17 August 2018
RECORDS MANAGEMENT SECTION
The University of Edinburgh
File ref: T3/26/445
Old College
South Bridge
Edinburgh EH8 9YL
Mr Vincent Harmsen
Direct Dial 0131 651 4099
Sent by email:
request-495644-
Switchboard 0131 650 1000
xxxxxxxx@xxxxxxxxxxxxxx.xxx
Email xxxxxxxxxxxxxxxxx@xx.xx.xx
Dear Mr Harmsen
Your information request
Thank you for your three emails of 4 July 2018 requesting information about
correspondence sent or received by a named member of staff. This letter responds to
your request for correspondence between the member of staff and six other named
individuals and four named organisations between 1 January 2016 and 1 July 2016.
We apologise again for the delay in responding to your request. As previously explained,
we are experiencing a high volume of information requests at this time and a number of
staff absences.
Access to information
As you note in your requests, the correspondence relates to 'endocrine disrupting
chemicals' or 'endocrine active chemicals'. Information about these chemicals and the
regulation of them is environmental information as described in the Environmental
Information (Scotland) Regulations 2004 (EIRs). Therefore we are responding to your
request in line with EIRs rather than freedom of information legislation. In technical terms
this means that the information you requested is exempt under section 39(2) of the
Freedom of Information (Scotland) Act 2002 (FOISA). This exemption is subject to the
public interest test.
The University acknowledges the public interest in openness and transparency,
particularly in relation to the environmental. However, as the public has a statutory right
to access environmental information under EIRs, the University considers the public
interest in withholding this information under FOISA outweighs the public interest in
disclosing it under FOISA.
Correspondence with organisations
You asked for correspondence between Professor Richard Sharpe and the following four
named organisations in between 1 January 2016 and 1 July 2016:
UNIVERSITY SECRETARY Ms Sarah Smith
The University of Edinburgh is a charitable body, registered in Scotland, with registration number SC005336
• European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC)
• European Risk Forum (ERF)
• International Life Sciences Institute (ILSI)
• Health and Environmental Sciences Institute (HESI)
The University has searched its records and it does not hold any information in relation to
this part of your request.
Correspondence with individuals
You asked for correspondence between Professor Richard Sharpe and the following six
named individuals between 1 January 2016 and 1 July 2016:
• Alan Boobis
• Colin Berry
• Pat Heslop-Harrison
• Daniel Dietrich
• Wolfgang Dekant
• Helmut Greim
The University does hold information in relation to this part of your request and I enclose
some of this information.
You will notice that parts of the documents have been redacted. The redactions have
been made either because the correspondence contains individuals’ personal information
or because disclosure would harm the interests of the individuals. I have also removed
any obvious duplicate information that I noticed as I processed the request.
Personal information
Under the Data Protection law, disclosure of personal information must not breach any of
the data protection principles in Article 5(1) of the General Data Protection Regulation
(GDPR). The individuals had no expectation that their correspondence would be
disclosed. Therefore in some cases, disclosing individuals’ personal information,
including their views and opinions, would breach the principles. The Environmental
Information (Scotland) Regulations 2004 does not require us to provide this sort of
information as it is exempt under Regulation 11(2).
Third party interests
In some cases I cannot provide information because doing so would, or be likely to,
cause substantial prejudice to the interests of the individuals who provided the
information voluntarily to the University. The individuals were under no legal obligation to
supply this information, and they have not consented to disclosure. The Environmental
Information (Scotland) Regulations 2004 do not require us to provide this sort of
information as it is exempt under Regulation 10(5)(f).
2
This exemption is subject to the public interest test. There is clear public interest in the
transparent operation of universities, particularly with regard to the role of academic staff
in informing public policy. We are therefore pleased to disclose some of the information
you have requested. However, there is also public interest in ensuring that academic
staff working collaboratively together across different universities can have open and
constructive pre-meeting discussions. The public interest would not be served if
academic staff felt inhibited in doing so for fear that this type of information would be
disclosed against their wishes and contrary to their interests. Therefore the University
considers that the public interest in withholding some of the information outweighs the
public interest in releasing it.
You stated that the individuals were part of a delegation of scientists that met with the EU
Commissioner for Public Health, Vytenis Andriukaitis, in 2016 to discuss the regulation of
'endocrine active chemicals'. You explained that the aim of your request is to create
transparency and reconstruct public policy. I therefore also enclose a paper by the seven
academics who are the focus of your request. The paper states their views on the
subject matter and the same views were communicated to the EU Commissioner.
Discussions about the drafting of the paper and draft versions are included within the
attached correspondence. The paper is publicly available at
https://lra.le.ac.uk/bitstream/2381/38673/2/DietrichHeslopHarrisonEtAlRisk.pdf.
Right to review
If you are dissatisfied with this response, you may ask the University to conduct a review
of this decision by contacting the University's Records Management Section
(www.ed.ac.uk/records-management/about/contact) in writing (e.g. by letter or email) or
in some other recorded form (e.g. audio or video tape). You should describe the original
request, explain your grounds for dissatisfaction, and include an address for
correspondence. You have 40 working days from receipt of this letter to submit a review
request. When the review process has been completed, if you are still dissatisfied, you
may appeal to the Scottish Information Commissioner using the guidance at
www.itspublicknowledge.info/Appeal. If you do not have access to the Internet, please
let me know and I will provide a copy of the relevant web pages.
Privacy notice
The University of Edinburgh's privacy notice, which describes how we use the information
you have supplied about yourself and your request, is available on-line at
Privacy Notice.
Yours sincerely
Ann-Marie Noble
Information Compliance Manager
Enclosure:
1. Paper – “Allowing pseudoscience into EU risk assessment processes is eroding
public trust in science experts and in science as a whole: The bigger picture.
Chemico-Biological Interactions”
2. Correspondence
3
If you require this letter in an alternative format, such as large print or
a coloured background, please contact the Records Management
Section on 0131 651 4099 or email xxxxxxxxxxxxxxxxx@xx.xx.xx
4
326.
Dietrich DR, Dekant W, Greim H, Heslop-Harrison P, Berry C, Boobis A,
Hengstler JG, Sharpe R. 2016.Editorial: Allowing pseudoscience into EU risk
assessment processes is eroding public trust in science experts and in science as a
whole: The bigger picture.
Chemico-Biological Interactions 257: 1-3. 21 July 2016.
http://dx.doi.org/10.1016/j.cbi.2016.07.023
Allowing pseudoscience into EU risk assessment processes is eroding public trust in science
experts and in science as a whole: The bigger picture
Daniel R. Dietrich*, Wolfgang Dekant Helmut Greim Pat Heslop-Harrison Sir Colin Berry,
Alan Boobis, Jan Hengstler and Richard Sharpe
doi:10.1016/j.cbi.2016.07.023
Imagine we are beamed back into the 12th century and are staying overnight at a country
tavern. We by our clothes met with both curiosity and hostility from the tavern regulars. In
the middle of the night we are roughly wakened by the owner and some of his men and
directly accused of having stolen from one of the regulars after first poisoning him. Despite
our protests and the lack of any reasonable proof we are accused of being thieves and
murderers and are subjected to trial by ordeal to prove our innocence.
The trial takes the form of having our hands and feet tied and being thrown into the river; if
we sink and drown we are obviously guilty, however if we float God has recognized our
innocence and lets us live (
judicium Dei). To a scientist, it seems likely we would drown.
Thankfully, over the past 800 years the development of the judicial system has brought us to
the point where an accused is considered innocent until proven guilty. Whether the context is
Criminal, where a “beyond reasonable doubt” standard of proof is required, or Civil, where
the “balance of probability” is the standard, the burden of proof lies with the accusing party,
but in either case is based on objective evidence.
If we were in the tavern now, it would be necessary for the accuser (or his legal
representative) to prove, beyond reasonable doubt in this case, that we had poisoned the man
and stolen the goods from him. In practice, the onus of the demonstration of proof on the
accuser is not restricted to criminal cases but applies to many legal procedures in
democracies.
Unfortunately Europe, in the application of its legislation relating to chemicals, is in danger
of falling back into the medieval approach. The most recent example is the advocacy group-
[1], media- and NGO- [2] driven move to have glyphosate banned, despite solid evidence and
multiple expert assessments [3], [4] and [5] that this herbicide is without risk to consumers
and is the herbicide with the least negative environmental and health impact. The “public” is
being misled by pseudoscientists to believe that the compound is highly dangerous to humans
and the environment, a claim that runs counter to the evidence and to expert (critical)
assessment of that evidence. The media are rife with quotes from poorly informed and often
scientifically less well-informed politicians and others who had analysed their water, urine,
beer, and vegetables and reported trace amounts of glyphosate, four-thousand-fold below
potentially harmful levels for humans [6]. Under this onslaught of misinformation, decision-
makers may prefer to disregard evidence-based data that contradict a precautionary
viewpoint.
In a similarly misleading vein, there have been seemingly endless discussions about
“endocrine disrupters” and their postulated human health effects, based on association
studies. For these to be causal, they require us to accept that extremely low-level exposures
cause effects in humans, whereas most of the experimental data indicate such exposures are
without effect. Most recently, the debate on “endocrine disruptors” has shifted focus to the
concept that doses of these compounds below their ‘no-observed-effect level’ (in animal and
in vitro studies) can cause adverse effects (so-called non-monotonic dose-response curves)
[7], even though the evidence that endocrine systems can be perturbed in this way just does
not exist; indeed, there is ample human data on abnormally low hormone exposures that tell
us this is not how such systems work. However, this detailed evidence is being ignored and
the most prominent proponents of endocrine disruption-mediated human health effects are
now using this to argue that hazard identification alone is necessary for regulatory purposes
[7]. However, hazard characterization, including potency evaluation, and exposure
assessment are the principles on which the protection of humans from adverse effects of
environmental chemicals is undertaken, and has proved to be very effective. This is also the
consensus approach recommended for endocrine disrupters [8]. This is a logical path that
demands detailed evidence gathering and weighing of the science that then forms the basis of
the information on which the legal process is based. Do we want to throw this trusted and
tried process away?
Relying on hazard identification alone relieves the “accusing party” of the burden of proof
(i.e. obtaining the evidence) and allows for endless new allegations of potential effects on
human health, for which evidence is not required – it is simply assumed to be present. We
don’t think that any of us would like our doctors to use similar approaches for looking after
our health; no, doctors want evidence of what is wrong so that they can target it specifically
to restore normal health. The consequences of doing otherwise can be fatal [9]. What about
the wider implications of a hazard-based approach? Will we ban cars or aeroplanes because
they are clearly hazardous, or oxygen and water because they are hazardous to human health?
In this regard, the putative hazard has now changed; now endocrine disrupters are being
advocated as a prime cause for obesity and type II diabetes [10]. How credible is this? We
know that obesity and type II diabetes can often be corrected by reducing appetite, food
intake and additional exercise, difficult though this may be, but what evidence is there that
reducing exposure to so-called endocrine-disrupting ‘obesogens’ can reduce the incidence of
obesity and type II diabetes? There is no such evidence, yet we are asked to believe that
‘obesogens’ are an important human health risk and because of this should be the major focus
of future research and regulation efforts in this area [11]. Like medieval justice, the accusing
(scaremongering) party never faces the consequences of their accusations or allegations. On
the contrary, the accusing party will benefit from the uncertainty introduced. However, any
damages incurred, whether these be to human health, through unintended consequences,
society or the economy [12], are common good and not the responsibility of the accusing
party.
These trends are testimony to the apparent movement to overturn the use of verifiable facts
and evidence-based risk assessment in regulation and politics. Further, they undermine the
concept of burden of proof, central to our judicial systems, developed over the past centuries.
Indeed, arguably, undue emphasis on hazard identification alone has already found its way
into some EU chemicals legislation, ignoring more informative weight of evidence and risk
assessment approaches, based on sound science, that have served society well over the years.
Indeed, it is not merely chemical risk assessment that is currently at stake, it is science as a
whole. Reports of the lack of reproducibility of published scientific findings [13] and public
disagreement among scientists (and pseudoscientists) on the dangers of compounds, despite
good evidence to the contrary, erodes public trust in scientists, and science as a whole – few
without scientific training realize that science progresses by the detection of, and subsequent
elimination of, errors. This is why acting on findings in isolation, all too common an
occurrence today, is an unsound strategy. Perhaps equally important, failure of decision
makers to recognise this, leads to unnecessarily restrictive and potentially damaging
regulation.
Arguments such as those we voice above are now routinely attacked, sometimes with blatant
disregard for the facts and scientific evidence provided, on the basis that ‘this is what the
chemical industry wants, so these authors must be speaking on behalf of that industry’ or
worse ‘these scientist must be paid by industry, thus are corrupt and therefore trivialize
hazards’ [14], [15] and [16]. This is not the case! But such unwarranted accusations of
conflicts of interest in the absence of robust scientific evidence to support their assertions
[17] and [18], have become the mode du jour in such disputes [19]. In some cases, this has
resulted in conflict of interest policies that could lead to an overall lack of scientific balance
among the group of experts considered not to be thus conflicted. A number of NGO’s have an
interest in maintaining public concerns about specific issues, and indeed may rely on such
concerns for charitable donations. Hence, there is a strong motivation to disregard data that
contradicts a precautionary point of view. Regrettably, some scientists appear to put the need
to obtain research funding above the objective appraisal of the evidence. Unlike potential
financial bias, these possible conflicts of interest [19] are rarely considered in such debates.
But these attitudes can distort opinions provided to organisations such as EFSA, WHO,
WHO/IARC, EPA and others. The consequence is that scientific argument and weight of
evidence that might disagree with the initial allegation or accusation, can be undermined.
This process damages the credibility of governmental organizations and the well-developed
processes that are the very foundations of our society and our well-being. Simply following
the discussion on the alleged effects of MMR vaccine on autism provides ample evidence of
this [20].
For sure, the chemical industry has every interest in protecting its products and profits, and
will lobby to this effect. However, to ensure longevity of their products and to avoid
litigation, industry is as interested in an evidence-based approach to risk assessment as we
are, and collecting the evidence is a huge and expensive task that industry has to undertake,
as is mandated by the regulating authorities, to justify the safety of its products. Is it sensible
to say “No” to such evidence and instead to assume that if a chemical is hazardous it should
be banned, irrespective of how low the concentrations are that we, the public, are exposed to?
