EU safety regulations – Dont mar legislation with pseudoscience

328. Dietrich DR, Dekant W, Greim H, Heslop-Harrison P, Berry C, Boobis A, Hengstler JG, Sharpe R. 2016. EU safety regulations: Don’t mar legislation with pseudoscience. Nature 535: 355 (21 July 2016) doi:10.1038/535355c

We are concerned that some of the European Union’s processes for setting safety regulations for chemicals are being influenced by media and pseudoscience scaremongering. Pseudoscience has no place in such decisions, which should be based purely on well-defined and transparent evidence.

For example, endocrine disruptors are being blamed for obesity and type 2 diabetes (J. Legler et al. J. Clin. Endocrinol. Metab. 100, 12781288; 2015) despite the absence of supporting evidence for this, and despite food and sugar over-consumption being established as a proven cause. As a consequence, the European Commission’s criteria for regulating endocrine-disrupting compounds as a threat to human health are based on correlational, not causal, studies (see go.nature.com/29rjlik).

Conflicts of interest can contribute to the problem, beyond the commercial motivation of industry. Some non-governmental organizations might need to maintain public concerns to boost charitable donations. Decision-makers might prefer to disregard evidence-based data that contradict a precautionary viewpoint. And some scientists put securing research funds above objective appraisal of the evidence.

Acting on hazard identification alone relieves the scaremongering party of the burden of proof, when harm is simply assumed. As a result, regulations can become unnecessarily restrictive. They may even be damaging, for example if an agricultural ban were to be imposed on triazole fungicides because of their endocrine-disrupting potential. The risk to humans at such levels of exposure would be negligible (J. E. Chambers et al. Crit. Rev. Toxicol. 44, 176210; 2014). It makes no sense to override such evidence with a blanket ban on potentially hazardous chemicals that ignores the public’s demonstrable low level of exposure.

http://www.nature.com/nature/journal/v535/n7612/extref/535355c-s1.pdf

 

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Molecular Cytogenetics Group – an infographic of what we do

Infographic: what we do in the Molecular Cytogenetics Research Group

Infographic: what we do in the Molecular Cytogenetics Research Group

Infographic: what we do in the Molecular Cytogenetics Research Group

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Introgression of chromosome segments from multiple alien species in wheat breeding lines with wheat streak mosaic virus resistance

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324. Ali N, Heslop-Harrison JS, Ahmad H, Graybosch RA, Hein GL, Schwarzacher T. 2016. Introgression of chromosome segments from multiple alien species in wheat breeding lines with wheat streak mosaic virus resistance. Heredity (2016) 117, 114–123; published online 1 June 2016 doi:10.1038/hdy.2016.36

Author version: N_Ali_et al 2016 Multiple Alien Introgressions in Wheat

Publisher site: http://www.nature.com/hdy/journal/vaop/ncurrent/pdf/hdy201636a.pdf

Pyramiding of alien-derived Wheat streak mosaic virus (WSMV) resistance and resistance enhancing genes in wheat is a cost-effective and environmentally safe strategy for disease control. PCR-based markers and cytogenetic analysis with genomic in situ hybridization were applied to identify alien chromatin in four genetically diverse populations of wheat (Triticum aestivum) lines incorporating chromosome segments from Thinopyrum intermedium and Secale cereale (rye). Out of twenty experimental lines, ten carried Th. intermedium chromatin as T4DL*4Ai#2S translocations, while, unexpectedly, seven lines were positive for alien chromatin (Th. intermedium or rye) on chromosome 1B. The newly described rye 1RS chromatin, transmitted from early in the pedigree, was associated with enhanced WSMV-resistance. Under field conditions, the 1RS chromatin alone showed some resistance, while together with the Th. intermedium 4Ai#2S offered superior resistance to that demonstrated by the known resistant cultivar Mace. Most alien-wheat lines carry whole chromosome arms, and it is notable that these lines showed intra-arm recombination within the 1BS arm. The translocation breakpoints between 1BS and alien chromatin fell in three categories: 1) at or near to the centromere, 2) intercalary between markers UL-Thin5 and Xgwm1130, and 3) towards the telomere between Xgwm0911 and Xbarc194. Labelled genomic Th. intermedium DNA hybridized to the rye 1RS chromatin under high stringency conditions, indicating the presence of shared tandem repeats among the cereals. The novel small alien fragments may explain the difficulty in developing well-adapted lines carrying Wsm1 despite improved tolerance to the virus. The results will facilitate directed chromosome engineering producing agronomically desirable WSMV-resistant germplasm.

