characteristics of the proteins have previously been evaluated by The VKM Panel on Genetically Modified Organisms, and considered satisfactory (VKM 2007a). Comparative assessment: Based on results from comparative analyses of data from field trials located at representative sites and environments in Canada in 1995-1997, it is concluded that oilseed rape T45 is agronomically and phenotypically equivalent to the conventional counterpart and commercial available reference varieties, with the exception of maturity and the herbicide tolerance conferred by the PAT protein. The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of event T45 compared to conventional oilseed rape. Furthermore, the results demonstrate that in-crop applications of glufosinate herbicide do not alter the phenotypic and agronomic characteristics of event T45 compared to conventional oilseed rape. Environmental risk: According to the applicant, the event T45 has been phased out, and stocks of all oilseed rape T45 lines have been recalled from distribution and destroyed since 2005. However, since future cultivation and import of oilseed rape T45 into the EU/EEA area cannot be entirely ruled out, the environmental risk assessment consider exposure of viable seeds of T45 through accidental spillage into the environment during transportation, storage, handling, processing and use of derived products. Oilseed rape is mainly a self-pollinating species, but has entomophilous flowers capable of both self- and cross-pollinating. Normally the level of outcrossing is about 30%, but outcrossing frequencies up to 55% are reported. Several plant species related to oilseed rape that are either cultivated, occurs as weeds of cultivated and disturbed lands, or grow outside cultivation areas to which gene introgression from oilseed rape could be of concern. These are found both in the Brassica species complex and in related genera. A series of controlled crosses between oilseed rape and related taxa have been reported in the scientific literature. Because of a mismatch in the chromosome numbers most hybrids have a severely reduced fertility. Exceptions are hybrids obtained from crosses between oilseed rape and wild turnip (B. rapa ssp. campestris) and to a lesser extent, mustard greens (B. juncea), where spontaneously hybridising and transgene introgression under field conditions have been confirmed. Wild turnip is native to Norway and a common weed in arable lowlands. There is no evidence that the herbicide tolerant trait results in enhanced fitness, persistence or invasiveness of oilseed rape T45, or hybridizing wild relatives, compared to conventional oilseed rape varieties, unless the plants are exposed to herbicides with the active substance glufosinate ammonium. Glufosinate ammonium-containing herbicides have been withdrawn from the Norwegian market since 2008, and the substance will be phased out in the EU in 2017 for reasons of reproductive toxicity. Accidental spillage and loss of viable seeds of T45 during transport, storage, handling in the environment and processing into derived products is, however, likely to take place over time, and the establishment of small populations of oilseed rape T45 cannot be excluded. Feral oilseed rape T45 arising from spilled seed could theoretically pollinate conventional crop plants if the escaped populations are immediately adjacent to field crops, and shed seeds from cross-pollinated crop plants could emerge as GM volunteers in subsequent crops. However, both the occurrence of feral oilseed rape resulting from seed import spills and the introgression of genetic material from feral oilseed rape populations to wild populations are likely to be low in an import scenario. Apart from the glufosinate tolerance trait, the resulting progeny will not possess a higher fitness and will not be different from progeny arising from cross-fertilisation with conventional oilseed rape varieties. The occurrence of feral oilseed rape resulting from seed import spills and the introgression of genetic material from feral oilseed rape populations to wild populations are likely to be low in an import scenario in Norway. Overall conclusion: Taking into account the expected limited import of oilseed rape T45 (EU COM 2009), the VKM GMO Panel considers that the routes of gene flow from T45 would not introduce significant numbers of transgenic plants into agricultural areas or result in any environmental consequences in Norway. The VKM GMO Panel concludes that oilseed rape T45 is unlikely to have any adverse effect on the environment in Norway in the context of its intended usage.

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Directorate for Nature Management to conduct final environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Directorate requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. The genetically modified, glufosinate-tolerant oilseed rape lines MS8, RF3 and MS8 x RF3 (Notification C/BE/96/01) are approved under Directive 2001/18/EC for import and processing for feed and industrial purposes since 26 March 2007 (Commission Decision 2007/232/EC). In addition, processed oil from genetically modified oilseed rape derived from MS8, RF3 and MS8 x RF3 were notified as existing food according to Art. 5 of Regulation (EC) No 258/97 on novel foods and novel food ingredients in November 1999. Existing feed and feed products containing, consisting of or produced from MS8, RF3 and MS8 x RF3 were notified according to Articles 8 and 20 of Regulation (EC) No 1829/2003 and were placed on the market in January 2000. An application for renewal of the authorisation for continued marketing of existing food, food ingredients and feed materials produced from MS8, RF3 and MS8 x RF3 was submitted within the framework of Regulation (EC) No 1829/2003 in June 2007 (EFSA/GMO/RX/MS8/RF3). In addition, an application covering food containing or consisting of, and food produced from or containing ingredients produced from oilseed rape MS8, RF3 and MS8 x RF3 (with the exception of processed oil) was delivered by Bayer CropScience in June 2010 (EFSA/GMO/BE/2010/81). The VKM GMO Panel has previously issued a scientific opinion related to the notification C/BE/96/01 for the placing on the market of the oilseed rape lines for import, processing and feed uses (VKM 2008). The health and environmental risk assessment was commissioned by the Norwegian Directorate for Nature Management in connection with the national finalisation of the procedure of the notification C/BE/96/01 in 2008. Due to the publication of updated guidelines for environmental risk assessments of genetically modified plants and new scientific literature, the VKM GMO Panel has decided to deliver an updated environmental risk assessment of oilseed rape MS8, RF3 and MS8 x RF3. A scientific opinion on an application for the placing on the market of MS8/RF3 for food containing or consisting of, and food produced from or containing ingredients produced from MS8/RF3 (with the exception of processed oil) (EFSA/GMO/BE/2010/81) have also been submitted by the VKM GMO Panel (VKM 2012). The environmental risk assessment of the oilseed rape MS8, RF3 and MS8 x RF3 is based on information provided by the notifier in the applications EFSA/GMO/RX/MS8/RF3, EFSA/GMO/BE/2010/8, the notification C/BE/96/01, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated MS8, RF3 and MS8 x RF3 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010), the selection of comparators for the risk assessment of GM plants (EFSA 2011b), and for the post-market environmental monitoring of GM plants (EFSA 2006, 2011c). The scientific risk assessment of oilseed rape MS8, RF3 and