In essence, we would be saying that an evidence-based approach is not as good as a
presumptive approach based on no evidence. This is to throw away scientific principles and
good practice and to replace it with something akin to witchcraft.
It is time to end the influence of pseudoscience and pseudoscientists, including some self-
appointed public advocacy groups, on European legislation. We advocate this not because of
what the chemical industry may want or not want, but because it is the most credible,
scientifically-sound and societally-beneficial solution, utilising well-defined and transparent
processes of evidence gathering, weighing and risk assessment that should be at the core of
decisions that support all legal procedures. This system is what has been developed, tried and
tested in Europe over the years and is demonstrably protective of human health. Thus this
surely should have been the aim of the European Commission in its decision on the criteria
for EDCs in the regulation of biocides and pesticides [21].
References
[1] A.T.W.I Action, Protect Our Health, Stop Monsanto (2016)
[2] P.A.N. Europe Environmental NGOs Press Charges Against Monsanto German
government institute and European Food Safety Authority (2016)
[3] J. FAO/WHO Pesticide residues in food 2016 J. FAO/WHO (Ed.), Special Session of the
Joint FAO/WHO Meeting on Pesticide Residues, JMPR FAO/WHO (2016), p. 123
[4] B.f. Risikobewertung The BfR Has Finalised its Draft Report for the Re-evaluation of
Glyphosate BfR, Berlin (2015)
[5] E.F.S. Authority Conclusion on the peer review of the pesticide risk assessment of the
active substance glyphosate EFSA J., 13 (2015), pp. 4302–4408
[6] B.f. Risikobewertung Glyphosate in Urine – Concentrations Are Far below the Range
Indicating a Potential Health Hazard Opinion No. 014/2013Berlin (2013)
[7] E. News Society Leaders Help Inform International EDC Regulations (2016)
[8] R. Solecki, A. Kortenkamp, Å. Bergman, I. Chahoud, G.H. Degen, D.R. Dietrich, H.
Greim, H. Håkansson, U. Hass, T. Husoy, M. Jacobs, S. Jobling, A. Mantovani, P. Marx-
Stoelting, A. Piersma, R. Slama, R. Stahlmann, M. van den Berg, R.T. Zoeller, A.R. Boobis
Scientific principles for the identification of endocrine disrupting chemicals – a consensus
statement Environ. Health Perspect. (2016) (in press)
[9] P. Posadzki, A. Alotaibi, E. Ernst Adverse effects of homeopathy: a systematic review of
published case reports and case series. Int. J. Clin. Pract., 66 (2012), pp. 1178–1188
[10] J. Legler, T. Fletcher, E. Govarts, M. Porta, B. Blumberg, J.J. Heindel, L. Trasande
Obesity, diabetes, and associated costs of exposure to endocrine-disrupting chemicals in the
European Union J. Clin. Endocrinol. Metab., 100 (2015), pp. 1278–1288
[11] J.J. Heindel et al. Parma consensus statement on metabolic disruptors Environ. Health,
14 (2015),
p. 54 http://dx.doi.org/10.1186/s12940-015-0042-7
[12] D.R. Dietrich, W. Dekant, H. Greim, P. Heslop-Harrison, C. Berry, A. Boobis, J.
Hengstler, R.M. Sharpe Don’t mar legislation with pseudoscience. Nature, 535 (2016), p. 355
[13] M. Baker 1,500 scientists lift the lid on reproducibility. Nature, 533 (2016), pp. 452–454
[14] J. Garwood Do toxic editors trivialise hidden hazards? Lab. Times, 3 (2014), pp. 39–42
[15] S. Horel A Toxic Affair: Season Finale Corporate Europe Observatory (2016)
[16] S. Horel, B. Bienkowsi Special Report: Scientists Critical of EU Chemical Policy Have
Industry Ties (2013) Environmental Health News
[17] R. Slama, J.P. Bourguignon, B. Demeneix, R. Ivell, G. Panzica, A. Kortenkamp, T.
Zoeller Scientific issues relevant to setting regulatory criteria to identify endocrine disrupting
substances in the European Union Environ. Health Perspect. (2016)
http://dx.doi.org/10.1289/EHP217
[18] P. Grandjean, D. Ozonoff Transparency and translation of science in a modern world
Environ. Health, 12 (2013), p. 70
[19] D.R. Dietrich, J.G. Hengstler Conflict of interest statements: current dilemma and a
possible way forward Arch. Toxicol. (2016)
http://dx.doi.org/10.1007/s00204-016-1783-y
[20] P. Hobson-West ‘Trusting blindly can be the biggest risk of all’: organised resistance to
childhood vaccination in the UK Sociol. Health Illn., 29 (2007), pp. 198–215
[21] E. Commission Press Release 15.06.2016: Commission Presents Scientific Criteria to
Identify Endocrine Disruptors in the Pesticides and Biocides Areas European Commission,
Bruxelles (2016)
*Corresponding author.
Daniel R. Dietrich Human and Environmental Toxicology, University of Konstanz, 78457
Konstanz, Germany
Wolfgang Dekant Department of Toxicology, University of Wuerzburg, Versbacher Str. 9,
97078 Wuerzburg, Germany
Helmut Greim Technical University of Munich, Hohenbachernstr. 15-17, 85354 Freising-
Weihenstephan, Germany
Pat Heslop-Harrison Department of Genetics, University Road, University of Leicester, LE1
7RH, United Kingdom
Sir Colin Berry Queen Mary – Pathology, Queen Mary, London, London E1 4NS, United
Kingdom
Alan Boobis Department of Medicine, Hammersmith Campus, Imperial College London,
London W12 0NN, United Kingdom
Jan Hengstler Department of Toxicology, IfADo, Ardeystrasse 67, 44139 Dortmund,
Germany
Richard Sharpe MRC Centre for Reproductive Health, 47 Little France Crescent, University
of Edinburgh, Edinburgh EH16 4TJ United Kingdom
Available online 21 July 2016
From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
Date: Friday, 1 July 2016 at 08:53
To: "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx>, Daniel Dietrich <Daniel.Dietrich@uni-
konstanz.de>,
Wolfgang Dekant <xxxxxx@xxxx.xxxxxxxxxxxxx.xx>,
'Helmut Greim'
, Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>, "Heslop-
Harrison, Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx>
Subject: Re: GMO
Me also
Richard
From: <Boobis>, Alan R <x.xxxxxx@xxxxxxxx.xx.xx >
Date: Friday, 1 July 2016 08:19
To: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx >,
Wolfgang Dekant
<xxxxxx@xxxx.xxxxxxxxxxxxx.xx >, '
'Helmut Greim'
, Colin Berry
, "Heslop-Harrison, Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx >, Information
Services <x.xxxxxx@xx.xx.xx >
Subject: RE: GMO
Dan
I have signed the petition. Very pleased that this is possible.
Best wishes,
Alan
From: Daniel Dietrich [mailto:xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx ]
Sent: 01 July 2016 08:14
To:
Wolfgang Dekant <xxxxxx@xxxx.xxxxxxxxxxxxx.xx >;
'Helmut Greim'
; Colin Berry
; Heslop-Harrison,
Pat (Prof.) <xxxx@xxxxxxxxx.xx.xx >; SHARPE Richard <x.xxxxxx@xx.xx.xx >; Boobis, Alan R
<x.xxxxxx@xxxxxxxx.xx.xx >
Subject: FW: GMO
Dear colleagues
Best
Dan
Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
Professor of Human and Environmental Toxicology,
Faculty of Biology, University of Konstanz
P.O. Box 622
Universitätsstrasse 10
D-78457 Konstanz, Germany
Telephone:
Portable-Phone:
Fax:
email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
http://www.umwelttoxikologie.uni-konstanz.de
Von:
Datum: Freitag, 1. Juli 2016 02:58
An: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx >
Betreff: GMO
Daniel:
Dear
Sincerely
Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
Professor of Human and Environmental Toxicology,
Faculty of Biology, University of Konstanz
P.O. Box 622
Universitätsstrasse 10
D-78457 Konstanz, Germany
Telephone:
Portable-Phone:
Fax:
email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
http://www.umwelttoxikologie.uni-konstanz.de
--
Prof. Dr. Wolfgang Dekant
Department of Toxicology, University of Wuerzburg
Versb
7078 Wuerzburg, Germany
Tel.
Fax:
Mobil:
From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
Date: Thursday, 16 June 2016 at 10:41
To: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx>
Subject: Re: EDC announcement
Hi Dan
Coi attached.
Good luck
Richard
From: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx >
Date: Wednesday, 15 June 2016 14:14
To: SHARPE Richard <x.xxxxxx@xx.xx.xx >
Cc: Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>,
"Boobis,
Alan R" <x.xxxxxx@xxxxxxxx.xx.xx >, "Greim, Helmut"
, "Heslop-Harrison, Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx >, Wolfgang Dekant
<xxxxxx@xxxx.xxxxxxxxxxxxx.xx >
Subject: Re: EDC announcement
Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
Professor of Human and Environmental Toxicology,
Faculty of Biology, University of Konstanz
P.O. Box 622
Universitätsstrasse 10
D-78457 Konstanz, Germany
Telephone:
Portable-Phone:
Fax:
email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
http://www.umwelttoxikologie.uni-konstanz.de
Von: SHARPE Richard <x.xxxxxx@xx.xx.xx >
Datum: Mittwoch, 15. Juni 2016 14:52
An: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx >, "Greim, Helmut"
, Wolfgang Dekant <xxxxxx@xxxx.xxxxxxxxxxxxx.xx >, "Boobis, Alan R"
<x.xxxxxx@xxxxxxxx.xx.xx >, "Heslop-Harrison, Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx >,
, Colin Berry
Betreff: Re: EDC announcement
Thanks Dan, that’s more or less what I concluded, but I always find such pronouncements to be so
obtuse (because of trying to please and appease all), that I’m never sure that I get the correct message.
What did ring through was the emphasis throughout that scientific method and scientific evidence
would be the drivers, which sounds very Andriukaitis-infuenced (so maybe we had some effect).
Dan, what did you mean by your last sentence?
BW
Richard
From: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx >
Date: Wednesday, 15 June 2016 13:45
To: SHARPE Richard <x.xxxxxx@xx.xx.xx >, "Greim, Helmut"
, Wolfgang Dekant <xxxxxx@xxxx.xxxxxxxxxxxxx.xx >, "Boobis, Alan R"
<x.xxxxxx@xxxxxxxx.xx.xx >, "Heslop-Harrison, Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx >,
Colin Berry
Subject: Re: EDC announcement
Dan
Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
Professor of Human and Environmental Toxicology,
Faculty of Biology, University of Konstanz
P.O. Box 622
Universitätsstrasse 10
D-78457 Konstanz, Germany
Telephone:
Portable-Phone:
Fax:
email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
http://www.umwelttoxikologie.uni-konstanz.de
Von: SHARPE Richard <x.xxxxxx@xx.xx.xx >
Datum: Mittwoch, 15. Juni 2016 14:34
An: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx >, "Greim, Helmut"
, Wolfgang Dekant <xxxxxx@xxxx.xxxxxxxxxxxxx.xx >, "Boobis, Alan R"
<x.xxxxxx@xxxxxxxx.xx.xx >, "Heslop-Harrison, Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx >,
, Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>
Betreff: Re: EDC announcement
I need some of you more used to EC-language to interpret this for me, as it reads a bit self-
contradictorily (to me) - i.e. everyones a winner!
http://europa.eu/rapid/press-release_IP-16-2152_en.htm
The University of Edinburgh is a charitable body, registered in Scotland, with registration number
SC005336.
The University of Edinburgh is a charitable body, registered in Scotland, with registration number
SC005336.
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Statement of Conflicts of Interest
Author Name: __________
Richard _______
Sharpe
Manuscript# _________________
Title___________
Allowing
________________
pseudoscience into EU
______
risk
______
assessment
__________
processes is
______
eroding
___
public
___
trust
__________
in science
______
experts
__
and
____
in
___
science
as a whole
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State Which data: ___________________________________________
Participated in drafting and/or revising the manuscript.
0 20 40 60 80 100%
Was primarily responsible for a particular, specialized role in the research, e.g.
statistical analysis, crystallography, preparation of cell lines; please briefly state
0 20 40 60 80 100%
which: ____________________________________________________
Provided administrative, technical or supervisory support.
0 20 40 60 80 100%
The senior author from each lab or group must answer this question: I have personally checked all the original
data that was generated by my lab or group:
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_______________________________________________________________________.
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Therefore,
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From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
Date: Wednesday, 15 June 2016 at 14:19
To: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx>
Subject: Re: EDC announcement
Dan I sent my COI yesterday, but here it is again.
Richard
From: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx >
Date: Wednesday, 15 June 2016 14:14
To: SHARPE Richard <x.xxxxxx@xx.xx.xx >
Cc: Colin Berry
,
"Boobis,
Alan R" <x.xxxxxx@xxxxxxxx.xx.xx >, "Greim, Helmut"
, "Heslop-Harrison, Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx >, Wolfgang Dekant
<xxxxxx@xxxx.xxxxxxxxxxxxx.xx >
Subject: Re: EDC announcement
Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
Professor of Human and Environmental Toxicology,
Faculty of Biology, University of Konstanz
P.O. Box 622
Universitätsstrasse 10
D-78457 Konstanz, Germany
Telephone:
Portable-Phone:
Fax:
email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
http://www.umwelttoxikologie.uni-konstanz.de
Von: SHARPE Richard <x.xxxxxx@xx.xx.xx >
Datum: Mittwoch, 15. Juni 2016 14:52
An: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx >, "Greim, Helmut"
, Wolfgang Dekant <xxxxxx@xxxx.xxxxxxxxxxxxx.xx >, "Boobis, Alan R"
<x.xxxxxx@xxxxxxxx.xx.xx >, "Heslop-Harrison, Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx >,
, Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>
Betreff: Re: EDC announcement
Thanks Dan, that’s more or less what I concluded, but I always find such pronouncements to be so
obtuse (because of trying to please and appease all), that I’m never sure that I get the correct message.
What did ring through was the emphasis throughout that scientific method and scientific evidence
would be the drivers, which sounds very Andriukaitis-infuenced (so maybe we had some effect).
Dan, what did you mean by your last sentence?