KEYWORDS

Fluorescent in situ hybridization, molecular markers, wheat, Thinopyrum intermedium, rye, Wheat streak mosaic virus

 

Author version: N_Ali_et al 2016 Multiple Alien Introgressions in Wheat

Publisher site: http://www.nature.com/hdy/journal/vaop/ncurrent/pdf/hdy201636a.pdf

 

 

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Insight into the evolution of the Solanaceae from the parental genomes of Petunia hybrida

Petunia hybrida flowers: sequenced by a consortium including the MolCyt,.com lab

Petunia hybrida flowers: sequenced by a consortium including the MolCyt.com lab

325b. Bombarely, Moser M, Amrad A, Bao M, Bapaume L, Barry CS,  Bliek M, Boersma MR, Borghi L, Bruggmann R, Bucher M, D’Agostino N, Davies K, Druege U, Dudareva N, Egea-Cortines M, Delledonne M, Fernandez-Pozo N, Franken P, Grandont L, Heslop-Harrison JS, Hintzsche J, Johns M, Koes R, Lv X, Lyons E, Malla D, Martinoia E, Mattson NS, Morel P, Mueller LA, Muhlemann J, Nouri E, Passeri V, Pezzotti M, Qi Q, Reinhardt D, Rich M, Richert-Pöggeler KR, Robbins TP, Schatz MC, Schranz ME, Schuurink RC, Schwarzacher T, Spelt K, Tang H, Urbanus S, Vandenbussche M, Vijverberg K, Villarino GH, Warner RM, Weiss J, Yue Z, Zethof J, Quattrocchio F, Sims TL, Kuhlemeier C. 2016. Insight into the evolution of the Solanaceae from the parental genomes of Petunia hybrida. Nature Plants 2: article number 16074.

http://dx.doi.org/10.1038/nplants.2016.74

Petunia hybrida is a popular bedding plant that has a long history as a genetic model system. We report the whole-genome sequencing and assembly of inbred derivatives of its two wild parents, P. axillaris N and P. inflata S6. The assemblies include 91.3% and 90.2% coverage of their diploid genomes (1.4 Gb; 2n=14) containing 32,928 and 36,697 protein-coding genes, respectively. The genomes reveal that the Petunia lineage has experienced at least two rounds of hexaploidization, the older gamma event, which is shared with most Eudicots, and a more recent Solanaceae event that is shared with tomato and other solanaceous species. Transcription factors involved in the shift from bee- to moth pollination reside in particularly dynamic regions of the genome, which may have been key to the remarkable diversity of floral color patterns and pollination systems. The high quality genome sequences will enhance the value of Petunia as a model system for research on unique biological phenomena such as small RNAs, symbiosis, self-incompatibility and circadian rhythms.

 

See also related / supplementary manuscript from Molecular Cytogenetics lab.

 

 

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Analysis of Petunia vein clearing virus (PVCV) sequences, retroelements and tandem repeats in Petunia axillaris N and P. inflata S6

PetuniaNaturePVCVchromosomes.jpg325a. Schwarzacher T, Heslop-Harrison JS, Richert-Pöggeler KR. 2016. Analysis of Petunia vein clearing virus (PVCV) sequences, retroelements and tandem repeats in Petunia axillaris N and P. inflata S6. Supplementary manuscript 2. Nature Plants 2: article number 16074.