MS8 x RF3 include molecular characterisation of the inserted DNA and expression of target proteins, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness, potential for horizontal and vertical gene transfer, and evaluations of the post-market environmental plan. In line with its mandate, VKM emphasised that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms. The genetically modified oilseed rape lines MS8 and RF3 were developed to provide a pollination control system for production of F1-hybrid seeds (MS8 x RF3). Oilseed rape is a crop capable of undergoing both self-pollination (70%) as well as cross-pollination (30%). Therefore a system to ensure only cross-pollination is required for producing hybrids from two distinct parents. As a result of hybrid vigor cross-pollinated plants produce higher yield as compared to self-pollinating rape. The hybrid system is achieved using a pollination control system by insertion and expression of barnase and barstar genes derived from the soil bacterium Bacillus amyloliquefaciens into two separate transgenic oilseed rape lines. The barnase gene in the male sterile line MS8 encode a ribonuclease peptide (RNase), expressed in the tapetum cells during anther development. The RNase effect RNA levels, disrupting normal cell function, arresting early anther development, and results in the lack of viable pollen and male sterility. The fertility restoration line RF3 contains a barstar gene, coding for a ribonuclease inhibitor (Barstar peptide) expressed only in the tapetum cells of the pollen during anther development. The peptide specifically inhibits the Barnase RNase expressed by the MS8 line. The RNase and the ribonuclease inhibitor form a stable one-to-one complex, in which the RNase is inactivated. As a result, when pollen from the receptor line RF3 is crossed to the male sterile line MS8, the MS8 x RF3 progeny expresses the RNase inhibitor in the tapetum cells of the anthers allowing hybrid plants to develop normal anthers and restore fertility. The barnase and barstar genes in MS8 and RF3 are each linked with the bar gene from Streptomyces hygroscopus. The bar gene is driven by a plant promoter that is active in all green tissues of the plant, and encodes the enzyme phosphinothricin acetyltransferase (PAT). The PAT enzyme inactivates phosphinothricin (PPT), the active constituent of the non-selective herbicide glufosinate-ammonium. The bar gen were transferred to the oilseed rape plants as markers both for use during in vitro selection and as a breeding selection tool in seed production. Molecular characterization: The oilseed rape hybrid MS8xRF3 is produced by conventional crossing. The parental lines MS8 and RF3 are well described in the documentation provided by the applicant, and a number of publications support their data. It seems likely that MS8 contains a complete copy of the desired T-DNA construct including the bar and barnase genes. Likewise, the event RF3 is likely to contain complete copies of the bar and barstar genes in addition to a second incomplete non-functional copy of the bar-gene. The inserts in the single events are preserved in the hybrid MS8xRF3, and the desired traits are stably inherited over generations. Oilseed rape MS8, RF3 and MS8xRF3 and the physical, chemical and functional characteristics of the newly expressed proteins have previously been evaluated by the VKM Panel on Genetically Modified Organisms, and considered satisfactory (VKM 2008, 2012). The GMO Panel finds the characterisation of the physical, chemical and functional properties of the recombinant inserts in the oilseed rape transformation events MS8, RF3 and MS8xRF3 to be satisfactory. The GMO Panel has not identified any novel risks associated with the modified plants based on the molecular characterisation of the inserts. Comparative assessment: Based on results from comparative analyses of data from field trials located at representative sites and environments in Europe and Canada, it is concluded that oilseed rape MS8, RF3 and MS8 x RF3 is agronomically and phenotypically equivalent to the conventional counterpart, except for the newly expressed barnase, barstar and PAT proteins. The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of event MS8, RF3 and MS8 x RF3 compared to conventional oilseed rape. Furthermore, the results demonstrate that in-crop applications of glufosinate herbicide do not alter the phenotypic and agronomic characteristics of event MS8, RF3 and MS8 x RF3 compared to conventional oilseed rape varieties. Environmental risk: Considering the scope of the notification C/BE/96/01, excluding cultivation purposes, the environmental risk assessment is limited to exposure through accidental spillage of viable seeds of MS8, RF3 and MS8 x RF3 into the environment during transportation, storage, handling, processing and use of derived products. Oilseed rape is mainly a self-pollinating species, but has entomophilous flowers capable of both self- and cross-pollinating. Normally the level of outcrossing is about 30%, but outcrossing frequencies up to 55% are reported. Several plant species related to oilseed rape that are either cultivated, occurs as weeds of cultivated and disturbed lands, or grow outside cultivation areas to which gene introgression from oilseed rape could be of concern. These are found both in the Brassica species complex and in related genera. A series of controlled crosses between oilseed rape and related taxa have been reported in the scientific literature. Because of a mismatch in the chromosome numbers most hybrids have a severely reduced fertility. Exceptions are hybrids obtained from crosses between oilseed rape and wild turnip (B. rapa ssp. campestris) and to a lesser extent, mustard greens (B. juncea), where spontaneously hybridising and transgene introgression under field conditions have been confirmed. Wild turnip is native to Norway and a common weed in arable lowlands. Accidental spillage and loss of viable seeds of MS8, RF3 and MS8 x RF3 during transport, storage, handling in the environment and processing into derived products is likely to take place over time, and the establishment of small populations of oilseed rape MS8, RF3 and MS8 x RF3 cannot be excluded. Feral oilseed rape MS8, RF3 and MS8 x RF3 arising from spilled seed could theoretically pollinate conventional crop plants if the escaped populations are immediately adjacent to field crops, and shed seeds from cross-pollinated crop plants could emerge as GM volunteers in subsequent crops. However, both the occurrence of feral oilseed rape resulting from seed import spills and the introgression of genetic material from feral oilseed rape populations to wild populations are likely to be low in an import scenario in Norway. There is no evidence that the herbicide tolerant trait results in enhanced fitness, persistence or invasiveness of oilseed rape MS8, RF3 and MS8 x RF3, or hybridizing wild relatives, compared to conventional oilseed rape varieties, unless the plants are exposed to herbicides with the active substance glufosinate ammonium. Apart from the glufosinate tolerance trait, the resulting progeny will not possess a higher fitness and will not be different from progeny arising from cross-fertilisation with conventional oilseed rape varieties. Glufosinate ammonium-containing herbicides have been withdrawn from the Norwegian market since 2008, and the substance will be phased out in the EU in 2017 for reasons of reproductive toxicity. Overall conclusion: The VKM GMO Panel concludes that oilseed rape MS8, RF3 and MS8xRF3 are unlikely to have any adverse effect on the environment in Norway in the context of its intended usage.