BW
Richard
From: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx >
Date: Wednesday, 15 June 2016 13:45
To: SHARPE Richard <x.xxxxxx@xx.xx.xx >, "Greim, Helmut"
, Wolfgang Dekant <xxxxxx@xxxx.xxxxxxxxxxxxx.xx >, "Boobis, Alan R"
<x.xxxxxx@xxxxxxxx.xx.xx >, "Heslop-Harrison, Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx >,
, Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>
Subject: Re: EDC announcement
Dan
Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
Professor of Human and Environmental Toxicology,
Faculty of Biology, University of Konstanz
P.O. Box 622
Universitätsstrasse 10
D-78457 Konstanz, Germany
Telephone:
Portable-Phone:
Fax:
email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
http://www.umwelttoxikologie.uni-konstanz.de
Von: SHARPE Richard <x.xxxxxx@xx.xx.xx >
Datum: Mittwoch, 15. Juni 2016 14:34
An: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx >, "Greim, Helmut"
, Wolfgang Dekant <xxxxxx@xxxx.xxxxxxxxxxxxx.xx >, "Boobis, Alan R"
<x.xxxxxx@xxxxxxxx.xx.xx >, "Heslop-Harrison, Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx >,
, Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>
Betreff: Re: EDC announcement
I need some of you more used to EC-language to interpret this for me, as it reads a bit self-
contradictorily (to me) - i.e. everyones a winner!
http://europa.eu/rapid/press-release_IP-16-2152_en.htm
The University of Edinburgh is a charitable body, registered in Scotland, with registration number
SC005336.
The University of Edinburgh is a charitable body, registered in Scotland, with registration number
SC005336.
From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
Date: Wednesday, 15 June 2016 at 14:12
To: "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx>, Daniel Dietrich <Daniel.Dietrich@uni-
konstanz.de>, "Greim, Helmut"
, Wolfgang Dekant
<xxxxxx@xxxx.xxxxxxxxxxxxx.xx>, "Heslop-Harrison, Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx>,
Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>
Subject: Re: EDC announcement
I guess that many different things can be read into the wording, and ultimately it will all
depend on what actions result. The battlefield will clearly be on the pesticides/biocides and
what derogations are allowed and what will determine these key decision-points.
In that regard it seems that not much has changed, although the wording may indicate that
derogation may involve more of an uphill battle than beforehand?
I am told by a journalist that environmental groups are ‘already calling foul on the plan’,
but presumably that’s because there is still a theoretical escape door.
Richard
From: "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx >
Date: Wednesday, 15 June 2016 13:52
To: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx >, SHARPE Richard
<x.xxxxxx@xx.xx.xx >, "Greim, Helmut"
, Wolfgang
Dekant <xxxxxx@xxxx.xxxxxxxxxxxxx.xx >, "Heslop-Harrison, Pat (Prof.)"
<xxxx@xxxxxxxxx.xx.xx >,
, Colin Berry
Subject: Re: EDC announcement
I am not so sure that this is good news. More detail can be found
at http://ec.europa.eu/health/endocrine_disruptors/docs/com_2016_350_en.pdf and it is
not encouraging.
Best wishes,
Alan
From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
Date: Tuesday, 14 June 2016 at 11:44
To: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx>, "Boobis, Alan R"
<x.xxxxxx@xxxxxxxx.xx.xx>, "Greim, Helmut"
,
Wolfgang Dekant <xxxxxx@xxxx.xxxxxxxxxxxxx.xx>, "Heslop-Harrison, Pat (Prof.)"
<xxxx@xxxxxxxxx.xx.xx>,
Colin Berry
<xxxxx@xxxxxxxxxxxxx.xx.xx>
Subject: Re: Perspectives / Correspondence for The LAncet
Hi Dan
My COI form also attached.
Thanks for your lead and hard work on this.
BW
Richard
From: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx >
Date: Monday, 13 June 2016 16:13
To: "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx >, "Greim, Helmut"
, Wolfgang Dekant <xxxxxx@xxxx.xxxxxxxxxxxxx.xx >, SHARPE Richard
<x.xxxxxx@xx.xx.xx >, "Heslop-Harrison, Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx >,
, Colin Berry
Subject: Re: Perspectives / Correspondence for The LAncet
All
Dan
Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
Professor of Human and Environmental Toxicology,
Faculty of Biology, University of Konstanz
Universitätsstrasse. 10
D-78457 Konstanz, Germany
Telephone:
Portable-Phone:
Fax:
email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
http://www.umwelttoxikologie.uni-konstanz.de
Von: "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx
>
Datum: Montag, 13. Juni 2016 16:55
An: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
>,
"Greim, Helmut"
,
Wolfgang Dekant <xxxxxx@xxxx.xxxxxxxxxxxxx.xx
>,
SHARPE Richard <x.xxxxxx@xx.xx.xx>, "Heslop-Harrison,
Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx
>,
Colin Berry
<xxxxx@xxxxxxxxxxxxx.xx.xx
>
Betreff: Re: Perspectives / Correspondence for The LAncet
Dan
In the interests of full disclosure, I now try to be comprehensive in such declarations.
Please see attached.
Best wishes,
Alan
From: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx >
Sent: 13 June 2016 15:35
To: Greim, Helmut; Wolfgang Dekant; Boobis, Alan R; SHARPE Richard; Heslop-Harrison, Pat
(Prof.);
; Colin Berry
Subject: FW: Perspectives / Correspondence for The LAncet
Dear all
Dan
Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
Professor of Human and Environmental Toxicology,
Faculty of Biology, University of Konstanz
Universitätsstrasse. 10
D-78457 Konstanz, Germany
Telephone:
Portable-Phone:
Fax:
email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
http://www.umwelttoxikologie.uni-konstanz.de
Von:
Datum: Montag, 13. Juni 2016 15:11
An: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
>
Betreff: RE: Perspectives / Correspondence for The LAncet
Dear Prof. Dietrich,
From: Daniel Dietrich [mailto:xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
]
Sent: 13 June 2016 10:04
To:
Subject: Perspectives / Correspondence for The LAncet
Importance: High
Dan Dietrich
Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
Professor of Human and Environmental Toxicology,
Faculty of Biology, University of Konstanz
Universitätsstrasse. 10
D-78457 Konstanz, Germany
Telephone:
Portable-Phone:
Fax:
email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
http://www.umwelttoxikologie.uni-konstanz.de
From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
Date: Saturday, 11 June 2016 at 22:19
To: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx>, "Boobis, Alan R"
<x.xxxxxx@xxxxxxxx.xx.xx>
Cc: Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>, "Greim, Helmut"
, Wolfgang Dekant <xxxxxx@xxxx.xxxxxxxxxxxxx.xx>, "Heslop-Harrison, Pat
(Prof.)" <xxxx@xxxxxxxxx.xx.xx>,
Subject: Re: in case you've not seen
I'm not suggesting this for inclusion/modification of the editorial/opinion piece, but I
wondered tonight whether we ought not at some stage to pose to journalists the relative
financial impediments that could result from industry getting it wrong with one of their
products (e.g. Because of EDC activity) as opposed to the green/NGO bodies getting it
wrong with their support for widespread banning (or of a specific compound). You don't
need me to tell you the relative sums. I know we touch on this in our editorial, but it is
indirect and very much 'not in your face'. In terms of trying to get across the relative
differences in accountability/cost, it makes no difference to NGOs if they're wrong but
industry would pay a huge price. So the relative importance of 'getting it right' is
completely different.
I shirk from voicing such arguments because it makes you sound like a spokesperson for
industry, but if our editorial does result in the sorts of attacks that we might predict, it
would be one argument to wield in front of a good scientific journalist – ask them to ask
the NGOs how they would make themselves accountable. Indeed, are they accountable in
any way other than to their like-minded supporters? I don't think they are, yet they gets lots
of money form EC.
I'd be interested to hear your experience in such issues and whether this is a weapon to
fight with or one that can only self-harm.
BW
Richard
From: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx>
Date: Saturday, 11 June 2016 19:00
To: "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx >
Cc: Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>, "Greim, Helmut"
, Wolfgang Dekant <xxxxxx@xxxx.xxxxxxxxxxxxx.xx >, Information Services
<x.xxxxxx@xx.xx.xx >, "Heslop-Harrison, Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx >,
Subject: Re: in case you've not seen
Dan
Von meinem iPhone gesendet
Am 11.06.2016 um 18:55 schrieb "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx
>:
Dan
I suggest '....attacked, sometimes with clear ...'
Best wishes,
Alan
Sent from my iPad
On 11 Jun 2016, at 15:46, Daniel Dietrich <Daniel.Dietrich@uni-
konstanz.de> wrote:
Dan
Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
Professor of Human and Environmental Toxicology,
Faculty of Biology, University of Konstanz
P.O. Box 622
Universitätsstrasse 10
D-78457 Konstanz, Germany
Telephone:
Portable-Phone:
Fax:
email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
http://www.umwelttoxikologie.uni-konstanz.de
Von: "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx >
Datum: Samstag, 11. Juni 2016 16:21
An: Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>
Cc: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx >, "Greim,
Helmut"
, Wolfgang Dekant
<xxxxxx@xxxx.xxxxxxxxxxxxx.xx >, SHARPE Richard
<x.xxxxxx@xx.xx.xx >, "Heslop-Harrison, Pat (Prof.)"
<xxxx@xxxxxxxxx.xx.xx >,
Betreff: Re: in case you've not seen
I agree we should not attribute motive. However in several articles in the
press there has been 'clear disregard' for the evidence, as documented in a
number of emails with the journalists in question. This is more than just a
crusade on their part but a wilful misrepresentation of information
provided in advance of publication.
But we should mix up the views of scientists with whom we disagree from
those of journalists sympathetic to these views.
Best wishes,
Alan
Sent from my iPad
On 11 Jun 2016, at 14:58, Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx> wrote:
Let’s not have “malicious” we are expressing opinions
about the motives of others again. What about “with
apparent disregard for the scientific evidence, which has
been carefully considered by those jealous of their
scientific reputation”. Or something like that
Colin
From: Daniel Dietrich [mailto:Daniel.Dietrich@uni-
konstanz.de]
Sent: Saturday, June 11, 2016 2:05 PM
To: Greim, Helmut; Wolfgang Dekant
Cc: Boobis, Alan R; SHARPE Richard; Colin Berry; Heslop-
Harrison, Pat (Prof.);
Subject: Re: in case you've not seen
Dear ALL
Dan
Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
Professor of Human and Environmental Toxicology, Faculty
of Biology, University of Konstanz
P.O. Box 622
Universitätsstrasse 10
D-78457 Konstanz, Germany
Telephone:
Portable-Phone:
Fax:
email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
http://www.umwelttoxikologie.uni-konstanz.de
Am 11.06.2016 12:16 schrieb "Greim, Helmut" unter
Helmut
Am 11.06.2016 09:48, schrieb Wolfgang Dekant:
Dear all,
wd
Am 10.06.16 um 16:03 schrieb Boobis, Alan R:
Richard
I share your feelings on this.
Even more frustrating is that I responded in detail on
a number of
these issues to
and
then went ahead
published
contradictory interpretations anyway. An example is
the claim that
what we presented to the Commissioner
contradicted the Berlin
consensus, yet it was exactly what was in para 24 of
that document,
as agreed by all present.
Best wishes,
Alan
Sent from my iPad
On 10 Jun 2016, at 09:45, SHARPE Richard
<x.xxxxxx@xx.xx.xx > wrote:
Dear fellow grizzleds
It seems increasingly to me, that the 'other camp'
if I can call
them that, not only speak a different language to
any that I
understand, but cannot possibly countenance the
idea that
different scientists may justifiably have different
views, without
this being explained by a devilish conspiracy
(unless there's
something that you other guys are not telling
me!!). It seems to
me that one side is dealing with science the other
with science
fiction, and
is clearly an enthusiast
of the fiction
side. Remarkable but utterly depressing to see
science made to
look so foolish and stupid.
Richard
From: <Boobis>, Alan R
<x.xxxxxx@xxxxxxxx.xx.xx >
Date: Friday, 10 June 2016 13:21
To: Information Services <x.xxxxxx@xx.xx.xx >,
"Greim, Helmut"
, Daniel
Dietrich
<xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx >
Cc: Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>,
"Heslop-Harrison, Pat
(Prof.)" <xxxx@xxxxxxxxx.xx.xx >, Wolfgang
Dekant
<xxxxxx@xxxx.xxxxxxxxxxxxx.xx >,
Subject: Re: in case you've not seen
And for more detail se
http://corporateeurope.org/sites/default/files/attachments/ceo-
edc_addendum-june-5.pdf
[1]
Best wishes,
Alan
-------------------------
FROM: SHARPE Richard <x.xxxxxx@xx.xx.xx >
SENT: 10 June 2016 12:35
TO: Greim, Helmut; Daniel Dietrich
CC: Colin Berry; Boobis, Alan R; Heslop-Harrison,
Pat (Prof.);
Wolfgang Dekant;
SUBJECT: Re: in case you've not seen
https://www.theparliamentmagazine.eu/articles/news/endocrine-
disruptors-com
mission-breach-eu-law-says-parliament
--
The University of Edinburgh is a charitable body,
registered in
Scotland, with registration number SC005336.
--
Prof. Dr. Wolfgang Dekant
Department of Toxicology
University of Wuerzburg
Versbacher Str. 9
97078 Wuerzburg
Tel.:
Fax:
Links:
------
[1]
http://corporateeurope.org/sites/default/files/attachments/ceo-
edc_addendum-june-5.pdf
Dan
Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
Professor of Human and Environmental Toxicology,
Faculty of Biology, University of Konstanz
P.O. Box 622
Universitätsstrasse 10
D-78457 Konstanz, Germany
Telephone:
Portable-Phone:
Fax:
email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
http://www.umwelttoxikologie.uni-konstanz.de
Von: Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>
Datum: Freitag, 10. Juni 2016 06:25
An: "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx >, "Greim, Helmut"
, Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx >
Cc: SHARPE Richard <x.xxxxxx@xx.xx.xx >, "Heslop-Harrison, Pat (Prof.)"
<xxxx@xxxxxxxxx.xx.xx >, Wolfgang Dekant <xxxxxx@xxxx.xxxxxxxxxxxxx.xx >,
Betreff: RE: Editorial on risk and regulation comments
I like Alans bit on conflicts and I agree about salt, as I said before .I don’t think it adds much and
will be picked on by some.