Link to manuscript: Petunia_PVCV_Repeats_SchwarzacherEtAl2016

Within the genome sequence assemblies of P. axillaris (PaxiN) and P. inflata (PinfS6) and unassembled reads, we analysed the occurrence of endogenous Petunia vein clearing virus (PVCV) sequences, other endogenous pararetrovirus (EPRV) sequences, LTR-retroelements, and tandem repeats. Petunia genomes show substantial diversity in their pararetroviral sequences as revealed in searches using the polymerase motif. Homologies to two genera of Caulimoviridae, Petu- and Florendoviruses, with more than 60% amino acid identity, were present in both species. Almost complete PVCV copies, fragments, and degenerate copies, sometimes in tandem arrays, were found. PVCV motifs were more frequent in P. axillaris, with the results seen in the assemblies confirmed by in situ hybridization of PVCV fragments to metaphase chromosomes indicating that P. axillaris is likely a more permissive host for EPRVs. LTR-retroelements are localised near centromeres; about 6500 full length elements were found in the PinfS6 assembly while 4500 were in PaxiN. Apart from rDNA, microsatellites and telomeric sequences, no highly abundant tandem repeats were identified in the assembly or raw reads. Repeat cluster analysis indicates that LTR-retroelements are associated with simple sequence repeats and low complexity DNA families and that repeats within Petunia are very diverse, with none having amplified to form a major proportion of the genome. The repeat landscape of Petunia is different from other species of Solanaceae, in particular the x=12 crown group including Solanum and Nicotiana, with a relative low proportion of total repeats for a genome size of 1.4Gb, x=7, and a high degree of genome plasticity.

Link to manuscript: Petunia_PVCV_Repeats_SchwarzacherEtAl2016

Supplementary manuscript 2 from

325b. Bombarely A, Moser M, Amrad A, Bao M, Bapaume L, Barry CS,  Bliek M, Boersma MR, Borghi L, Bruggmann R, Bucher M, D’Agostino N, Davies K, Druege U, Dudareva N, Egea-Cortines M, Delledonne M, Fernandez-Pozo N, Franken P, Grandont L, Heslop-Harrison JS, Hintzsche J, Johns M, Koes R, Lv X, Lyons E, Malla D, Martinoia E, Mattson NS, Morel P, Mueller LA, Muhlemann J, Nouri E, Passeri V, Pezzotti M, Qi Q, Reinhardt D, Rich M, Richert-Pöggeler KR, Robbins TP, Schatz MC, Schranz ME, Schuurink RC, Schwarzacher T, Spelt K, Tang H, Urbanus S, Vandenbussche M, Vijverberg K, Villarino GH, Warner RM, Weiss J, Yue Z, Zethof J, Quattrocchio F, Sims TL, Kuhlemeier C. 2016. Insight into the evolution of the Solanaceae from the parental genomes of Petunia hybrida. Nature Plants 2: article number 16074. doi:10.1038/nplants.2016.74

http://dx.doi.org/10.1038/nplants.2016.74

 

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Regulation should follow robust scientific assessments not opinions

Risk Delegation with EU Commissioner Vytenis Andriukaitis [From the left: Prof. Richard Sharp (back), Prof. Helmut Greim (middle) ,Prof. Sir Colin Berry (front), Prof. Pat Heslop-Harrison (back), Dr. Vytenis Andriukaitis, Commissioner of Health & Food Safety (middle), Prof. Daniel Dietrich (front), Prof. Wolfgang Dekant (back), and Prof. Alan Boobis (front)]

Risk Delegation with EU Commissioner Vytenis Andriukaitis [From the left: Prof. Richard Sharp (back), Prof. Helmut Greim (middle) ,Prof. Sir Colin Berry (front), Prof. Pat Heslop-Harrison (back), Dr Vytenis Andriukaitis, Commissioner of Health & Food Safety (middle), Prof. Daniel Dietrich (front), Prof. Wolfgang Dekant (back), and Prof. Alan Boobis (front)]

University of Leicester scientist in battle to ‘stem onslaught of pseudoscience’

Geneticist at European Commission alarmed at impact of ‘dogma’ in regulation and the negative impact on the environment and European industry

A University of Leicester scientist has joined leading scientists from across Europe in raising an alarm over the ‘pseudoscience’ concerning regulation of compounds used in agriculture, healthcare and industry.