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) has requested the Norwegian Food Safety Authority (NFSA) to give final opinions on all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC within the Authority’s sectoral responsibility. The Norwegian Food Safety Authority has therefore, by letter dated 13 February 2013 (ref. 2012/150202), requested the Norwegian Scientific Committee for Food Safety (VKM) to carry out scientific risk assessments of 39 GMOs and products containing or consisting of GMOs that are authorized in the European Union. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. The genetically modified, glufosinate-tolerant oilseed rape lines MS8, RF3 and MS8 x RF3 (Notification C/BE/96/01) are approved under Directive 2001/18/EC for import and processing, for feed and industrial purposes since 26 March 2007 (Commission Decision 2007/232/EC). In addition, processed oil from genetically modified oilseed rape derived from MS8, RF3 and MS8 x RF3 were notified as existing food according to Art. 5 of Regulation (EC) No 258/97 on novel foods and novel food ingredients in November 1999. Existing feed and feed products containing, consisting of or produced from MS8, RF3 and MS8 x RF3 were notified according to Articles 8 and 20 of Regulation (EC) No 1829/2003 and were placed on the market in January 2000. An application for renewal of the authorisation for continued marketing of existing food, food ingredients and feed materials produced from MS8, RF3 and MS8 x RF3 was submitted within the framework of Regulation (EC) No 1829/2003 in June 2007 (EFSA/GMO/RX/MS8/RF3). In addition, an application covering food containing or consisting of, and food produced from or containing ingredients produced from oilseed rape MS8, RF3 and MS8 x RF3 (with the exception of processed oil) was delivered by Bayer CropScience in June 2010 (EFSA/GMO/BE/2010/81). The VKM GMO Panel has previously issued a scientific opinion related to the notification C/BE/96/01 for the placing on the market of the oilseed rape lines for import, processing and feed uses (VKM 2008). The food/feed and environmental risk assessment was commissioned by the Norwegian Environment Agency in connection with the national finalisation of the procedure of the notification C/BE/96/01 in 2008. Due to the publication of updated guidelines for risk assessments of genetically modified plants and new scientific literature, the VKM GMO Panel has decided to deliver an updated food, feed and environmental risk assessment of oilseed rape MS8, RF3 and MS8 x RF3. A scientific opinion on an application for the placing on the market of MS8 x RF3 for food containing or consisting of, and food produced from or containing ingredients produced from MS8 x RF3 (with the exception of processed oil) (EFSA/GMO/BE/2010/81) have also been submitted by the VKM GMO Panel (VKM 2012, unpublished). The risk assessment of the oilseed rape MS8, RF3 and MS8 x RF3 is based on information provided by the notifier in the applications EFSA/GMO/RX/MS8/RF3, EFSA/GMO/BE/2010/81, the notification C/BE/96/01, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated MS8, RF3 and MS8 x RF3 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010a) and the selection of comparators for the risk assessment of GM plants (EFSA 2011b). The scientific risk assessment of oilseed rape MS8, RF3 and MS8 x RF3 include molecular characterisation of the inserted DNA and expression of target proteins, comparative compositional assessment, food/feed safety assessment, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness and potential for horizontal and vertical gene transfer. In line with its mandate, VKM emphasised that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms. The genetically modified oilseed rape lines MS8 and RF3 were developed to provide a pollination control system for production of F1-hybrid seeds (MS8 x RF3). Oilseed rape is a crop capable of undergoing both self-pollination (70%) as well as cross-pollination (30%). Therefore a system to ensure only cross-pollination is required for producing hybrids from two distinct parents. As a result of hybrid vigor cross-pollinated plants produce higher yield as compared to self-pollinating rape. The hybrid system is achieved using a pollination control system by insertion and expression of barnase and barstar genes derived from the soil bacterium Bacillus amyloliquefaciens into two separate transgenic oilseed rape lines. The barnase gene in the male sterile line MS8 encode a ribonuclease peptide (RNase), expressed in the tapetum cells during anther development. The RNase effect RNA levels, disrupting normal cell function, arresting early anther development, and results in the lack of viable pollen and male sterility. The fertility restoration line RF3 contains a barstar gene, coding for a ribonuclease inhibitor (Barstar peptide) expressed only in the tapetum cells of the pollen during anther development. The peptide specifically inhibits the Barnase RNase expressed by the MS8 line. The RNase and the ribonuclease inhibitor form a stable one-to-one complex, in which the RNase is inactivated. As a result, when pollen from the receptor line RF3 is crossed to the male sterile line MS8, the MS8 x RF3 progeny expresses the RNase inhibitor in the tapetum cells of the anthers allowing hybrid plants to develop normal anthers and restore fertility. The barnase and barstar genes in MS8 and RF3 are each linked with the bar gene from Streptomyces hygroscopus. The bar gene is driven by a plant promoter that is active in all green tissues of the plant, and encodes the enzyme phosphinothricin acetyltransferase (PAT). The PAT enzyme inactivates phosphinothricin (PPT), the active constituent of the non-selective herbicide glufosinate-ammonium. The bar gen were transferred to the oilseed rape plants as markers both for use during in vitro selection and as a breeding selection tool in seed production. Molecular Characterisation: The oilseed rape hybrid MS8 x RF3 is produced by conventional crossing. The parental lines MS8 and RF3 are well described in the documentation provided by the applicant, and a number of publications support their data. It seems likely that MS8 contains a complete copy of the desired T-DNA construct including the bar and barnase genes. Likewise, the event RF3 is likely to contain complete copies of the bar and barstar genes in addition to a second incomplete non-functional copy of the bar-gene. The inserts in the single events are preserved in the hybrid MS8 x RF3, and the desired traits are stably inherited over generations. The GMO Panel finds the characterisation of the physical, chemical and functional properties of the recombinant inserts in the oilseed rape transformation events MS8, RF3 and MS8 x RF3 to be satisfactory. The GMO Panel has not identified any novel risks associated with the modified plants based on the molecular characterisation of the inserts. Comparative Assessment: Based on results from comparative analyses of data from field trials located at representative sites and environments in Europe and Canada, it is concluded that oilseed rape MS8, RF3 and MS8 x RF3 is compositionally, agronomically and phenotypically equivalent to the conventional counterpart, except for the newly expressed barnase, barstar and PAT proteins. In the Canadian field trials, however, compositional and phenotypic characteristics of oilseed rape MS8, RF3 and MS8 x RF3 were compared to null-segregant comparators. As negative segregants are derived from a GM organism, the VKM GMO Panel does not consider them appropriate conventional counterparts with a history of safe use. Data obtained from field trials with negative segregants were considered as supplementary information for the RA. Based on the assessment of available data, the VKM GMO Panel is of the opinion that conventional crossing of oilseed rape MS8 and RF3 to produce the hybrid MS8 x RF3 does not result in interactions that cause compositional, agronomic and phenotypic changes that would raise safety concerns. Food and Feed Risk Assessment: Whole food feeding studies in broilers have not indicated any adverse health effects of oilseed rape MS8 x RF3. These studies also indicate that oilseed rape MS8 x RF3 is nutritionally equivalent to conventional oilseed rape. The PAT protein do not show sequence resemblance to other known toxins or IgE allergens, nor has PAT been reported to cause IgE mediated allergic reactions. Based on the current knowledge, the VKM GMO Panel concludes that oilseed rape MS8 x RF3 is nutritionally equivalent to conventional oilseed rape varieties, and that it is unlikely that the newly expressed proteins introduce a toxic or allergenic potential in food and feed derived from oilseed rape MS8 x RF3 compared to conventional oilseed rape. Environmental Risk Assessment: Considering the scope of the notification C/BE/96/01, excluding cultivation purposes, the environmental risk assessment is limited to exposure through accidental spillage of viable seeds of MS8, RF3 and MS8 x RF3 into the environment during transportation, storage, handling, processing and use of derived products. Oilseed rape is mainly a self-pollinating species, but has entomophilous flowers capable of both self- and cross-pollinating. Normally the level of outcrossing is about 30 %, but outcrossing frequencies up to 55 % are reported. Several plant species related to oilseed rape that are either cultivated, occurs as weeds of cultivated and disturbed lands, or grow outside cultivation areas to which gene introgression from oilseed rape could be of concern. These are found both in the Brassica species complex and in related genera. A series of controlled crosses between oilseed rape and related taxa have been reported in the scientific literature. Because of a mismatch in the chromosome numbers most hybrids have a severely reduced fertility. Exceptions are hybrids obtained from crosses between oilseed rape and wild turnip (B. rapa ssp. campestris) and to a lesser extent, mustard greens (B.juncea), where spontaneously hybridising and transgene introgression under field conditions have been confirmed. Wild turnip is native to Norway and a common weed in arable lowlands. Accidental spillage and loss of viable seeds of MS8, RF3 and MS8 x RF3 during transport, storage, handling in the environment and processing into derived products is likely to take place over time, and the establishment of small populations of oilseed rape MS8, RF3 and MS8 x RF3 cannot be excluded. Feral oilseed rape MS8, RF3 and MS8 x RF3 arising from spilled seed could theoretically pollinate conventional crop plants if the escaped populations are immediately adjacent to field crops, and shed seeds from cross-pollinated crop plants could emerge as GM volunteers in subsequent crops. However, both the occurrence of feral oilseed rape resulting from seed import spills and the introgression of genetic material from feral oilseed rape populations to wild populations are likely to be low in an import scenario in Norway. There is no evidence that the herbicide tolerant trait results in enhanced fitness, persistence or invasiveness of oilseed rape MS8, RF3 and MS8 x RF3, or hybridizing wild relatives, compared to conventional oilseed rape varieties, unless the plants are exposed to herbicides with the active substance glufosinate ammonium. Apart from the glufosinate tolerance trait, the resulting progeny will not possess a higher fitness and will not be different from progeny arising from cross-fertilisation with conventional oilseed rape varieties. Glufosinate ammonium-containing herbicides have been withdrawn from the Norwegian market since 2008, and the substance will be phased out in the EU in 2017 for reasons of reproductive toxicity. Overall Conclusion: Based on current knowledge, the VKM GMO Panel has not identified toxic, allergenic or altered nutritional properties of oilseed rape MS8, RF3 and MS8 x RF3 or its processed products compared to conventional oilseed rape. The VKM GMO Panel likewise concludes that oilseed rape MS8, RF3 and MS8 x RF3 are unlikely to have any adverse effect on the environment and agriculture in Norway in the context of its intended usage.