Colin
From: Boobis, Alan R [mailto:x.xxxxxx@xxxxxxxx.xx.xx]
Sent: Thursday, June 9, 2016 10:07 PM
To: Greim, Helmut; Daniel Dietrich
Cc: SHARPE Richard; Colin Berry; Heslop-Harrison, Pat (Prof.); Wolfgang Dekant;
Subject: Re: Editorial on risk and regulation comments
Dan
Building on what has gone before, I am providing some suggestions for the text. In
particular, I have expanded slightly the section on conflict of interest.
Best wishes,
Alan
From: Greim, Helmut
Sent: 09 June 2016 13:23
To: Daniel Dietrich
Cc: Boobis, Alan R; SHARPE Richard; Colin Berry; Heslop-Harrison, Pat (Prof.); Wolfgang Dekant;
Subject: Re: Editorial on risk and regulation comments
Dear all,
Helmut
Am 09.06.2016 13:57, schrieb Daniel Dietrich:
> Dear Alan (and others)
>
> Dan
> Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
> Professor of Human and Environmental Toxicology,
> Faculty of Biology, University of Konstanz
>
> Universitätsstrasse. 10
> D-78457 Konstanz, Germany
>
> Telephone:
>
> Portable-Phone:
> Fax:
> email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
> http://www.umwelttoxikologie.uni-konstanz.de
>
>
>
>
>
>
>
> Am 09.06.16 13:16 schrieb "Boobis, Alan R" unter
> <x.xxxxxx@xxxxxxxx.xx.xx >:
>
>> Dan
>>
>> I am
but will send comments by end of tomorrow at
>> latest.
>>
>> Best wishes,
>>
>> Alan
>>
>> Sent from my iPad
>>
>>> On 9 Jun 2016, at 07:13, Daniel Dietrich
>>> <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx > wrote:
>>>
>>> Hi Richard
>>>
>>> Best
>>> Dan
>>> Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
>>> Professor of Human and Environmental Toxicology,
>>> Faculty of Biology, University of Konstanz
>>>
>>> Universitätsstrasse. 10
>>> D-78457 Konstanz, Germany
>>>
>>> Telephone:
>>>
>>> Portable-Phone:
>>> Fax:
>>> email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
>>> http://www.umwelttoxikologie.uni-konstanz.de
>>>
>>>
>>>
>>>
>>>
>>>
>>>
>>> Am 09.06.16 13:06 schrieb "SHARPE Richard" unter <x.xxxxxx@xx.xx.xx >:
>>>
>>>> Hi Dan and Co
>>>>
>>>> I have to admit that there were a few things in the editorial draft
>>>> that
>>>> came around that I would not like to sign my name to.
>>>> I think it was just too dogmatic and dismissive, especially on the
>>>> ED
>>>> side, and I do not think this would serve us well. I know that Dan
>>>> wants
>>>>> Portable-Phone:
>>>>> Fax:
>>>>> email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
>>>>> http://www.umwelttoxikologie.uni-konstanz.de
>>>>>
>>>>>
>>>>>
>>>>>
>>>>>
>>>>>
>>>>>
>>>>> Am 08.06.2016 15:18 schrieb "Colin Berry" unter
>>>>> <xxxxx@xxxxxxxxxxxxx.xx.xx>:
>>>>>
>>>>>> Daniel,
>>>>>> Another go
>>>>>> I don't go for " accusation"- it's really the" arousal of
>>>>>> suspicion"
>>>>>> and
>>>>>> I think it appears pejorative as it is now. We want to argue for
>>>>>> science,
>>>>>> not opinion
>>>>>> For the same reason, I do not care for "denunciation" later on
>>>>>> which
>>>>>> is
>>>>>> why I used colour - what is happening is a malign influence on
>>>>>> the
>>>>>> quality of debate.
>>>>>> Regards
>>>>>> Colin.
>>>>>>
>>>>>> -----Original Message-----
>>>>>> From: Daniel Dietrich [mailto:xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx ]
>>>>>> Sent: Wednesday, June 8, 2016 11:02 AM
>>>>>> To: Heslop-Harrison, Pat (Prof.); Wolfgang Dekant; Colin Berry;
>>>>>> SHARPE
>>>>>> Richard; 'Boobis, Alan R'; Greim, Helmut;
>>>>>> Subject: Re: Editorial on risk and regulation comments
>>>>>>
>>>>>> Dear Colin, Wolfgang, Pat, Helmut, Jan, Alan and Richard
Dan
>>>>>>
Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
>>>>>>
>>>>>> Professor of Human and Environmental Toxicology, Faculty of
>>>>>> Biology,
>>>>>> University of Konstanz P.O. Box 622 Universitätsstrasse 10
>>>>>> D-78457 Konstanz, Germany
>>>>>>
>>>>>> Telephone:
>>>>>>
,
>>>>>> Secretary)
>>>>>> Portable-Phone:
>>>>>> Fax:
>>>>>> email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
>>>>>> http://www.umwelttoxikologie.uni-konstanz.de
>>>>>>
>>>>>>
>>>>>>
>>>>>>
>>>>>>
>>>>>>
>>>>>>
>>>>>> Am 08.06.2016 09:28 schrieb "Heslop-Harrison, Pat (Prof.)" unter
>>>>>> <xxxx@xxxxxxxxx.xx.xx >:
>>>>>>
>>>>>>> Dear All,
>>>>>>>
.
>>>>>>>
>>>>>>>
>>>>>>> Pat.
>>>>>>>
>>>>>>> Pat Heslop-Harrison.
>>>>>>>
>>>>>>> Professor J.S. (Pat) Heslop-Harrison
>>>>>>> Department of Genetics
>>>>>>> University of Leicester
>>>>>>> Leicester LE1 7RH UK
>>>>>>>
>>>>>>> E-mail: xxxx@xx.xx.xx
>>>>>>>
>>>>>>> Annals of Botany blog: www.AoBBlog.com
>>>>>>> Websites: www.molcyt.com
Chief Editor,
>>>>>>> Annals of
>>>>>>> Botany: www.annbot.com
>>>>>>>
>>>>>>> Phone:
>>>>>>> Mobile phone:
>>>>>>> FAX:
>>>>>>>
>>>>>>> ________________________________________
>>>>>>> From: Wolfgang Dekant [xxxxxx@xxxx.xxxxxxxxxxxxx.xx ]
>>>>>>> Sent: 08 June 2016 08:00
>>>>>>> To: Colin Berry; Daniel Dietrich; Heslop-Harrison, Pat (Prof.);
>>>>>>> SHARPE
>>>>>>> Richard; 'Boobis, Alan R'; Greim, Helmut; Jan Hengstler
>>>>>>> Subject: Re: Commissioner Andriukaitis statement on glyphosate
>>>>>>>
>>>>>>> Hi,
>>>>>>>
>>>>>>>
>>>>>>> wd
>>>>>>>
>>>>>>>
>>>>>>> wd
>>>>>>>
>>>>>>>
>>>>>>>> Am 08.06.16 um 08:37 schrieb Colin Berry:
>>>>>>>> Dear Dnaiel,
>>>>>>>> I hope you do not mind my having a go at this - I enjoyed
>>>>>>>> the
>>>>>>>> tavern idea.
>>>>>>>> There are a number of changes that are trivial but which I
>>>>>>>> hope increase the pithiness of the commentary . For example , I
>>>>>>>> have
>>>>>>>> replaced "lack of any" evidence with "no" and so on - in a
>>>>>>>> tavern
>>>>>>>> (pub) they are usually "regulars" rather than locals in the
>>>>>>>> vernacular. "Medially" does not mean of the media but towards
>>>>>>>> the
>>>>>>>> middle.
>>>>>>>> But some more important bits. I have commented on standards
>>>>>>>> of
>>>>>>>> proof. Criminal standards are not usually invoked in regulation
>>>>>>>> -
>>>>>>>> you
>>>>>>>> don't have to like Godell's mathematics or be a Popperian to
>>>>>>>> know
>>>>>>>> that
>>>>>>>> something in science may be true or false, despite the evidence
>>>>>>>> in
>>>>>>>> its
>>>>>>>> favour so far. Introducing the "balance of probabilities"
>>>>>>>> concept
>>>>>>>> ,
>>>>>>>> as in civil law, means you must consider the weight of evidence
>>>>>>>> -
>>>>>>>> that
>>>>>>>> is what we want. The judicial system have not improved only
>>>>>>>> because of
>>>>>>>> science so I modified this.
>>>>>>>> Is there a better example than salt - or do we need this
>>>>>>>> bit?
>>>>>>>> I am concerned , as I have said before, about attributing
>>>>>>>> motives to others, even if we believe the accusations to be
>>>>>>>> true.
>>>>>>>> SO I
>>>>>>>> would not go on about Monsanto or glyphosate. If you feel it
>>>>>>>> needs
>>>>>>>> ot
>>>>>>>> be in , can I work on it a bit?
>>>>>>>> Celeste Condit wrote very well on who is the "public" and
>>>>>>>> who
>>>>>>>> appoints themselves to speak for them; I wil hunt our t some
>>>>>>>> refs
>>>>>>>> which might be useful.
>>>>>>>> Again, apologies for treading on toes - this is meant to help.
>>>>>>>> Best wishes
>>>>>>>> Colin
>>>>>>>>
>>>>>>>> Ps Not all public advocacy groups are bad.
>>>>>>>>
>>>>>>>> -----Original Message-----
>>>>>>>> From: Daniel Dietrich [mailto:xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx ]
>>>>>>>> Sent: Tuesday, June 7, 2016 6:28 PM
>>>>>>>> To: Heslop-Harrison, Pat (Prof.); Colin Berry; SHARPE Richard;
>>>>>>>> 'Boobis, Alan R'; Greim, Helmut; Wolfgang Dekant;
>>>>>>>> Subject: Re: Commissioner Andriukaitis statement on glyphosate
>>>>>>>> Importance: High
>>>>>>>>
>>>>>>>> Dear all
>>>>>>>> Dan
>>>>>>>> Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
>>>>>>>>
>>>>>>>> Professor of Human and Environmental Toxicology, Faculty of
>>>>>>>> Biology,
>>>>>>>> University of Konstanz P.O. Box 622 Universitätsstrasse 10
>>>>>>>> D-78457 Konstanz, Germany
>>>>>>>>
>>>>>>>> Telephone:
>>>>>>>>
>>>>>>>> Secretary)
>>>>>>>> Portable-Phone:
>>>>>>>> Fax:
>>>>>>>> email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
>>>>>>>> http://www.umwelttoxikologie.uni-konstanz.de
>>>>>>>>
>>>>>>>>
>>>>>>>>
>>>>>>>>
>>>>>>>>
>>>>>>>>
>>>>>>>>
>>>>>>>> Am 05.06.2016 22:42 schrieb "Heslop-Harrison, Pat (Prof.)" unter
>>>>>>>> <xxxx@xxxxxxxxx.xx.xx >:
>>>>>>>>
>>>>>>>>> Dear All,
>>>>>>>>>
>>>>>>>>>
>>>>>>>>> Best wishes,
>>>>>>>>>
>>>>>>>>> Pat.
>>>>>>>>>
>>>>>>>>> Professor J.S. (Pat) Heslop-Harrison Department of Genetics
>>>>>>>>> University of Leicester Leicester LE1 7RH UK
>>>>>>>>>
>>>>>>>>> E-mail: xxxx@xx.xx.xx
>>>>>>>>>
>>>>>>>>> Annals of Botany blog: www.AoBBlog.com
>>>>>>>>> Websites: www.molcyt.com
') Chief Editor,
>>>>>>>>> Annals
>>>>>>>>> of
>>>>>>>>> Botany: www.annbot.com
>>>>>>>>>
>>>>>>>>> Phone:
>>>>>>>>> Mobile phone:
>>>>>>>>> FAX:
>>>>>>>
>>>>>>> --
>>>>>>> Prof. Dr. Wolfgang Dekant
>>>>>>> Department of Toxicology, University of Wuerzburg Versbacher Str.
>>>>>>> 9,
>>>>>>> 97078 Wuerzburg, Germany Tel.
>>>>>>> Fax:
>>>>>>> Mobil:
>>>> --
>>>> The University of Edinburgh is a charitable body, registered in
>>>> Scotland, with registration number SC005336.
>>>
>>>
Editorial:
Al owing pseudoscience into EU risk assessment processes is eroding public trust in science
experts and in science as a whole
Daniel R. Dietrich, Wolfgang Dekant, Helmut Greim, Pat Henslop-Harrison, Colin Berry, Alan
Boobis, Jan Hengstler and Richard Sharpe.
Imagine we are beamed back into the 12th century and are staying overnight at a
country tavern. Based on our clothes we are easily identified as foreigners and are
confronted not only with curiosity but also hostility from the tavern regulars. In the middle
of the night we are roughly wakened by the owner and some of his men and directly
accused of having stolen from one of the regulars after first poisoning him. Despite our
protests and the lack of any reasonable proof we are accused of being thieves and
murderers and are subjected to trial by ordeal to prove our innocence.
The trial takes the form of having our hands and feet tied and being thrown into the
river; if we sink and drown we are obviously guilty, however if we float God has recognized
our innocence and let us live
(judicium Dei). To a scientist, it seems likely we would drown.
Thankfully, over the past 800 years the development of the judicial system has
brought us to the point where an accused is considered innocent until proven guilty.
Whether the context is Criminal, where a “beyond reasonable doubt” standard of proof is
required, or Civil, where the “balance of probability” is the standard, the burden of proof
lies with the accusing party.
With us, in the tavern it would be necessary for the accuser (or his legal
representative) to prove, beyond reasonable doubt in this case, that we had poisoned the
man and stolen the goods from him. In practice, the onus of the demonstration of proof on
the accuser is not restricted to criminal cases but applies to many legal procedures in
democracies.
Unfortunately Europe, in the application of its legislation relating to chemicals, is in
danger of falling back into the medieval approach. The most recent example is the advocacy
group- {Action, 2016 #45}, media- and NGO- {Europe, 2016 #46} driven move to have
glyphosate banned, despite solid evidence and multiple expert assessments {FAO/WHO,
2016 #40;Risikobewertung, 2015 #41;Authority, 2015 #42} that this herbicide is without risk
to consumers and is the herbicide with the least negative environmental and health impact.