Professor Pat Heslop-Harrison, from the Department of Genetics, was among scientists meeting Dr Vytenis Andriukaitis, European Commissioner of Health and Food Safety, earlier this month. The scientists highlighted the fact that some people are being ‘deliberately selective’ in presentations of risks, including those from glyphosate herbicides, new plant breeding technologies and endocrine disrupting chemicals or EDCs. Pat Heslop-Harrison brought his knowledge of environmental and agricultural genetics and risk analysis to the meeting, while others in the delegation had particular expertise in toxicology, endocrinology and human pathology. The characterization of risk determines the likelihood that effects will occur under real exposure conditions. For chemicals, whether of natural or synthetic origin, sound regulation requires comparison of exposure with potency, and risk characterization is required to enable the potential benefit of a chemical to be assessed against its potential to inflict harm. Professor Heslop-Harrison was joined by well-established and respected scientists Prof. Sir Colin Berry, Prof. Alan Boobis, Prof. Wolfgang Dekant, Prof. Daniel Dietrich, Prof. Helmut Greim and Prof. Richard Sharpe.

Professor Heslop-Harrison said: “In the discussion, the concern was raised that public perceptions about scientific assessments are currently distorted by people, often from NGOs and well-funded pressure groups, calling for increased regulation or bans. The reality is that there is no robust, consistent scientific evidence to support many of these dogmatic stances, and indeed most of the robust evidence points in the opposite direction for some of the chemicals and techniques now being considered as subject to extra regulation.

“The European Parliament and European Commission have access to robust scientific advice, but this is not always being used in legislation because of these strongly expressed opinions and (sometimes blatantly present) advocacy activities.”

In particular, the scientists in the delegation argued that the presentation of the issues to the public and to the Commission by some groups has been deliberately selective and courses of action have been proposed that are not supported by a scientific evidence base. For EDCs, glyphosate and gene editing techniques for plant breeding for example, the regulation proposed runs counter to the huge database and detailed understanding of all aspects of the substances from their mode of action, to breakdown in the environment, to their effect in humans. The group further highlighted that the current level of knowledge about EDCs and hormone action is such that it allows scientists and the regulatory bodies to identify compounds with potential endocrine activity, natural or synthetic, and to address their potential to cause harm to humans or to the environment via well-established processes.

The group emphasised that management of chemicals and techniques should be based on robust scientific evidence, as is common to all legal procedures (not least including criminal law). This regulation ensure safe use of compounds in a range of applications. In the use of such scientific evidence, this will ensure protection of human health and the environment, while maintaining the sustainability and competitiveness of the European economy.

Pat Heslop-Harrison can be contacted through phh4(a)le.ac.uk or by mobile phone +44/0  7413 292 7five4 .

 

A second press-release from those of us involved in the meeting with Commissioner Andriukaitis is at http://www.prnewswire.co.uk/news-releases/well-known-scientists-ready-to-stem-the-onslaught-of-pseudoscience-in-the-eu-578980091.html

An earlier molcyt.com blogpost is at https://molcyt.org/2016/05/11/scientists-ready-to-stem-the-onslaught-of-pseudoscience-in-the-eu/

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Scientists ready to stem the onslaught of pseudoscience in the EU

EU Commissioner for Health and Food Safety, Vytenis Andriukaitis (left) discussing risk assessment with Pat Heslop-Harrison

EU Commissioner for Health and Food Safety, Dr Vytenis Andriukaitis (left) discussing risk assessment with Pat Heslop-Harrison

BRUSSELS, May 11, 2016 /PRNewswire/

A meeting was held between Dr Vytenis Andriukaitis, Commissioner of Health & Food Safety and well established and respected scientists (Prof. Sir Colin Berry, Prof. Alan Boobis, Prof. Wolfgang Dekant, Prof. Daniel Dietrich, Prof. Helmut Greim, Prof. Pat Heslop-Harrison and Prof. Richard Sharpe) in the fields of human risk assessment and endocrine active compounds (“endocrine disrupting chemicals” or EDCs). Amongst the topics discussed by the group was how the presentation of the issue of EDCs to the public and to the Commission by some scientists has been deliberately selective and has proposed courses of action that: (1) are not supported by a robust scientific evidence base, and (2) run counter to the huge database and detailed understanding of the therapeutic effects of (endocrine active) hormones in human patients. The group emphasized that management of EDCs should be based on robust scientific evidence, as is common to all legal procedures (e.g. criminal law).

In discussion, the concern was raised that public perceptions about EDCs are currently dominated by certain scientists, NGOs and well-funded pressure groups, who categorically assert that EDCs contribute to human cancer, reproductive disorders, obesity and type 2 diabetes. The reality is that there is no robust, consistent scientific evidence to support such a dogmatic stance, and indeed most of the robust evidence points in the opposite direction. The group highlighted that the current level of knowledge about EDC and hormone action is such that it allows scientists and the regulatory bodies to identify compounds with potential endocrine activity and to address their potential to cause harm to humans or to the environment via well-established processes.