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) to conduct final environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. The insect-resistant and herbicide-tolerant genetically modified maize 1507 x 59122 from Dow AgroSciences and Pioneer Hi-Bred International, Inc. (Unique Identifier DAS-Ø15Ø7-1 x DAS59122-7) is approved under Regulation (EC) No 1829/2003 for food and feed uses, import and processing since 28 July 2010 (Commission Decision 2010/432/EC). Genetically modified maize 1507 x 59122 has previously been risk assessed by the VKM Panel on Genetically Modified Organisms (GMO), commissioned by the NFSA and the Norwegian Environment Agency related to the EFSAs public hearing of the applications EFSA/GMO/NL/2005/15 and EFSA/GMO/NL/2005/28 in 2007 (VKM 2007a, 2008a). The stack 1507 x 59122 has also been evaluated by the VKM GMO Panel as single events and as a component of several other stacked GM maize events (VKM 2004, VKM 2005a,b, VKM 2007b,c, VKM 2008b,c, VKM 2009a,b, VKM 2012). The environmental risk assessment of the maize 1507 x 59122 is based on information provided by the applicant in the applications EFSA/GMO/NL/2005/15 and EFSA/GMO/NL/2005/28, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated 1507 x 59122 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2011a), the environmental risk assessment of GM plants (EFSA 2010), the selection of comparators for the risk assessment of GM plants (EFSA 2011b), and for the post-market environmental monitoring of GM plants (EFSA 2011c). The scientific risk assessment of maize 1507 x 59122 include molecular characterisation of the inserted DNA and expression of novel proteins, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness, potential for gene transfer, interactions between the GM plant and target and non-target organisms, effects on biogeochemical processes and evaluations of the post-market environmental plan. It is emphasized that the VKM mandate does not include assessments of contribution to sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act. These considerations are therefore not part of the risk assessment provided by the VKM Panel on Genetically Modified Organisms. The genetically modified maize stack 1507 x 59122 was produced by conventional breeding between inbred lines of maize containing the 1507 and 59122 events. The hybrid was developed to provide protection against certain lepidopteran and coleopteran target pests, and to confer tolerance to glufosinate-ammonium herbicides. Molecular Characterization: As conventional breeding methods were used in the production of maize 1507 x 59122, no additional genetic modification was involved. Southern and PCR analyses demonstrated that the recombinant insert in the single 1507 and 59122 events were retained in maize stack 1507 x 59122. Genetic stability of the inserts has been demonstrated in the parental lines 1507 and 59122. Phenotypic analyses demonstrated stability of the insect resistance and herbicide tolerance traits in the hybrid. The expression levels of Cry1F, Cry34Ab1/Cry35Ab1 and PAT proteins in seeds and forage were considered comparable with those in the single events. The characterisation of the recombinant insert and the physical, chemical and functional characteristics of the single events maize 1507 (VKM 2004) and maize 59122 (VKM 2005a, 2008b), have previously been evaluated by the VKM GMO Panel and considered adequate. Comparative Assessment: Comparative analyses of data from field trials located at representative sites and environments in the USA, Canada and Europe indicate that maize 1507 x 59122 is agronomically and phenotypically equivalent to the conventional counterpart, with the exception of the lepidopteran and coleopteranprotection traits and herbicide tolerance, conferred by the expression of the Cry1F, Cry34Ab1/Cry35Ab1 and PAT proteins. The field evaluations support the applicant’s conclusion of no other phenotypic changes indicative of increased plant weed/pest potential of 1507 x 59122 compared to conventional maize. The VKM GMO Panel has previously assessed these data and concluded that maize 1507 x 59122 is agronomically and phenotypically equivalent to the conventional comparators, except for the newly introduced traits (VKM 2007a, 2008a). Environmental assessment: The scope of the application EFSA/GMO/NL/2005/15 includes import and processing of maize 1507 x 59122 for food and feed uses. Considering the intended uses of maize 1507 x 59122, excluding cultivation, the environmental risk assessment has been concerned with accidental release into the environment of viable grains during transportation and processing, and indirect exposure, mainly through manure and faeces from animals fed grains from maize 1507 x 59122. The available data indicate that 1507 x 59122 has no altered survival, multiplication or dissemination characteristics, and there are no indications of an increased likelihood of spread and establishment of feral maize plants in the case of accidental release into the environment of seeds from maize 1507 x 59122. Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivation. The VKM GMO Panel considers the risk of gene flow from occasional feral GM maize plants to conventional maize varieties to be negligible in Norway. Considering the intended use as food and feed, interactions with the biotic and abiotic environment are not considered by the GMO Panel to be an issue. Overall Conclusion: The VKM GMO Panel concludes that maize 1507 x 59122, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.