The “public” is being misled by pseudoscientists to believe that the compound is highly
dangerous to humans and the environment, a claim that runs counter to the evidence and
to expert (critical) assessment of that evidence. The media are rife with quotes from poorly
informed and often scientifically less well-informed politicians and others who had analysed
their water, urine, beer, and vegetables and found trace amounts of glyphosate
{Risikobewertung, 2013 #47}, several orders of magnitude below those that would be
associated with any harm.
In a similarly misleading vein, there have been seemingly endless discussions about
“endocrine disrupters” and their postulated human health effects, based on association
studies. For these to be causal, they require us to accept that extremely low-level exposures
cause effects in humans, whereas most of the experimental data indicate such exposures
are without effect. Most recently, the debate on “endocrine disruptors” has shifted focus to
the concept that doses of these compounds below their ‘no-observed-effect level’ (in
animal and in vitro studies) can cause adverse effects (so-called non-monotonic dose-
response curves) {News, 2016 #44}, even though the evidence that endocrine systems can
be perturbed in this way just does not exist; indeed, there is ample human data on
abnormally low hormone exposures that tell us this is not how such systems work. However,
this detailed evidence is being ignored and the most prominent proponents of endocrine
disruption-mediated human health effects are now using this to argue that hazard
identification alone is necessary for regulatory purposes {News, 2016 #44}. However, hazard
characterization, including potency evaluation, and exposure assessment are the principles
on which the protection of humans from adverse environmental chemical effects is
undertaken, and has proved to be very effective. This is also the approach recommended for
endocrine disrupters {Solecki, 2016 #54}. This is a logical path that demands detailed
evidence gathering and weighing of the science that then forms the basis of the information
on which the legal process is based. Do we want to throw this trusted and tried process
away? Relying on hazard identification alone relieves the “accusing party” of the burden of
proof (i.e. obtaining the evidence) and al ows for endless new al egations of potential effects
on human health, for which evidence is not required – it is simply assumed. We don’t think
that any of us would like our doctors to use similar approaches for looking after our health;
no, doctors want evidence of what is wrong so that they can target it specifical y to restore
normal health. What about the wider implications of a hazard-based approach? Will we ban
cars because they are clearly hazardous, or sugar because it can be hazardous to human
health? In this regard, the putative hazard has now changed; now endocrine disrupters are
being advocated as a prime cause for obesity and type II diabetes {Legler, 2015 #15}. How
credible is this? We know that obesity and type II diabetes can often be corrected by
reducing appetite, food intake and additional exercise, difficult though this may be, but
what evidence is there that reducing exposure to so-called endocrine-disrupting ‘obesogens’
can reduce the incidences of obesity and type II diabetes? There is no such evidence, yet we
are asked to accept that ‘obesogens’ are an important human health risk. Like medieval
justice, the accusing party never faces the consequences of their accusations or al egations.
Any damages incurred, whether these be to human health through unintended
consequences, society or the economy, are common good and not the responsibility of the
accusing party.
These trends are testimony to the apparent movement to overturn the use of
evidence-based risk assessment in regulation. Further, they undermine the concept of
burden of proof, central to our judicial systems, developed over the past centuries. Indeed,
arguably, undue emphasis on hazard identification alone has already found its way, into
some EU chemicals legislation, ignoring more informative weight of evidence and risk
assessment approaches, based on sound science, that have served society wel over the
years. Indeed, it is not merely chemical risk assessment that is currently at stake, it is
science as a whole. Reports of the lack of reproducibility of published scientific findings
{Baker, 2016 #51} and public disagreement among scientists (and pseudoscientists) on the
dangers of compounds, despite good evidence to the contrary, erodes public trust in science
and scientist as a whole – few without scientific training realize that science progresses by
the detection of, and subsequent elimination of, errors. Perhaps equal y important, failure
of decision makers to recognise this leads to unnecessarily restrictive and potentially
damaging regulation.
Arguments such as those we voice above are now routinely attacked on the basis
that ‘this is what the chemical industry wants, so these authors must be speaking on behalf
of that industry’ {Garwood, 2014 #7;Horel, 2016 #52;Horel, 2013 #5}; {Garwood, 2014
#7;Horel, 2016 #52;Horel, 2013 #5}. Tthis is not the case. But such unwarranted accusations
of conflicts of interest in the absence of robust scientific evidence to support their
assertions {Slama, 2016 #48;Grandjean, 2013 #6}, have become the mode du jour in such
disputes. In some cases, this has resulted in conflict of interest policies that could lead to an
overal lack of scientific balance among the group of experts considered not to be thus
conflicted. A number of NGO’s have an interest in maintaining public concerns about
specific issues, and indeed may rely on such concerns for charitable donations. Hence, there
is a strong motivation to disregard data that contradicts a precautionary point of view.
Regrettably, some scientists appear to put the need to obtain research funding above the
objective appraisal of the evidence. Unlike potential financial bias, these possible conflicts of
interest {Dietrich, 2016 #53} are rarely considered in such debates. But these attitudes can
distort opinions provided to organisations such as EFSA, WHO, EPA and others. The
consequence is that scientific argument and weight of evidence brought forth that might
disagree with the initial allegation or accusation can be undermined. This process damages
the credibility of governmental organizations and the well-developed processes that are the
very foundations of our society and our wel -being. For sure, the chemical industry has every
interest in protecting its products and profits, and wil lobby to this effect. To ensure
longevity of their products and to avoid litigation, industry is as interested in an evidence-
based approach to risk assessment as we are, and collecting the evidence is a huge and
expensive task that industry has to undertake to justify the safety of its products. Is it
sensible to say No to such evidence and instead to assume that if a chemical is hazardous it
should be banned, irrespective of how much we, the public, are exposed to? In essence, we
would be saying that an evidence-based approach is not as good as a presumptive approach
based on no evidence. This is to throw away scientific principles and good practice and to
replace it with something akin to witchcraft.
It is time to end the influence of pseudoscience and pseudoscientists, including some
self-appointed public advocacy groups, on European legislation. We advocate this not
because of what the chemical industry may want or not want, but because it is the most
credible, scientifically-sound and societally-beneficial solution, utilising well-defined and
transparent processes of evidence gathering, weighing and risk assessment that should be
at the core of decisions that support all legal procedures. This is what has been developed,
tried and tested in Europe over the years and is demonstrably protective of human health.
References:
Date: Thu, 26 May 2016 12:22:27 +0100
Subject: Re: reproducibility.......or not
From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
To: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx>,
"Heslop-Harrison, Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx>,
"'Boobis, Alan R'" <x.xxxxxx@xxxxxxxx.xx.xx>,
"Greim, Helmut"
,
Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>,
Wolfgang Dekant <xxxxxx@xxxx.xxxxxxxxxxxxx.xx>,
>I’m sure we can all identify with this.
NEWS FEATURE
a replication study. When work does not reproduce, researchers people mentioned this strategy. One who did was Hanne Watkins, a
often assume there is a perfectly valid (and probably boring) reason. graduate student studying moral decision-making at the University
What’s more, incentives to publish positive replications are low and of Melbourne in Australia. Going back to her original questions after
journals can be reluctant to publish negative findings. In fact, several col ecting data, she says, kept her from going down a rabbit hole. And
respondents who had published a failed replication said that editors the process, although time consuming, was no more arduous than
and reviewers demanded that they play down comparisons with the getting ethical approval or formatting survey questions. “If it’s built
original study.
in right from the start,” she says, “it’s just part of the routine of doing
Nevertheless, 24% said that they had been able to publish a success- a study.”
ful replication and 13% had published a failed replication. Acceptance
was more common than persistent rejection: only 12% reported being THE CAUSE
unable to publish successful attempts to reproduce others’ work; 10% The survey asked scientists what led to problems in reproducibility.
reported being unable to publish unsuccessful attempts.
More than 60% of respondents said that each of two factors — pressure
Survey respondent Abraham Al-Ahmad at the Texas Tech University to publish and selective reporting — always or often contributed. More
Health Sciences Center in Amaril o expected a “cold and dry rejection” than half pointed to insufficient replication in the lab, poor oversight
when he submitted a manuscript explaining
or low statistical power. A smaller propor-
why a stem-cell technique had stopped work-
tion pointed to obstacles such as variability in
ing in his hands. He was pleasantly surprised
reagents or the use of specialized techniques
when the paper was accepted3. The reason, he
that are difficult to repeat.
“REPRODUCIBILITY
thinks, is because it offered a workaround for
But all these factors are exacerbated
the problem.
by common forces, says Judith Kimble, a
Others place the ability to publish replica-
developmental biologist at the University of
IS LIKE BRUSHING
tion attempts down to a combination of luck,
Wisconsin–Madison: competition for grants
persistence and editors’ inclinations. Survey
and positions, and a growing burden of
respondent Michael Adams, a drug-develop-
bureaucracy that takes away from time spent
YOUR TEETH. ONCE
ment consultant, says that work showing severe
doing and designing research. “Everyone is
flaws in an animal model of diabetes has been
stretched thinner these days,” she says. And
rejected six times, in part because it does not
the cost extends beyond any particular research
YOU LEARN IT, IT
reveal a new drug target. By contrast, he says,
project. If graduate students train in labs where
work refuting the efficacy of a compound to
senior members have little time for their
treat Chagas disease was quickly accepted4.
juniors, they may go on to establish their own
BECOMES A HABIT.” labs without having a model of how training
THE CORRECTIVE MEASURES
and mentoring should work. “They will go
One-third of respondents said that their labs had taken concrete steps off and make it worse,” Kimble says.
to improve reproducibility within the past five years. Rates ranged from
a high of 41% in medicine to a low of 24% in physics and engineering. WHAT CAN BE DONE?
Free-text responses suggested that redoing the work or asking someone Respondents were asked to rate 11 different approaches to improving
else within a lab to repeat the work is the most common practice. Also reproducibility in science, and all got ringing endorsements. Nearly 90%
common are efforts to beef up the documentation and standardization — more than 1,000 people — ticked “More robust experimental design”
of experimental methods.
“better statistics” and “better mentorship”. Those ranked higher than
Any of these can be a major undertaking. A biochemistry graduate the option of providing incentives (such as funding or credit towards
student in the United Kingdom, who asked not to be named, says that tenure) for reproducibility-enhancing practices. But even the lowest-
efforts to reproduce work for her lab’s projects doubles the time and ranked item — journal checklists — won a whopping 69% endorsement.
materials used — in addition to the time taken to troubleshoot when
The survey — which was e-mailed to
Nature readers and advertised
some things invariably don’t work. Although replication does boost on affiliated websites and social-media outlets as being ‘about reproduc-
confidence in results, she says, the costs mean that she performs checks ibility’ — probably selected for respondents who are more receptive to
only for innovative projects or unexpected results.
and aware of concerns about reproducibility. Nevertheless, the results
Consolidating methods is a project unto itself, says Laura Shankman, suggest that journals, funders and research institutions that advance
a postdoc studying smooth muscle cells at the University of Virginia, policies to address the issue would probably find cooperation, says John
Charlottesville. After several postdocs and graduate students left her lab Ioannidis, who studies scientific robustness at Stanford University in
within a short time, remaining members had trouble getting consist- California. “People would probably welcome such initiatives.” About 80%
ent results in their experiments. The lab decided to take some time off of respondents thought that funders and publishers should do more to
from new questions to repeat published work, and this revealed that lab improve reproducibility.
protocols had gradual y diverged. She thinks that the lab saved money
“It’s healthy that people are aware of the issues and open to a range of
overall by getting synchronized instead of troubleshooting failed experi- straightforward ways to improve them,” says Munafo. And given that
ments piecemeal, but that it was a long-term investment.
these ideas are being widely discussed, even in mainstream media, tack-
Irakli Loladze, a mathematical biologist at Bryan College of Health ling the initiative now may be crucial. “If we don’t act on this, then the
Sciences in Lincoln, Nebraska, estimates that efforts to ensure repro- moment will pass, and people will get tired of being told that they need
ducibility can increase the time spent on a project by 30%, even for his to do something.” SEE EDITORIAL P.437
theoretical work. He checks that all steps from raw data to the final fig-
ure can be retraced. But those tasks quickly become just part of the job.
Monya Baker writes and edits for Nature
from San Francisco.
“Reproducibility is like brushing your teeth,” he says. “It is good for you,
Dan Penny aided in creation and analysis of the survey.
but it takes time and effort. Once you learn it, it becomes a habit.”
One of the best-publicized approaches to boosting reproducibility 1. Open Science Collaboration
Science http://dx.doi.org/10.1126/science.aac4716
(2015).
is pre-registration, where scientists submit hypotheses and plans for 2. Begley, C. G. & Ellis, L. M.
Nature 483, 531–533 (2012).
data analysis to a third party before performing experiments, to prevent 3. Patel, R. & Alahmad, A. J.
Fluids Barriers CNS 13, 6 (2016).
4. da Silva, C. F.
et al. Antimicrob. Agents Chemother. 57, 5307–5314
cherry-picking statistical y significant results later. Fewer than a dozen
(2013).
4 5 4 | N A T U R E | V O L 5 3 3 | 2 6 M A Y 2 0 1 6
© 2 0 1 6 M a c m i l a n P u b l i s h e r s L i m i t e d . A l r i g h t s r e s e r v e d .
>>>>> speak
>>>>> to
>>>>> both sides (industry and NGOs such as ChemTrust) as to speak to one
>>>>> only
>>>>> is to lay oneself open to influence and
I said that the EDC brigade only speak to each other
>>>>> and
>>>>> will
>>>>> not countenance any data that does not fit with their view. I
>>>>> specifically
>>>>> asked
'So, do you think that scientific experts should not speak
>>>>> to
>>>>> industry - that we should withhold our information and expertise?',
>>>>> and
>>>>>
So there
>>>>> we
>>>>> have it - we will be attacked and pilloried on such grounds.
>>>>>
>>>>> I think that when this comes back to bite us, we should ask
>>>>> journalists
>>>>> the question that I asked
. And suggest that they ask their
>>>>> reading
>>>>> public the same question, couched slightly differently such as ' Do
>>>>> you
>>>>> think we would be safer if the chemical/other industry regularly
>>>>> spoke
>>>>> to
>>>>> independent scientific experts or would we be safer if these experts
>>>>> refused to speak to industry to advise them?'Because, in essence
>>>>> that
>>>>> is
>>>>> what this journalist is implying.