Pressure groups have advocated that EDCs should be treated as a “special case” when considering their potential to do harm, on the basis that EDCs (and hormones in general) can have unexpected effects at low level exposures and that they do not have thresholds of effect, with the result that their exposure-response curves are non-monotonic. The reality is that these assumptions are not supported by robust (i.e. reproducible) scientific data and are unlikely to occur in humans, because there is extensive knowledge on the human effects of endocrine active substances from the speciality of clinical endocrinology. Endocrine disorders, extending from diabetes through Graves disease to osteoporosis, that result from hormone levels that are too high or too low are managed by treatment with endocrine-active compounds, which has built a huge level of understanding of the relationships between levels of exposure and resulting health effects in humans. For all of these hormone-mediated functions in humans, thresholds are observed, there are no non-monotonic exposure response curves and no ‘unexpected’ effects at low-level exposures.

In the recent consensus document regarding EDCs developed at the BfR in Berlin (April 12-13, 2016; seehttp://www.bfr.bund.de/en/home.html) it was emphasized that identification of EDCs is only the first step in the risk assessment of EDCs, but that potency and consideration of likely human exposure are necessary for any adequate evaluation of the human or environmental effects of EDCs. As EDCs comprise both natural and synthetic (i.e. manufactured) compounds, sugar in our foods which, when ingested will immediately trigger the release of the hormone insulin, will, if the opinion of some observers is consistently applied, have to be identified as an EDC and be subject to potential regulation. The natural component of sweet mustard (bisphenol F), that has nearly identical endocrine mediated activities as the bisphenol A that was banned from certain uses in France and Germany, would also have to be subject to restriction as would the many estrogenic chemicals present in many plants and vegetables (and presumably thus the plants themselves). This would clearly be nonsensical.

In view of the conclusions reported in the thoughtful consensus document (http://www.bfr.bund.de/en/home.html) and the importance of potency and human exposures in assessing the effects of EDCs, the scientists who met Commissioner Andriukaitis are confident that the current regulatory criteria for all potential EDCs can be developed by the Commission with the input of experienced toxicologists, endocrinologists and risk assessment professionals to enable the safe use of many compounds in a range of applications. In so doing, this will be achieved in a manner that ensures protection of human health and the environment, whilst maintaining the sustainability and competitiveness of the European economy.

From: Concerned Toxicologists for Better Science and Regulation

Contacts:

Prof. Daniel Dietrich, +49-7531-883518, Daniel.Dietrich@uni-konsanz.de, University of Konstanz; Germany

Prof. Helmut Greim, +49-8161-715600, helmut.greim@lrz.tu-muenchen.de, TU Munich, Germany

Prof. Alan Boobis, +44-(0)20-7594-6806, a.boobis@imperial.ac.uk, Imperial College London, UK

Prof. Richard Sharp, +44-(0)131-242-6387, r.sharpe@ed.ac.uk, University of Edinburgh, UK


For environmental and genetic perspective, contact Prof. Pat Heslop-Harrison +44(0) 7413 292 754 phh4@le.ac.uk University of Leicester, UK

Risk Delegation with EU Commissioner Vytenis Andriukaitis [From the left: Prof. Richard Sharp (back), Prof. Helmut Greim (middle) ,Prof. Sir Colin Berry (front), Prof. Pat Heslop-Harrison (back), Dr. Vytenis Andriukaitis, Commissioner of Health & Food Safety (middle), Prof. Daniel Dietrich (front), Prof. Wolfgang Dekant (back), and Prof. Alan Boobis (front)]

Risk Delegation with EU Commissioner Vytenis Andriukaitis [From the left: Prof. Richard Sharp (back), Prof. Helmut Greim (middle) ,Prof. Sir Colin Berry (front), Prof. Pat Heslop-Harrison (back), Dr. Vytenis Andriukaitis, Commissioner of Health & Food Safety (middle), Prof. Daniel Dietrich (front), Prof. Wolfgang Dekant (back), and Prof. Alan Boobis (front)]

 

 

 

 

 
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