Discussions of the economic theory of planned obsolescence—the purposeful embedding of redundancy into the functionality or other aspect of a product—in the 1980s and 1990s often focused on the impact of such a design strategy on manufacturers, consumers, the market, and, ultimately, profits (see, for example, Bulow; Lee and Lee; Waldman). More recently, assessments of such shortened product life cycles have included calculations of the environmental and other costs of such waste (Claudio; Kondoh; Unruh). Commonly utilised examples are consumer products such as cars, whitegoods and small appliances, fashion clothing and accessories, and, more recently, new technologies and their constituent components. This discourse has been adopted by those who configure workers as human resources, and who speak both of skills (Janßen and Backes-Gellner) and human capital itself (Chauhan and Chauhan) being made obsolete by market forces in both predictable and unplanned ways. This includes debate over whether formal education can assist in developing the skills that make their possessors less liable to become obsolete in the workforce (Dubin; Holtmann; Borghans and de Grip; Gould, Moav and Weinberg). However, aside from periodic expressions of disciplinary angst (as in questions such as whether the Liberal Arts and other disciplines are becoming obsolete) are rarely found in discussions regarding higher education. Yet, higher education has been subsumed into a culture of commercial service provision as driven by markets and profit as the industries that design and deliver consumer goods. McKelvey and Holmén characterise this as a shift “from social institution to knowledge business” in the subtitle of their 2009 volume on European universities, and the recent decade has seen many higher educational institutions openly striving to be entrepreneurial. Despite some debate over the functioning of market or market-like mechanisms in higher education (see, for instance, Texeira et al), the corporatisation of higher education has led inevitably to market segmentation in the products the sector delivers. Such market segmentation results in what are called over-differentiated products, seemingly endless variations in the same product to attempt to increase consumption and attendant sales. Milk is a commonly cited example, with supermarkets today stocking full cream, semi-skimmed, skimmed, lactose-free, soy, rice, goat, GM-free and ‘smart’ (enriched with various vitamins, minerals and proteins) varieties; and many of these available in fresh, UHT, dehydrated and/or organic versions. In the education market, this practice has resulted in a large number of often minutely differentiated, but differently named, degrees and other programs. Where there were once a small number of undergraduate degrees with discipline variety within them (including the Bachelor of Arts and Bachelor of Science awards), students can now graduate with a named qualification in a myriad of discipline and professional areas. The attempt to secure a larger percentage of the potential client pool (who are themselves often seeking to update their own skills and knowledges to avoid workforce obsolescence) has also resulted in a significant increase in the number of postgraduate coursework certificates, diplomas and other qualifications across the sector. The Masters degree has fractured from a research program into a range of coursework, coursework plus research, and research only programs. Such proliferation has also affected one of the foundations of the quality and integrity of the higher education system, and one of the last bastions of conventional practice, the doctoral degree. The PhD as ‘Gold-Standard’ Market Leader? The Doctor of Philosophy (PhD) is usually understood as a largely independent discipline-based research project that results in a substantial piece of reporting, the thesis, that makes a “substantial original contribution to knowledge in the form of new knowledge or significant and original adaptation, application and interpretation of existing knowledge” (AQF). As the highest level of degree conferred by most universities, the PhD is commonly understood as indicating the height of formal educational attainment, and has, until relatively recently, been above reproach and alteration. Yet, whereas universities internationally once offered a single doctorate named the PhD, many now offer a number of doctoral level degrees. In Australia, for example, candidates can also complete PhDs by Publication and by Project, as well as practice-led doctorates in, and named Doctorates of/in, Creative Arts, Creative Industries, Laws, Performance and other ‘new’ discipline areas. The Professional Doctorate, introduced into Australia in the early 1990s, has achieved such longevity that it now has it’s own “first generation” incarnations in (and about) disciplines such as Education, Business, Psychology and Journalism, as well as a contemporary “second generation” version which features professionally-practice-led Mode 2 knowledge production (Maxwell; also discussed in Lee, Brennan and Green 281). The uniquely Australian PhD by Project in the disciplines of architecture, design, business, engineering and education also includes coursework, and is practice and particularly workplace (or community) focused, but unlike the above, does not have to include a research element—although this is not precluded (Usher). A significant number of Australian universities also currently offer a PhD by Publication, known also as the PhD by Published Papers and PhD by Published Works. Introduced in the 1960s in the UK, the PhD by Publication there is today almost exclusively undertaken by academic staff at their own institutions, and usually consists of published work(s), a critical appraisal of that work within the research context, and an oral examination. The named degree is rare in the USA, although the practice of granting PhDs on the basis of prior publications is not unknown. In Australia, an examination of a number of universities that offer the degree reveals no consistency in terms of the framing policies except for the generic Australian Qualifications Framework accreditation statement (AQF), entry requirements and conditions of candidature, or resulting form and examination guidelines. Some Australian universities, for instance, require all externally peer-refereed publications, while others will count works that are self-published. Some require actual publications or works in press, but others count works that are still at submission stage. The UK PhD by Publication shows similar variation, with no consensus on purpose, length or format of this degree (Draper). Across Australia and the UK, some institutions accept previously published work and require little or no campus participation, while others have a significant minimum enrolment period and count only work generated during candidature (see Brien for more detail). Despite the plethora of named degrees at doctoral level, many academics continue to support the PhD’s claim to rigor and intellectual attainment. Most often, however, these arguments cite tradition rather than any real assessment of quality. The archaic trappings of conferral—the caps, gowns and various other instruments of distinction—emphasise a narrative in which it is often noted that doctorates were first conferred by the University of Paris in the 12th century and then elsewhere in medieval Europe. However, challenges to this account note that today’s largely independently researched thesis is a relatively recent arrival to educational history, being only introduced into Germany in the early nineteenth century (Bourner, Bowden and Laing; Park 4), the USA in a modified form in the mid-nineteenth century and the UK in 1917 (Jolley 227). The Australian PhD is even more recent, with the first only awarded in 1948 and still relatively rare until the 1970s (Nelson 3; Valadkhani and Ville). Additionally, PhDs in the USA, Canada and Denmark today almost always incorporate a significant taught coursework element (Noble). This is unlike the ‘traditional’ PhD in the UK and Australia, although the UK also currently offers a number of what are known there as ‘taught doctorates’. Somewhat confusingly, while these do incorporate coursework, they still include a significant research component (UKCGE). However, the UK is also adopting what has been identified as an American-inflected model which consists mostly, or largely, of coursework, and which is becoming known as the ‘New Route British PhD’ (Jolley 228). It could be posited that, within such a competitive market environment, which appears to be driven by both a drive for novelty and a desire to meet consumer demand, obsolescence therefore, and necessarily, threatens the very existence of the ‘traditional’ PhD. This obsolescence could be seen as especially likely as, alongside the existence of the above mentioned ‘new’ degrees, the ‘traditional’ research-based PhD at some universities in Australia and the UK in particular is, itself, also in the process of becoming ‘professionalised’, with some (still traditionally-framed) programs nevertheless incorporating workplace-oriented frameworks and/or experiences (Jolley 229; Kroll and Brien) to meet professionally-focused objectives that it is acknowledged cannot be met by producing a research thesis alone. While this emphasis can be seen as operating at the expense of specific disciplinary knowledge (Pole 107; Ball; Laing and Brabazon 265), and criticised for that, this workplace focus has arisen, internationally, as an institutional response to requests from both governments and industry for training in generic