>>>>>
>>>>> It's a sad day for science when it is not the evidence that calls
>>>>> the
>>>>> tune
>>>>> but conspiracy theorists speaking on behalf of believers.
>>>>>
>>>>> Sorry to be the bringer of bad news.
>>>>>
>>>>> Richard
>>>>>
>>>>>
>>>>> --
>>>>> The University of Edinburgh is a charitable body, registered in
>>>>> Scotland, with registration number SC005336.
>>>>>
>>>
>>> --
>>> Prof. Dr. Wolfgang Dekant
>>> Department of Toxicology, University of Wuerzburg
>>> Versbacher Str. 9, 97078 Wuerzburg, Germany
>>> Tel.
>>> Fax:
>>> Mobil:
>>>
From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
Date: Monday, 16 May 2016 at 19:06
To: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx>, Wolfgang Dekant <xxxxxx@xxxx.xxx-
wuerzburg.de>, Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>, Alan R Boobis
<x.xxxxxx@xxxxxxxx.xx.xx>, Pat Heslop-Harrison <xxxx@xxxxxxxxx.xx.xx>
Subject: FW: Homeopaths and arsenic-Joe Schwarcz's the Right Chemistry
From:
Date: Monday, 16 May 2016 17:56
To:
Subject: Homeopaths and arsenic-Joe Schwarcz's the Right Chemistry
The Right Chemistry:
Adult colouring books
beat homeopathy any
day
J O E S C H W A R C Z , S P E C I A L T O T H E M O N T R E A L G A Z E T T E
Published on: May 14, 2016 | Last Updated: May 14, 2016 9:58 AM EDT
During a recent talk on the relationship between the body and
the mind, I mentioned the newest anxiety-relieving craze,
colouring books. Aimed at adults, these feature intricate
patterns, making it quite a challenge to stay inside the lines.
The contention is that focusing on the special patterns
distracts the mind from anxiety and stress. Evidence is
sketchy, but millions of colouring books are flying off the
shelves, topping best-seller lists. That in itself says something
about our society.
After my talk, I was approached by a woman who claimed she had something better
than colouring books to relieve anxiety, and slipped a vial full of pills into my hand. She
didn’t seem like a clandestine drug pusher, so I thought I would look down and find
some pills of lorezapam or maybe St. John’s Wort. Such was not the case. The label on
the vial read “Arsenicum album 30C.”
No, she was not trying to poison me. These were homeopathic arsenic pills based on
the curious notion that a substance that in large doses causes certain symptoms can, in
homeopathic potency, repel the same symptoms. Since arsenic poisoning is associated
with anxiety and restlessness, a person suffering such symptoms should find relief in a
homeopathic dose of arsenic. In the bizarre world of homeopathy, potency increases
with greater dilution, and a dose of 30C is said to be extremely potent. Such a pill is
made by sequentially diluting a solution of arsenic 100-fold 30 times and then
impregnating a sugar pill with a drop of the resulting solution. At a dilution of 30C, not
only is there no trace of arsenic left, there isn’t even a water molecule that has ever
encountered any of the original arsenic.
Homeopathy is a scientifically bankrupt practice that was invented more than 200 years
ago by German physician Samuel Hahnemann, who was disenchanted with bloodletting
and purging, common medical procedures at the time. He was a good man who
searched for kinder and gentler treatments, and homeopathy fit that rubric. Since
knowledge of molecules was almost non-existent at the time, Hahnemann could not
have realized that his diluted solutions contained nothing. Actually, the truth is that they
did contain something. A hefty dose of placebo!
Now here is the kicker to this story. Hahnemann was quite accomplished in chemistry
and actually developed the first chemical test for arsenic. In 1787, he found that arsenic
in an unknown sample was converted to an insoluble yellow precipitate of arsenic
trisulfide on treatment with hydrogen sulfide gas. When in 1832 John Bodle in England
was accused of poisoning his grandfather by putting arsenic in his coffee, John Marsh,
a chemist at the Royal Arsenal, was asked to test a sample of the coffee. While he was
able to detect arsenic in the coffee using Hahnemann’s test, the experiment could not
be reproduced to the satisfaction of the jury and Bodle was acquitted. Knowing that he
could not be tried for the same crime again, he later admitted to killing his grandfather.
The confession infuriated Marsh and motivated him to develop a better test for arsenic.
By 1836, he had discovered that treating a sample of body fluid or tissue with zinc and
an acid converted any arsenic to arsine gas, AsH3, which could then be passed through
a flame to yield metallic arsenic and water. The arsenic would then form a silvery-black
deposit on a cold ceramic bowl held in the jet of the flame and the amount of arsenic in
the original sample could be determined by comparing the intensity of the deposit with
that produced with known amounts of arsenic.
The Marsh test received a great deal of publicity in 1840 when Marie LaFarge in France
was accused of murdering her husband by putting arsenic into his food. LaFarge was
known to have bought arsenic from a local chemist, which she claimed was to kill rats
that had infested the house. A maid swore that she has seen her mistress pour a white
powder into her husband’s drink and LaFarge had also sent a cake to her husband, who
was travelling on business just prior to his becoming ill. The dead husband’s family
suspected that LaFarge had poisoned him and somehow got hold of remnants of food
to which she had supposedly added arsenic. The Marsh test revealed the presence of
arsenic in the food and in a sample of egg nog, but when the victim’s body was
exhumed, the investigating chemist was unable to detect arsenic.
To help prove LaFarge’s innocence by corroborating the results of the investigation of
the exhumed body, the defence enlisted Mathieu Orfila, a chemist acknowledged to be
an authority on the Marsh test. Much to the defence’s chagrin, Orfila showed that the
test had been carried out incorrectly and used the Marsh test to conclusively prove the
presence of arsenic in Mr. LaFarge’s exhumed body. Marie LaFarge was found guilty
and sentenced to life in prison. The controversial case captured the imagination of the
public and was closely followed through newspaper accounts, making LeFarge into a
celebrity. It would also go down in the annals of history as the first case in which a
conviction was secured based on direct forensic toxicological evidence. Because of
Orfila’s role in the case, he is often deemed to be the “founder of the science of
toxicology.” The Marsh test became the subject of everyday conversations and even
became a popular demonstration at fairgrounds and in public lectures. This had an
interesting spinoff. Poisonings by arsenic decreased significantly. The existence of a
reliable test served as a deterrent.
As far as claims about relieving anxiety with homeopathic arsenic go, well, they cause
me anxiety. I think I’ll flush those homeopathic tablets down the drain (no worry about
arsenic pollution here) and buy a colouring book.
xxx.xxxxxxxx@xxxxxx.xx
Joe Schwarcz is director of McGill University’s Office for Science & Society (mcgill.ca/oss). He
hosts The Dr. Joe Show on CJAD Radio 800 AM every Sunday from 3 to 4 p.m.
From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
Date: Tuesday, 10 May 2016 at 10:19
To: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx>, Wolfgang Dekant <xxxxxx@xxxx.xxx-
wuerzburg.de>, Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>, Alan R Boobis
<x.xxxxxx@xxxxxxxx.xx.xx>, Pat Heslop-Harrison <xxxx@xxxxxxxxx.xx.xx>, Helmut Greim
Subject: Re: Brussels expenses
Cheers
Richard
From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
Date: Saturday, 7 May 2016 at 12:27
To: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx>, Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>,
Alan R Boobis <x.xxxxxx@xxxxxxxx.xx.xx>, Pat Heslop-Harrison <xxxx@xxxxxxxxx.xx.xx>, Helmut
Greim
, Wolfgang Dekant <xxxxxx@xxxx.xxx-
wuerzburg.de>
Subject: Re: US Oak Foundation funding on ED
Just a couple of comments/additions, though not sure how helpful they are.
1. I presume the Boston public health grant will have gone to
So not all are as crazy and uncaring of scientific principles as others,
speaking of which…..
2.
So no wonder these folk
feel empowered, they're being given credibility at the highest possible level.
Rant over
Richard
From: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx>
Date: Saturday, 7 May 2016 00:57
To: Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>, Alan R Boobis <x.xxxxxx@xxxxxxxx.xx.xx >, Pat
Heslop-Harrison <xxxx@xxxxxxxxx.xx.xx >, Information Services <x.xxxxxx@xx.xx.xx >, Helmut
Greim
, Wolfgang Dekant <xxxxxx@xxxx.xxx-
wuerzburg.de>
Subject: Fwd: US Oak Foundation funding on ED
Dan
Von meinem iPhone gesendet
Anfang der weitergeleiteten E-Mail:
Von: Datum: 4. Mai 2016 18:14:13 MESZ
An: "xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx" <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx>
Betreff: US Oak Foundation funding on ED
From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
Date: Saturday, 7 May 2016 at 11:49
To: "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx>, Daniel Dietrich <Daniel.Dietrich@uni-
konstanz.de>, Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>, Pat Heslop-Harrison
<xxxx@xxxxxxxxx.xx.xx>, Helmut Greim
, Wolfgang Dekant
<xxxxxx@xxxx.xxxxxxxxxxxxx.xx>
Subject: Re: US Oak Foundation funding on ED
I agree with all of the changes (improvements) made but I think the very last 3 words can now
be deleted as they're redundant.
Best
Richard
From: <Boobis>, Alan R <x.xxxxxx@xxxxxxxx.xx.xx >
Date: Saturday, 7 May 2016 10:11
To: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx >, Information Services
<x.xxxxxx@xx.xx.xx >, Colin Berry
, Pat Heslop-Harrison
<xxxx@xxxxxxxxx.xx.xx >, Helmut Greim
, Wolfgang Dekant
<xxxxxx@xxxx.xxxxxxxxxxxxx.xx >
Subject: RE: US Oak Foundation funding on ED
Dan et al
I think this strikes a reasonable balance between making the point whilst not being overly
confrontational. I have only minor suggestions to this version.
I suspect that there will be time (and need) for a more aggressive piece when the response is
published!
Best wishes,
Alan
From: Daniel Dietrich [mailto:xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx ]
Sent: 07 May 2016 09:11
To: SHARPE Richard <x.xxxxxx@xx.xx.xx >; Colin Berry
; Boobis, Alan
R <x.xxxxxx@xxxxxxxx.xx.xx >; Pat Heslop-Harrison <xxxx@xxxxxxxxx.xx.xx >; Helmut Greim
; Wolfgang Dekant <xxxxxx@xxxx.xxxxxxxxxxxxx.xx >
Subject: Re: US Oak Foundation funding on ED
Importance: High
Dear Richard,
Dan
Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
Professor of Human and Environmental Toxicology,
Faculty of Biology, University of Konstanz
P.O. Box 622
Universitätsstrasse 10
D-78457 Konstanz, Germany
Telephone:
Portable-Phone:
Fax:
email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
http://www.umwelttoxikologie.uni-konstanz.de
Von: SHARPE Richard <x.xxxxxx@xx.xx.xx >
Datum: Samstag, 7. Mai 2016 08:40
An: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx >, Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>,
Alan R Boobis <x.xxxxxx@xxxxxxxx.xx.xx >, Pat Heslop-Harrison <xxxx@xxxxxxxxx.xx.xx >, Helmut
Greim
, Wolfgang Dekant <xxxxxx@xxxx.xxx-
wuerzburg.de>
Betreff: Re: US Oak Foundation funding on ED
OK guys this is how my weekend started!
I've taken the latest version and dis-assembled it and tried to make it clearer why we are making this
statement by explicitly showing what the dark side is proposing and why it is wrong. I'm sure it can be
improved upon, so over to you for this. I turned off track changes when writing this because it was so
difficult to read otherwise but if I know my laptop, the track changes will mysteriously reappear when I
attach the document.
One point: I've tried to really hammer home the clinical endocrinology aspect because (a) this is familiar
to the commissioner, and (b) it ultimately has the biggest public impact because endocrine disorders
are very common (maybe we should mention menopause, the commonest of the lot) and anything that
'doctors' do immediately elevates it to 'fact' status, whether or not that is accurate!
Enjoy your weekend – and I hope I didn't just make it worse.
Richard
From:
SHARPE Richard
To:
NOBLE Ann-Marie
Subject:
FW: EDCs
Date:
17 July 2018 10:12:36
Date: Fri, 6 May 2016 13:27:39 +0100
Subject: Re: EDCs
From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
To: "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx>,
Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx>,
Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>,
"Greim, Helmut"
"Heslop-Harrison, Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx>,
CC: "xxxxxx@xxxx.xxxxxxxxxxxxx.xx" <xxxxxx@xxxx.xxxxxxxxxxxxx.xx>,
I just re-read my e-mail and just wanted to say to Dan that I did not
intend any criticism of him. Getting words down on paper is the most
important first task as then we have a bone to chew upon, so I should have
acknowledged his hard work in taking the first step for us all.
Richard
On 06/05/2016 13:10, "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx> wrote:
>Richard
>
>It certainly resonates with me!
>
>I can sympathise with Dan's concerns following the way in which the
>outcome of the Berlin meeting is being portrayed. But I fully agree with
>you that if we resort to the same tactics we will not achieve anything.
>Our arguments must be evidence-based, level-headed and suitably
>circumspect.
>
>Best wishes,
>
>Alan
>
>-----Original Message-----
>From: SHARPE Richard [mailto:x.xxxxxx@xx.xx.xx
]
>Sent: 06 May 2016 13:04
>To: Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx>; Colin Berry
><xxxxx@xxxxxxxxxxxxx.xx.xx>; Greim, Helmut
>
>; Heslop-Harrison, Pat (Prof.)
><xxxx@xxxxxxxxx.xx.xx>;
>
>Cc: Boobis, Alan R <x.xxxxxx@xxxxxxxx.xx.xx>;
>Subject: Re: EDCs
>
>I¹m not going to get near this today, but based on a quick read through,
>it will need considerable Œtoning down¹. I don¹t think we should be
>making sweeping interpretational statements (e.g. Absolutely no evidence
>that EDCs Š..), as then we are venturing into the same emotional
>territory as occupied by our counterparts. Instead, I think we need to
>give it a measured tone with emphasis solely on the differences between
>hazard and risk and on the critical importance of using evidence rather
>than presumption to guide risk evaluation and regulatory decision-making.
>It also needs to seek an advantage over the other side by pointing out
>that scaremongering and use of emotional arguments should have no place
>in any assessment nor should beliefs - only robust evidence. I also think
>it needs to mention that the goal of protecting the public from harmful
>exposures will never be achieved by basing it on simple
>characterisation/labelling, but only by obtaining sufficiently detailed
>evidence to show how and when a risk may be posed and ten managed
>(including banning a chemical if this is what the evidence supports).