skills in university programs at all levels (Manathunga and Wissler). At the same time, the acknowledged unpredictability of the future workplace is driving a cognate move from discipline specific knowledge to what have been described as “problem solving and knowledge management approaches” across all disciplines (Gilbert; Valadkhani and Ville 2). While few query a link between university-level learning and the needs of the workplace, or the motivating belief that the overarching role of higher education is the provision of professional training for its client-students (see Laing and Brabazon for an exception), it also should be noted that a lack of relevance is one of the contributors to dysfunction, and thence to obsolescence. The PhD as Dysfunctional Degree? Perhaps, however, it is not competition that threatens the traditional PhD but, rather, its own design flaws. A report in The New York Times in 2007 alerted readers to what many supervisors, candidates, and researchers internationally have recognised for some time: that the PhD may be dysfunctional (Berger). In Australia and elsewhere, attention has focused on the uneven quality of doctoral-level degrees across institutions, especially in relation to their content, rigor, entry and assessment standards, and this has not precluded questions regarding the PhD (AVCC; Carey, Webb, Brien; Neumann; Jolley; McWilliam et al., "Silly"). It should be noted that this important examination of standards has, however, been accompanied by an increase in the awarding of Honorary Doctorates. This practice ranges from the most reputable universities’ recognising individuals’ significant contributions to knowledge, culture and/or society, to wholly disreputable institutions offering such qualifications in return for payment (Starrs). While generally contested in terms of their status, Honorary Doctorates granted to sports, show business and political figures are the most controversial and include an award conferred on puppet Kermit the Frog in 1996 (Jeffries), and some leading institutions including MIT, Cornell University and the London School of Economics and Political Science are distinctive in not awarding Honorary Doctorates. However, while distracting, the Honorary Doctorate itself does not answer all the questions regarding the quality of doctoral programs in general, or the Doctor of Philosophy in particular. The PhD also has high attrition rates: 50 per cent or more across Australia, the USA and Canada (Halse 322; Lovitts and Nelson). For those who remain in the programs, lengthy completion times (known internationally as ‘time-to-degree’) are common in many countries, with averages of 10.5 years to completion in Canada, and from 8.2 to more than 13 years (depending on discipline) in the USA (Berger). The current government performance-based funding model for Australian research higher degrees focuses attention on timely completion, and there is no doubt that, under this system—where universities only receive funding for a minimum period of candidature when those candidates have completed their degrees—more candidates are completing within the required time periods (Cuthbert). Yet, such a focus has distracted from assessment of the quality and outcomes of such programs of study. A detailed survey, based on the theses lodged in Australian libraries, has estimated that at least 51,000 PhD theses were completed in Australia to 2003 (Evans et al. 7). However, little attention has been paid to the consequences of this work, that is, the effects that the generation of these theses has had on either candidates or the nation. There has been no assessment, for instance, of the impact on candidates of undertaking and completing a doctorate on such facets of their lives as their employment opportunities, professional choices and salary levels, nor any effect on their personal happiness or levels of creativity. Nor has there been any real evaluation of the effect of these degrees on GDP, rates of the commercialisation of research, the generation of intellectual property, meeting national agendas in areas such as innovation, productivity or creativity, and/or the quality of the Australian creative and performing arts. Government-funded and other Australian studies have, however, noted for at least a decade both that the high numbers of graduates are mismatched to a lack of market demand for doctoral qualifications outside of academia (Kemp), and that an oversupply of doctorally qualified job seekers is driving wages down in some sectors (Jones 26). Even academia is demanding more than a PhD. Within the USA, doctoral graduates of some disciplines (English is an often-cited example) are undertaking second PhDs in their quest to secure an academic position. In Australia, entry-level academic positions increasingly require a scholarly publishing history alongside a doctoral-level qualification and, in common with other quantitative exercises in the UK and in New Zealand, the current Excellence in Research for Australia research evaluation exercise values scholarly publications more than higher degree qualifications. Concluding Remarks: The PhD as Obsolete or Retro-Chic? Disciplines and fields are reacting to this situation in various ways, but the trend appears to be towards increased market segmentation. Despite these charges of PhD dysfunction, there are also dangers in the over-differentiation of higher degrees as a practice. If universities do not adequately resource the professional development and other support for supervisors and all those involved in the delivery of all these degrees, those institutions may find that they have spread the existing skills, knowledge and other institutional assets too thinly to sustain some or even any of these degrees. This could lead to the diminishing quality (and an attendant diminishing perception of the value) of all the higher degrees available in those institutions as well as the reputation of the hosting country’s entire higher education system. As works in progress, the various ‘new’ doctoral degrees can also promote a sense of working on unstable ground for both candidates and supervisors (McWilliam et al., Research Training), and higher degree examiners will necessarily be unfamiliar with expected standards. Candidates are attempting to discern the advantages and disadvantages of each form in order to choose the degree that they believe is right for them (see, for example, Robins and Kanowski), but such assessment is difficult without the benefit of hindsight. Furthermore, not every form may fit the unpredictable future aspirations of candidates or the volatile future needs of the workplace. The rate with which everything once new descends from stylish popularity through stages of unfashionableness to become outdated and, eventually, discarded is increasing. This escalation may result in the discipline-based research PhD becoming seen as archaic and, eventually, obsolete. Perhaps, alternatively, it will lead to newer and more fashionable forms of doctoral study being discarded instead. Laing and Brabazon go further to find that all doctoral level study’s inability to “contribute in a measurable and quantifiable way to social, economic or political change” problematises the very existence of all these degrees (265). Yet, we all know that some objects, styles, practices and technologies that become obsolete are later recovered and reassessed as once again interesting. They rise once again to be judged as fashionable and valuable. Perhaps even if made obsolete, this will be the fate of the PhD or other doctoral degrees?References Australian Qualifications Framework (AQF). “Doctoral Degree”. AQF Qualifications. 4 May 2009 ‹http://www.aqf.edu.au/doctor.htm›. Australian Vice-Chancellors’ Committee (AVCC). Universities and Their Students: Principles for the Provision of Education by Australian Universities. Canberra: AVCC, 2002. 4 May 2009 ‹http://www.universitiesaustralia.edu.au/documents/publications/Principles_final_Dec02.pdf›. 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A same-but-different dichotomy has recently been encapsulated within the US Food and Drug Administration’s ill-defined concept of “substantial equivalence” (USFDA, FDA). By invoking this concept the genetically modified organism (GMO) industry has escaped the rigors of safety testing that might otherwise apply. The curious concept of “substantial equivalence” grants a presumption of safety to GMO food. This presumption has yet to be earned, and has been used to constrain labelling of both GMO and non-GMO food. It is an idea that well serves corporatism. It enables the claim of difference to secure patent protection, while upholding the contrary claim of sameness to avoid labelling and safety scrutiny. It offers the best of both worlds for corporate food entrepreneurs, and delivers the worst of both worlds to consumers. The term “substantial equivalence” has established its currency within the GMO discourse. As the opportunities for patenting food technologies expand, the GMO recruitment of this concept will likely be a dress rehearsal for the developing debates on the labelling and testing of other techno-foods – including nano-foods and clone-foods. “Substantial Equivalence” “Are the Seven Commandments the same as they used to be, Benjamin?” asks Clover in George Orwell’s “Animal Farm”. By way of response, Benjamin “read out to her what was written on the wall. There was nothing there now except a single Commandment. It ran: ALL ANIMALS ARE EQUAL BUT SOME ANIMALS ARE MORE EQUAL THAN OTHERS”. After this reductionist revelation, further novel and curious events at Manor Farm, “did not seem strange” (Orwell, ch. X). Equality