>
>Sorry to just throw this into an e-mial for now, but I thought it might
>help to voice my knee jerk reaction, in case it resonates with anyone
>else.
>
>Best wishes
>
>Richard
>
>On 06/05/2016 11:30, "Daniel Dietrich" <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx>
>wrote:
>
>>Dear
and Dear colleagues.
>>Dan
>>Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
>>
>>Professor of Human and Environmental Toxicology, Faculty of Biology,
>>University of Konstanz P.O. Box 622 Universitätsstrasse 10
>>D-78457 Konstanz, Germany
>>
>>Telephone:
>>Portable-Phone:
>>Fax:
>>email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
>>http://www.umwelttoxikologie.uni-konstanz.de
>>
>>
>>
>>
>>
>>
>>
>>Am 06.05.2016 08:33 schrieb "Colin Berry" unter
>>
>>
>>>Daniel,
>>>I can make sure it goes to Sense about Science and The Science Media
>>>Centre and
at SAS and
will mail it out
>>>to their media contacts if I ask them, I am sure. I am on the Advisory
>>>Boards of both.
>>>Colin
>>>
>>>-----Original Message-----
>>>From: Daniel Dietrich [mailto:xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
]
>>>Sent: Friday, May 6, 2016 7:05 AM
>>>To: Greim, Helmut; Heslop-Harrison, Pat (Prof.)
>>>Cc: Boobis, Alan R; xxxxxx@xxxx.xxxxxxxxxxxxx.xx; x.xxxxxx@xx.xx.xx;
>>>Colin Berry;
>>>Subject: Re: EDCs
>>>
>>>Dan
>>>Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
>>>
>>>Professor of Human and Environmental Toxicology, Faculty of Biology,
>>>University of Konstanz P.O. Box 622 Universitätsstrasse 10
>>>D-78457 Konstanz, Germany
>>>
>>>Telephone:
>>>
>>>Portable-Phone:
>>>Fax:
>>>email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
>>>http://www.umwelttoxikologie.uni-konstanz.de
>>>
>>>
>>>
>>>
>>>
>>>
>>>
>>>Am 05.05.2016 21:13 schrieb "Greim, Helmut" unter
>>><xxxxxx.xxxxx@xxx.xxxxxxxxxxx.xx>:
>>>
>>>>helmut
>>>>
>>>>
>>>>Am 05.05.2016 19:39, schrieb Heslop-Harrison, Pat (Prof.):
>>>>>
>>>>> Pat
>>>>>
>>>>> Professor J.S. (Pat) Heslop-Harrison Department of Genetics
>>>>> University of Leicester Leicester LE1 7RH UK
>>>>>
>>>>> E-mail: xxxx@xx.xx.xx
>>>>>
>>>>> Annals of Botany blog: www.AoBBlog.com [1]
>>>>> Websites: www.molcyt.com [2]
Chief Editor,
>>>>> Annals of Botany: www.annbot.com [3]
>>>>>
>>>>> Phone:
>>>>> Mobile phone:
>>>>> FAX:
>>>>>
>>>>> -------------------------
>>>>>
>>>>> FROM: Boobis, Alan R [x.xxxxxx@xxxxxxxx.xx.xx]
>>>>> SENT: 05 May 2016 18:26
>>>>> TO: Helmut Greim; xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx;
>>>>> xxxxxx@xxxx.xxxxxxxxxxxxx.xx; Heslop-Harrison, Pat (Prof.);
>>>>> x.xxxxxx@xx.xx.xx; xxxxx@xxxxxxxxxxxxx.xx.xx
>>>>> CC:
>>>>> SUBJECT: EDCs
>>>>>
>>>>> Dear all
>>>>>
>>>>> The comments at
>>>>>
>>>>>https://chemicalwatch.com/47135/official-edcs-statement-confirms-pot
>>>>>en
>>>>>cy-
>>>>>not-relevant-for-id
>>>>> [4] emphasize the need for an some commentary to explain the
>>>>>aspects of the statement emphasizing that identification is not the
>>>>>assessment of heath effects in exposed populations.
>>>>>
>>>>> Best wishes,
>>>>>
>>>>> Alan
>>>>>
>>>>>
>>>>> Links:
>>>>> ------
>>>>> [1] http://www.AoBBlog.com
>>>>> [2] http://www.molcyt.com
>>>>> [3] http://www.annbot.com
>>>>> [4]
>>>>>
>>>>>https://chemicalwatch.com/47135/official-edcs-statement-confirms-pot
>>>>>en
>>>>>cy-
>>>>>not-relevant-for-id
>>>
>>>
>>
>
>
>--
>The University of Edinburgh is a charitable body, registered in Scotland,
>with registration number SC005336.
>
From:
SHARPE Richard
To:
NOBLE Ann-Marie
Subject:
FW: Homeopathy
Date:
17 July 2018 10:11:10
Date: Tue, 3 May 2016 17:33:55 +0100
Subject: FW: Homeopathy
From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
To: Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>,
"Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx>,
"Greim, Helmut"
,
"Heslop-Harrison, Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx>
From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
Date: Tuesday, 3 May 2016 at 17:33
To: Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>, "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx>,
"Greim, Helmut"
, "Heslop-Harrison, Pat (Prof.)"
<xxxx@xxxxxxxxx.xx.xx>
Subject: FW: Homeopathy
For your entertainment! http://youtu.be/HMGIbOGu8q0
From: Information Services <x.xxxxxx@xx.xx.xx
>
Date: Monday, 4 April 2016 20:23
To:
Subject: Re: Homeopathy
That is brilliant – captures the absurdity by using humour. Great bit of script writing, especially the
ending.
Cheers from
!
Richard
From:
Reply-To:
Date: Monday, 4 April 2016 13:50
To: Information Services <x.xxxxxx@xx.xx.xx
>,
Subject: Homeopathy
http://youtu.be/HMGIbOGu8q0
Date: Thu, 28 Apr 2016 17:27:09 +0100
Subject: Re: meeting with Commissioner May 3
From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
To: "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx>
CC: "Heslop-Harrison, Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx>,
Daniel Dietrich <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx>,
Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>,
Wolfgang Dekant <xxxxxx@xxxx.xxxxxxxxxxxxx.xx>,
"Greim, Helmut"
,
Thanks Aalan.
OK I'll aim to meet up with you all at midi.
My mobile number is
in case any changes.
Cheers
Richard
On 28/04/2016 15:49, "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx> wrote:
>Richard
>
>We (Colin, Pat and I) are due in at 11:05.
>
>Best wishes,
>
>Alan
>
>Sent from my iPhone
>
>> On 28 Apr 2016, at 14:47, SHARPE Richard <x.xxxxxx@xx.xx.xx> wrote:
>>
>> Meeting up at Midi would be no problem for me, its just 1 more stop down
>> the line. So let me know your arrival time.
>> BW
>>
>> Richard
>>
>>> On 28/04/2016 14:31, "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx> wrote:
>>>
>>> Richard
>>>
>>> The Eurostar gets into Midi station.
>>>
>>> Best wishes,
>>>
>>> Alan
>>>
>>> Sent from my iPhone
>>>
>>>> On 28 Apr 2016, at 14:29, SHARPE Richard <x.xxxxxx@xx.xx.xx> wrote:
>>>>
>>>> Thank you all for your speedy corrections/additions, which have dealt
>>>> with
>>>> everything that I had thought might need changing.
>>>> I think this is about as good and concise as we can aim for whilst
>>>>still
>>>> making the key points in a cogent and cohesive manner.
>>>> It will hopefully provide the basis for the commissioner's questions
>>>>to
>>>> us, which would be a great outcome.
>>>>
>>>> On an organisational point, I'm just wondering about when and how we
>>>> will
>>>> meet up at Berlaymont (I presume at the front entrance). Are those
>>>> arriving by train from UK terminating at Central station? If so, I
>>>>might
>>>> be able to meet up as I arrive early at the airport, and can time my
>>>> trip
>>>> into Central station accordingly.
>>>>
>>>> Best wishes
>>>>
>>>> Richard
>>>>
>>>>> On 28/04/2016 13:00, "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx>
>>>>>wrote:
>>>>>
>>>>> Dear all
>>>>>
>>>>> I have added my suggestions to the version edited by others .
>>>>>
>>>>> Best wishes,
>>>>>
>>>>> Alan
>>>>>
>>>>> ________________________________________
>>>>> From: Heslop-Harrison, Pat (Prof.) <xxxx@xxxxxxxxx.xx.xx>
>>>>> Sent: 28 April 2016 12:03
>>>>> To: 'Daniel Dietrich'; Colin Berry; Wolfgang Dekant; SHARPE Richard;
>>>>> Greim, Helmut
>>>>> Cc: Boobis, Alan R;
>>>>> Subject: RE: meeting with Commissioner May 3
>>>>>
>>>>> Dear All,
>>>>>
>>>>>
>>>>>
>>>>> Pat.
>>>>>
>>>>> Pat Heslop-Harrison
>>>>>
>>>>> Professor J.S. (Pat) Heslop-Harrison
>>>>> Department of Genetics,
>>>>> University of Leicester
>>>>> Leicester LE1 7RH UK
>>>>> xxxx@xx.xx.xx
>>>>> Office:
Mobile:
>>>>> FAX:
>>>>> Web: www.molcyt.com
>>>>> Blog: www.AoBBlog.com
>>>>> Chief Editor, Annals of Botany www.annbot.com
>>>>>
>>>>>
>>>>> -----Original Message-----
>>>>> From: Daniel Dietrich [mailto:xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
]
>>>>> Sent: 28 April 2016 11:28
>>>>> To: Colin Berry; Wolfgang Dekant; SHARPE Richard; Greim, Helmut
>>>>> Cc: Boobis, Alan R; Heslop-Harrison, Pat (Prof.)
>>>>> Subject: Re: meeting with Commissioner May 3
>>>>> Importance: High
>>>>>
>>>>> Dear Wolfgang
>>>>> Dan
>>>>> Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT Professor of Human and
>>>>> Environmental Toxicology, Faculty of Biology, University of Konstanz
>>>>>
>>>>> Universitätsstrasse. 10
>>>>> D-78457 Konstanz, Germany
>>>>>
>>>>> Telephone:
>>>>>
>>>>> Portable-Phone:
>>>>> Fax:
>>>>> email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
>>>>> http://www.umwelttoxikologie.uni-konstanz.de
>>>>>
>>>>>
>>>>>
>>>>>
>>>>>
>>>>>
>>>>>
>>>>> Am 28.04.16 12:16 schrieb "Colin Berry" unter
>>>>>
:
>>>>>
>>>>>> Wolfgang,
>>>>>> I have made changes largely as a "precis" but you may disagree with
>>>>>> "identification" instead of "characterisation" in the first line.
>>>>>> However, I don't think the general rule is to characterise - that
>>>>>> might
>>>>>> be better.
>>>>>> Ignore anything you dislike
>>>>>> Regards
>>>>>> Colin
>>>>>>
>>>>>> -----Original Message-----
>>>>>> From: Wolfgang Dekant [mailto:xxxxxx@xxxx.xxxxxxxxxxxxx.xx
]
>>>>>> Sent: Thursday, April 28, 2016 10:37 AM
>>>>>> To: Daniel Dietrich; Colin Berry; SHARPE Richard; Greim, Helmut
>>>>>> Cc: Boobis, Alan R; xxxx@xxxxxxxxx.xx.xx
>>>>>> Subject: Re: meeting with Commissioner May 3
>>>>>>
>>>>>> Dear all,
>>>>>>
>>>>>> wd
>>>>>>
>>>>>>> Am 27.04.16 um 21:17 schrieb Daniel Dietrich:
>>>>>>> Dear Wolfgang And Richard:
>>>>>>> Dan
>>>>>>>
>>>>>>> Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT
>>>>>>>
>>>>>>> Professor of Human and Environmental Toxicology, Faculty of
>>>>>>>Biology,
>>>>>>> University of Konstanz P.O. Box 622 Universitätsstrasse 10
>>>>>>> D-78457 Konstanz, Germany
>>>>>>>
>>>>>>> Telephone:
>>>>>>>
>>>>>>> Secretary)
>>>>>>> Portable-Phone:
>>>>>>> Fax:
>>>>>>> email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
>>>>>>> http://www.umwelttoxikologie.uni-konstanz.de
>>>>>>>
>>>>>>>
>>>>>>>
>>>>>>>
>>>>>>>
>>>>>>>
>>>>>>>
>>>>>>> Am 27.04.2016 17:03 schrieb "Colin Berry" unter
>>>>>>>
>>>>>>>
>>>>>>>> I think that is super, Richard (and clinical, which will matter)
>>>>>>>> Colin Berry
>>>>>>>>
>>>>>>>> -----Original Message-----
>>>>>>>> From: SHARPE Richard [mailto:x.xxxxxx@xx.xx.xx
]
>>>>>>>> Sent: Wednesday, April 27, 2016 3:59 PM
>>>>>>>> To: Wolfgang Dekant; Greim, Helmut; Colin Berry
>>>>>>>> Cc: Boobis, Alan R; Daniel Dietrich; xxxx@xxxxxxxxx.xx.xx;
>>>>>>>>
>>>>>>>> Subject: Re: meeting with Commissioner May 3
>>>>>>>>
>>>>>>>> Just to add a brief resume that might be included in the 1-page
>>>>>>>> briefing for the commissioner.
>>>>>>>>
>>>>>>>> So-called 'low dose/non-monotonic dose-response curves' for 1 or 2
>>>>>>>> endocrine-disrupting compounds (EDCs) in model systems has been a
>>>>>>>> key
>>>>>>>> argument for adopting a hazard-only based assessment process. It
>>>>>>>>is
>>>>>>>> now widely stated that non-monotonicity is a basic principle of
>>>>>>>> endocrine systems, whereas the opposite is actually the case. The
>>>>>>>> intrinsic homeostatic basis/regulation of all major endocrine
>>>>>>>> systems
>>>>>>>> would not operate if there was non-monotonicity. When this system
>>>>>>>> fails, you do not see the same disease at subnormal (low) and
>>>>>>>> supranormal (high) hormone levels but very different
>>>>>>>> diseases/symptoms with hormone deficiency versus hormone excess
>>>>>>>> (e.g.