is a concept at the very core of mathematics, but beyond the domain of logic, equality becomes a hotly contested notion – and the domain of food is no exception. A novel food has a regulatory advantage if it can claim to be the same as an established food – a food that has proven its worth over centuries, perhaps even millennia – and thus does not trigger new, perhaps costly and onerous, testing, compliance, and even new and burdensome regulations. On the other hand, such a novel food has an intellectual property (IP) advantage only in terms of its difference. And thus there is an entrenched dissonance for newly technologised foods, between claiming sameness, and claiming difference. The same/different dilemma is erased, so some would have it, by appeal to the curious new dualist doctrine of “substantial equivalence” whereby sameness and difference are claimed simultaneously, thereby creating a win/win for corporatism, and a loss/loss for consumerism. This ground has been pioneered, and to some extent conquered, by the GMO industry. The conquest has ramifications for other cryptic food technologies, that is technologies that are invisible to the consumer and that are not evident to the consumer other than via labelling. Cryptic technologies pertaining to food include GMOs, pesticides, hormone treatments, irradiation and, most recently, manufactured nano-particles introduced into the food production and delivery stream. Genetic modification of plants was reported as early as 1984 by Horsch et al. The case of Diamond v. Chakrabarty resulted in a US Supreme Court decision that upheld the prior decision of the US Court of Customs and Patent Appeal that “the fact that micro-organisms are alive is without legal significance for purposes of the patent law”, and ruled that the “respondent’s micro-organism plainly qualifies as patentable subject matter”. This was a majority decision of nine judges, with four judges dissenting (Burger). It was this Chakrabarty judgement that has seriously opened the Pandora’s box of GMOs because patenting rights makes GMOs an attractive corporate proposition by offering potentially unique monopoly rights over food. The rear guard action against GMOs has most often focussed on health repercussions (Smith, Genetic), food security issues, and also the potential for corporate malfeasance to hide behind a cloak of secrecy citing commercial confidentiality (Smith, Seeds). Others have tilted at the foundational plank on which the economics of the GMO industry sits: “I suggest that the main concern is that we do not want a single molecule of anything we eat to contribute to, or be patented and owned by, a reckless, ruthless chemical organisation” (Grist 22). The GMO industry exhibits bipolar behaviour, invoking the concept of “substantial difference” to claim patent rights by way of “novelty”, and then claiming “substantial equivalence” when dealing with other regulatory authorities including food, drug and pesticide agencies; a case of “having their cake and eating it too” (Engdahl 8). This is a clever slight-of-rhetoric, laying claim to the best of both worlds for corporations, and the worst of both worlds for consumers. Corporations achieve patent protection and no concomitant specific regulatory oversight; while consumers pay the cost of patent monopolization, and are not necessarily apprised, by way of labelling or otherwise, that they are purchasing and eating GMOs, and thereby financing the GMO industry. The lemma of “substantial equivalence” does not bear close scrutiny. It is a fuzzy concept that lacks a tight testable definition. It is exactly this fuzziness that allows lots of wriggle room to keep GMOs out of rigorous testing regimes. Millstone et al. argue that “substantial equivalence is a pseudo-scientific concept because it is a commercial and political judgement masquerading as if it is scientific. It is moreover, inherently anti-scientific because it was created primarily to provide an excuse for not requiring biochemical or toxicological tests. It therefore serves to discourage and inhibit informative scientific research” (526). “Substantial equivalence” grants GMOs the benefit of the doubt regarding safety, and thereby leaves unexamined the ramifications for human consumer health, for farm labourer and food-processor health, for the welfare of farm animals fed a diet of GMO grain, and for the well-being of the ecosystem, both in general and in its particularities. “Substantial equivalence” was introduced into the food discourse by an Organisation for Economic Co-operation and Development (OECD) report: “safety evaluation of foods derived by modern biotechnology: concepts and principles”. It is from this document that the ongoing mantra of assumed safety of GMOs derives: “modern biotechnology … does not inherently lead to foods that are less safe … . Therefore evaluation of foods and food components obtained from organisms developed by the application of the newer techniques does not necessitate a fundamental change in established principles, nor does it require a different standard of safety” (OECD, “Safety” 10). This was at the time, and remains, an act of faith, a pro-corporatist and a post-cautionary approach. The OECD motto reveals where their priorities lean: “for a better world economy” (OECD, “Better”). The term “substantial equivalence” was preceded by the 1992 USFDA concept of “substantial similarity” (Levidow, Murphy and Carr) and was adopted from a prior usage by the US Food and Drug Agency (USFDA) where it was used pertaining to medical devices (Miller). Even GMO proponents accept that “Substantial equivalence is not intended to be a scientific formulation; it is a conceptual tool for food producers and government regulators” (Miller 1043). And there’s the rub – there is no scientific definition of “substantial equivalence”, no scientific test of proof of concept, and nor is there likely to be, since this is a ‘spinmeister’ term. And yet this is the cornerstone on which rests the presumption of safety of GMOs. Absence of evidence is taken to be evidence of absence. History suggests that this is a fraught presumption. By way of contrast, the patenting of GMOs depends on the antithesis of assumed ‘sameness’. Patenting rests on proven, scrutinised, challengeable and robust tests of difference and novelty. Lightfoot et al. report that transgenic plants exhibit “unexpected changes [that] challenge the usual assumptions of GMO equivalence and suggest genomic, proteomic and metanomic characterization of transgenics is advisable” (1). GMO Milk and Contested Labelling Pesticide company Monsanto markets the genetically engineered hormone rBST (recombinant Bovine Somatotropin; also known as: rbST; rBGH, recombinant Bovine Growth Hormone; and the brand name Prosilac) to dairy farmers who inject it into their cows to increase milk production. This product is not approved for use in many jurisdictions, including Europe, Australia, New Zealand, Canada and Japan. Even Monsanto accepts that rBST leads to mastitis (inflammation and pus in the udder) and other “cow health problems”, however, it maintains that “these problems did not occur at rates that would prohibit the use of Prosilac” (Monsanto). A European Union study identified an extensive list of health concerns of rBST use (European Commission). The US Dairy Export Council however entertain no doubt. In their background document they ask “is milk from cows treated with rBST safe?” and answer “Absolutely” (USDEC). Meanwhile, Monsanto’s website raises and answers the question: “Is the milk from cows treated with rbST any different from milk from untreated cows? No” (Monsanto). Injecting cows with genetically modified hormones to boost their milk production remains a contested practice, banned in many countries. It is the claimed equivalence that has kept consumers of US dairy products in the dark, shielded rBST dairy farmers from having to declare that their milk production is GMO-enhanced, and has inhibited non-GMO producers from declaring their milk as non-GMO, non rBST, or not hormone enhanced. This is a battle that has simmered, and sometimes raged, for a decade in the US. Finally there is a modest victory for consumers: the Pennsylvania Department of Agriculture (PDA) requires all labels used on milk products to be approved in advance by the department. The standard issued in October 2007 (PDA, “Standards”) signalled to producers that any milk labels claiming rBST-free status would be rejected. This advice was rescinded in January 2008 with new, specific, department-approved textual constructions allowed, and ensuring that any “no rBST” style claim was paired with a PDA-prescribed disclaimer (PDA, “Revised Standards”). However, parsimonious labelling is prohibited: No labeling may contain references such as ‘No Hormones’, ‘Hormone Free’, ‘Free of Hormones’, ‘No BST’, ‘Free of BST’, ‘BST Free’,’No added BST’, or any statement which indicates, implies or could be construed to mean that no natural bovine somatotropin (BST) or synthetic bovine somatotropin (rBST) are contained in or added to the product. (PDA, “Revised Standards” 3) Difference claims are prohibited: In no instance shall any label state or imply that milk from cows not treated with recombinant bovine somatotropin (rBST, rbST, RBST or rbst) differs in composition from milk or products made with milk from treated cows, or that rBST is not contained in or added to the product. If a product is represented as, or intended to be represented to consumers as, containing or produced from milk from cows not treated with rBST any labeling information must convey only a difference in farming practices or dairy herd management methods. (PDA, “Revised Standards” 3) The PDA-approved labelling text for non-GMO dairy farmers is specified as follows: ‘From cows not treated with rBST. No significant difference has been shown between milk derived from rBST-treated and non-rBST-treated cows’ or a substantial equivalent. Hereinafter, the first sentence shall be referred to as the ‘Claim’, and the second sentence shall be referred to as the ‘Disclaimer’. (PDA, “Revised Standards” 4) It is onto the non-GMO dairy farmer alone, that the costs of compliance fall. These costs include label preparation and approval, proving non-usage of GMOs, and of creating and maintaining an audit trail. In nearby Ohio a similar consumer versus corporatist pantomime is playing out. This time with the Ohio Department of Agriculture (ODA) calling the shots, and again serving the GMO industry. The ODA prescribed text allowed to non-GMO dairy farmers is “from cows not supplemented with rbST” and this is to be conjoined with the mandatory disclaimer “no significant difference has been shown between milk derived from rbST-supplemented and non-rbST supplemented cows” (Curet). These are “emergency rules”: they apply for 90 days, and are proposed as permanent. Once again, the onus is on the non-GMO dairy farmers to document and prove their claims. GMO dairy farmers face no such governmental requirements, including no disclosure requirement, and thus an asymmetric regulatory impost is placed on the non-GMO farmer which opens up new opportunities for administrative demands and technocratic harassment. Levidow et al. argue, somewhat Eurocentrically, that from its 1990s adoption “as the basis for a harmonized science-based approach to risk assessment” (26) the concept of “substantial equivalence” has “been recast in at least three ways” (58). It is true that the GMO debate has evolved differently in the US and Europe, and with other jurisdictions usually adopting intermediate positions, yet the concept persists. Levidow et al. nominate their three recastings as: firstly an “implicit redefinition” by the appending of “extra phrases in official documents”; secondly, “it has been reinterpreted, as risk assessment processes have … required more evidence of safety than before, especially in Europe”; and thirdly, “it has been demoted in the European Union regulatory procedures so that it can no longer be used to justify the claim that a risk assessment is unnecessary” (58). Romeis et al. have proposed a decision tree approach to GMO risks based on cascading tiers of risk assessment. However what remains is that the defects of the concept of “substantial equivalence” persist. Schauzu identified that: such decisions are a matter of “opinion”; that there is “no clear definition of the term ‘substantial’”; that because genetic modification “is aimed at introducing new traits into organisms, the result will always be a different combination of genes and proteins”; and that “there is no general checklist that could be followed by those who are responsible for allowing a product to be placed on the market” (2). Benchmark for Further Food Novelties? The discourse, contestation, and debate about “substantial equivalence” have largely focussed on the introduction of GMOs into food production processes. GM can best be regarded as the test case, and proof of concept, for establishing “substantial equivalence” as a benchmark for evaluating new and forthcoming food technologies. This is of concern, because the concept of “substantial equivalence” is scientific hokum, and yet its persistence, even entrenchment, within regulatory agencies may be a harbinger of forthcoming same-but-different debates for nanotechnology and other future bioengineering. The appeal of “substantial equivalence” has been a brake on the creation of GMO-specific regulations and on rigorous GMO testing. The food nanotechnology industry can be expected to look to the precedent of the GMO debate to head off specific nano-regulations and nano-testing. As cloning becomes economically viable, then this may be another wave of food innovation that muddies the regulatory waters with the confused – and ultimately self-contradictory – concept of “substantial equivalence”. Nanotechnology engineers particles in the size range 1 to 100 nanometres – a nanometre is one billionth of a metre. This is interesting for manufacturers because at this size chemicals behave differently, or as the Australian Office of Nanotechnology expresses it, “new functionalities are obtained” (AON). Globally, government expenditure on nanotechnology research reached US$4.6 billion in 2006 (Roco 3.12). While there are now many patents (ETC Group; Roco), regulation specific to nanoparticles is lacking (Bowman and Hodge; Miller and Senjen). The USFDA advises that nano-manufacturers “must show a reasonable assurance of safety … or substantial equivalence” (FDA). A recent inventory of nano-products already on the market identified 580 products. Of these 11.4% were categorised as “Food and Beverage” (WWICS). This is at a time when public confidence in regulatory bodies is declining (HRA). In an Australian consumer survey on nanotechnology, 65% of respondents indicated they were concerned about “unknown and long term side effects”, and 71% agreed that it is important “to know if products are made with nanotechnology” (MARS 22). Cloned animals are currently more expensive to produce than traditional animal progeny. In the course of 678 pages, the USFDA Animal Cloning: A Draft Risk Assessment has not a single mention of “substantial equivalence”. However the Federation of Animal Science Societies (FASS) in its single page “Statement in Support of USFDA’s Risk Assessment Conclusion That Food from Cloned Animals Is Safe for Human Consumption” states that “FASS endorses the use of this comparative evaluation process as the foundation of establishing substantial equivalence of any food being evaluated. It must be emphasized that it is the food product itself that should be the focus of the evaluation rather than the technology used to generate cloned animals” (FASS 1). Contrary to the FASS derogation of the importance of process in food production, for consumers both the process and provenance of production is an important and integral aspect of a food product’s value and identity. Some consumers will legitimately insist that their Kalamata olives are from Greece, or their balsamic vinegar is from Modena. It was the British public’s growing awareness that their sugar was being produced by slave labour that enabled the boycotting of the product, and ultimately the outlawing of slavery (Hochschild). When consumers boycott Nestle, because of past or present marketing practices, or boycott produce of USA because of, for example, US foreign policy or animal welfare concerns, they are distinguishing the food based on the narrative of the food, the production process and/or production context which are a part of the identity of the food. Consumers attribute value to food based on production process and provenance information (Paull). Products produced by slave labour, by child labour, by political prisoners, by means of torture, theft, immoral, unethical or unsustainable practices are different from their alternatives. The process of production is a part of the identity of a product and consumers are increasingly interested in food narrative. It requires vigilance to ensure that these narratives are delivered with the product to the consumer, and are neither lost nor suppressed. Throughout the GM debate, the organic sector has successfully skirted the “substantial equivalence” debate by excluding GMOs from the certified organic food production process. This GMO-exclusion from the organic food stream is the one reprieve available to consumers worldwide who are keen to avoid GMOs in their diet. The organic industry carries the expectation of providing food produced without artificial pesticides and fertilizers, and by extension, without GMOs. Most recently, the Soil Association, the leading organic certifier in the UK, claims to be the first organisation in the world to exclude manufactured nonoparticles from their products (Soil Association). There has been the call that engineered nanoparticles be excluded from organic standards worldwide, given that there is no mandatory safety testing and no compulsory labelling in place (Paull and Lyons). The twisted rhetoric of oxymorons does not make the ideal foundation for policy. Setting food policy on the shifting sands of “substantial equivalence” seems foolhardy when we consider the potentially profound ramifications of globally mass marketing a dysfunctional food. If there is a 2×2 matrix of terms – “substantial equivalence”, substantial difference, insubstantial equivalence, insubstantial difference – while only one corner of this matrix is engaged for food policy, and while the elements remain matters of opinion rather than being testable by science, or by some other regime, then the public is the dupe, and potentially the victim. “Substantial equivalence” has served the GMO corporates well and the public poorly, and this asymmetry is slated to escalate if nano-food and clone-food are also folded into the “substantial equivalence” paradigm. Only in Orwellian Newspeak is war peace, or is same different. It is time to jettison the pseudo-scientific doctrine of “substantial equivalence”, as a convenient oxymoron, and embrace full disclosure of provenance, process and difference, so that consumers are not collateral in a continuing asymmetric knowledge war. References Australian Office of Nanotechnology (AON). 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