>>>>>>>> Addisons v Cushings) that are treated successfully by
>>>>>>>> therapeutically returning hormone levels to normal. The whole of
>>>>>>>> clinical endocrinology is built around this and is based on
>>>>>>>>decades
>>>>>>>> of experience and evidence.
>>>>>>>>
>>>>>>>>
>>>>>>>> Homeostatic regulation may not apply to the hormonal regulation of
>>>>>>>> specific programming/organisational events (e.g. role of androgens
>>>>>>>> in fetal masculinisation) but the evidence we have from animal
>>>>>>>> studies is that only very high doses of EDCs (orders of magnitude
>>>>>>>> higher than human
>>>>>>>>>>> Daniel suggested I forward this, which I sent to him and
>>>>>>>>>>> Helmut earlier.
>>>>>>>>>>> Colin Berry
>>>>>>>>>>>
>>>>>>>>>>> Daniel,
>>>>>>>>>>> I agree about mixtures. The point you make is a
>>>>>>>>>>> difficult one but even if it is thought reasonable to use
>>>>>>>>>>>hazard
>>>>>>>>>>> Identification as a basis for intervention (pace the declared
>>>>>>>>>>> intention of IARC in their pre-amble) there must be data to
>>>>>>>>>>> support any assertion, or almost anything can be used to object
>>>>>>>>>>> to
>>>>>>>>>>> any process involving chemicals (the oxygen, glucose and sodium
>>>>>>>>>>> chloride are all deadly kind of nonsense.)
>>>>>>>>>>> Perhaps something like this should go in what we
>>>>>>>>>>> send.
>>>>>>>>>>>
>>>>>>>>>>> "In identifying any agent which has the potential to do harm,
>>>>>>>>>>> some mechanism of injury should be proposed, some target for
>>>>>>>>>>> disturbance should be identified, some likelihood of
>>>>>>>>>>>significant
>>>>>>>>>>> exposure characterised and some quantitative consideration as
>>>>>>>>>>>to
>>>>>>>>>>> the numbers of those exposed should be made. This will enable
>>>>>>>>>>> the potential benefit of the intervention to be assessed
>>>>>>>>>>>against
>>>>>>>>>>> its potential for harm and will enable the value of a
>>>>>>>>>>> regulatory intervention to be measured."
>>>>>>>>>>>
>>>>>>>>>>> This is very speculative and the result of an on-the-spot
>>>>>>>>>>> thought.
>>>>>>>>>>> Regards
>>>>>>>>>>> Colin
>>>>>>>>>>>
>>>>>>>>>>>
>>>>>>>>>>>
>>>>>>>>>>> -----Original Message-----
>>>>>>>>>>> From: Wolfgang Dekant [mailto:xxxxxx@xxxx.xxxxxxxxxxxxx.xx
]
>>>>>>>>>>> Sent: Tuesday, April 26, 2016 6:55 AM
>>>>>>>>>>> To: Greim, Helmut; Boobis, Alan R
>>>>>>>>>>> Cc: xxxxxx@xxxx.xxxxxxxxxxxxx.xx; SHARPE Richard; Daniel
>>>>>>>>>>> Dietrich; Colin Berry; xxxx@xxxxxxxxx.xx.xx
>>>>>>>>>>> Subject: Re: The Times article
>>>>>>>>>>>
>>>>>>>>>>> Dear all,
>>>>>>>>>>> wd
>>>>>>>>>>>
>>>>>>>>>>>> Am 25.04.16 um 21:10 schrieb Greim, Helmut:
>>>>>>>>>>>> Dear all,
>>>>>>>>>>>> Helmut
>>>>>>>>>>>>
>>>>>>>>>>>> Am 25.04.2016 17:30, schrieb Boobis, Alan R:
>>>>>>>>>>>>> Richard
>>>>>>>>>>>>>
>>>>>>>>>>>>> I agree with these points. We need to consider the
>>>>>>>>>>>>>alternative
>>>>>>>>>>>>> viewpoints and what is it we would like to realistically
>>>>>>>>>>>>> achieve.
>>>>>>>>>>>>>
>>>>>>>>>>>>> In my view we do need to emphasize the importance of risk
>>>>>>>>>>>>> assessment, as opposed to hazard identification for a range
>>>>>>>>>>>>>of
>>>>>>>>>>>>> socio-economic reasons (which we can elaborate); and the
>>>>>>>>>>>>>danger
>>>>>>>>>>>>> of considering risk in isolation, without considering
>>>>>>>>>>>>> alternative risks or benefits.
>>>>>>>>>>>>>
>>>>>>>>>>>>> Best wishes,
>>>>>>>>>>>>>
>>>>>>>>>>>>> Alan
>>>>>>>>>>>>> ________________________________________
>>>>>>>>>>>>> From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
>>>>>>>>>>>>> Sent: 25 April 2016 14:03
>>>>>>>>>>>>> To: Daniel Dietrich; Greim, Helmut; Wolfgang Dekant
>>>>>>>>>>>>> Cc: Colin Berry; Boobis, Alan R; xxxx@xxxxxxxxx.xx.xx
>>>>>>>>>>>>> Subject: Re: The Times article
>>>>>>>>>>>>>
>>>>>>>>>>>>> Dear All
>>>>>>>>>>>>>
>>>>>>>>>>>>> Whilst I agree in principle with what is written in the
>>>>>>>>>>>>> suggested text for the commissioner, I'm not sure that a
>>>>>>>>>>>>> sweeping dismissal of the 'views of the other side' on the
>>>>>>>>>>>>> basis
>>>>>>>>>>>>> of longstanding proven practice is necessarily the most
>>>>>>>>>>>>> convincing approach. It can be seen as failing to move with
>>>>>>>>>>>>>the
>>>>>>>>>>>>> times, sticking ones head in the sand etc etc. We have to
>>>>>>>>>>>>>think
>>>>>>>>>>>>> of what the 'opposition thinkers' would present to the
>>>>>>>>>>>>> commissioner, and whilst we can push some of that away on the
>>>>>>>>>>>>> lack of convincing evidence, it is by no means as certain as
>>>>>>>>>>>>>is
>>>>>>>>>>>>> implied....if we are basing it on available evidence. The
>>>>>>>>>>>>>human
>>>>>>>>>>>>> epidemiological data is, in general, unconvincing but it is
>>>>>>>>>>>>> constrained by all manner of difficulties and whilst many of
>>>>>>>>>>>>> the
>>>>>>>>>>>>> animal experimental studies are not relevant, not well enough
>>>>>>>>>>>>> done or are confounded, based on the evidence I could not
>>>>>>>>>>>>> simply
>>>>>>>>>>>>> sweep it all aside. In particular, the mixtures issue is an
>>>>>>>>>>>>> aspect that I find difficult to dismiss and in general the
>>>>>>>>>>>>> studies on which it is based have been top quality.
>>>>>>>>>>>>> I still don't see that it requires a different set of rules
>>>>>>>>>>>>>for
>>>>>>>>>>>>> its evaluation (i.e. I am not a believer in the 'low dose,
>>>>>>>>>>>>> inverted U' thinking that is increasingly bandied around),
>>>>>>>>>>>>>but
>>>>>>>>>>>>> it unquestionably challenges the current risk assessment
>>>>>>>>>>>>> process.
>>>>>>>>>>>>> There is not a mention of this in the proposed commissioner
>>>>>>>>>>>>> text, which I don't think is wise. To me, the wise approach
>>>>>>>>>>>>>is
>>>>>>>>>>>>> to acknowledge that these new developments need to be
>>>>>>>>>>>>>factored
>>>>>>>>>>>>> into the risk assessment and regulatory process (which will
>>>>>>>>>>>>> take
>>>>>>>>>>>>> some doing), but what would be sheer lunacy is to abandon
>>>>>>>>>>>>>what
>>>>>>>>>>>>> has been proven to work so well up until now. None of us can
>>>>>>>>>>>>> see
>>>>>>>>>>>>> that it will not continue to be the frontline, 'proven in
>>>>>>>>>>>>> practice', optimal way to protect the public, but it has to
>>>>>>>>>>>>> take
>>>>>>>>>>>>> account of the new developments that are evidence-based. So
>>>>>>>>>>>>> there has to be some middle path.
>>>>>>>>>>>>>
>>>>>>>>>>>>> Whilst I'm on my soapbox, I also have never liked the idea of
>>>>>>>>>>>>> using as a defence the argument about 'natural chemicals'
>>>>>>>>>>>>>with
>>>>>>>>>>>>> EDC activity being present in higher amounts than the
>>>>>>>>>>>>> contaminants.
>>>>>>>>>>>>> Its a weak defence that is easily attacked from several
>>>>>>>>>>>>>angles.
>>>>>>>>>>>>> Far better to rely on the proven principles of toxicology
>>>>>>>>>>>>>etc.
>>>>>>>>>>>>>
>>>>>>>>>>>>> I offer these gut reactions of mine as fuel for our thoughts
>>>>>>>>>>>>> and discussions and will be happy to have them shot down in
>>>>>>>>>>>>> flames!
>>>>>>>>>>>>>
>>>>>>>>>>>>> All the best
>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>> Dan
>>>>>>>>>>>>>>>>> Prof. Dr. Daniel Dietrich, Ph.D., FATS, ERT Professor of
>>>>>>>>>>>>>>>>> Human and Environmental Toxicology, Faculty of Biology,
>>>>>>>>>>>>>>>>> University of Konstanz
>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>> Universitätsstrasse. 10
>>>>>>>>>>>>>>>>> D-78457 Konstanz, Germany
>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>> Telephone:
>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>> Portable-Phone:
>>>>>>>>>>>>>>>>> Fax:
>>>>>>>>>>>>>>>>> email: xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx
>>>>>>>>>>>>>>>>> http://www.umwelttoxikologie.uni-konstanz.de
>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>> Am 25.04.16 10:42 schrieb "Greim, Helmut" unter
>>>>>>>>>>>>>>>>> <xxxxxx.xxxxx@xxx.xxxxxxxxxxx.xx>:
>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>>> Helmut
>>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>>> Am 24.04.2016 17:44, schrieb Colin Berry:
>>>>>>>>>>>>>>>>>>> Do we send them papers in advance? This from Matt
>>>>>>>>>>>>>>>>>>>Ridley
>>>>>>>>>>>>>>>>>>> is good and my comments about hazard based systems and
>>>>>>>>>>>>>>>>>>> reproducibility was focussed on IARC - do we send this
>>>>>>>>>>>>>>>>>>> kind of thing?
>>>>>>>>>>>>>>>>>>> Regards to all
>>>>>>>>>>>>>>>>>>> Colin
>>>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>>>> -----Original Message-----
>>>>>>>>>>>>>>>>>>> From: Boobis, Alan R [mailto:x.xxxxxx@xxxxxxxx.xx.xx
]
>>>>>>>>>>>>>>>>>>> Sent: Sunday, April 24, 2016 3:05 PM
>>>>>>>>>>>>>>>>>>> To: Greim, Helmut; xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx;
>>>>>>>>>>>>>>>>>>> xxxxxx@xxxx.xxxxxxxxxxxxx.xx; xxxx@xxxxxxxxx.xx.xx;
>>>>>>>>>>>>>>>>>>> x.xxxxxx@xx.xx.xx; Colin Berry
>>>>>>>>>>>>>>>>>>> Subject: Re: The Times article
>>>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>>>> Helmut
>>>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>>>> I though this was a very helpful article in that it
>>>>>>>>>>>>>>>>>>> identified many of the issues that concern us and would
>>>>>>>>>>>>>>>>>>> be well worth discussing with the commissioner.
>>>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>>>> Best wishes,
>>>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>>>> A;an
>>>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>>>> ________________________________________
>>>>>>>>>>>>>>>>>>> From: Greim, Helmut <xxxxxx.xxxxx@xxx.xxxxxxxxxxx.xx>
>>>>>>>>>>>>>>>>>>> Sent: 24 April 2016 14:58
>>>>>>>>>>>>>>>>>>> To: Boobis, Alan R; xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx;
>>>>>>>>>>>>>>>>>>> xxxxxx@xxxx.xxxxxxxxxxxxx.xx; xxxx@xxxxxxxxx.xx.xx;
>>>>>>>>>>>>>>>>>>> x.xxxxxx@xx.xx.xx;
>>>>>>>>>>>>>>>>>>> Subject: The Times article
>>>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>>>> Dear all,
>>>>>>>>>>>>>>>>>>> Best Helmut
>>>>>>>>>>>>>>>>>>>
>>>>>>>>>>>>>>>>>>> Stop misusing science to scare the world By Matt Ridley
>>>>>>>>>>>>>>>>>>> De Niro's intervention in the MMR vaccine row
>>>>>>>>>>>>>>>>>>>highlights
>>>>>>>>>>>>>>>>>>> how the cherry-picking of data is warping our
>>>>>>>>>>>>>>>>>>> understanding Science, humanity's greatest
>>>>>>>>>>>>>>>>>>>intellectual
>>>>>>>>>>>>>>>>>>> achievement, has always been vulnerable to infection
>>>>>>>>>>>>>>>>>>>by
>>>>>>>>>>>>>>>>>>> pseudoscience, which pretends to use the methods of
>>>>>>>>>>>>>>>>>>> science, but actually subverts them in pursuit of an
>>>>>>>>>>>>>>>>>>> obsession. Instead of evidence-based policymaking,
>>>>>>>>>>>>>>>>>>> pseudoscience specialises in policy-based evidence
>>>>>>>>>>>>>>>>>>> making.
>>>>>>>>>>>>>>>>>>> Today, this infection is spreading.
>>>>>>>>>>>>>>>>>>> Two egregious examples show just how easy it is to
>>>>>>>>>>>>>>>>>>> subvert the scientific process. The campaign by Andrew
>>>>>>>>>>>>>>>>>>> Wakefield against the MMR vaccine, recently boosted by
>>>>>>>>>>>>>>>>>>> Robert De Niro's support, is pseudoscience.
>>>>>>>>>>>>>>>>>>> So is the campaign against glyphosate ("Roundup")
>>>>>>>>>>>>>>>>>>> weedkiller, which has now resulted in the European
>>>>>>>>>>>>>>>>>>> parliament recommending a ban on its use by gardeners.
>>>>>>>>>>>>>>>>>>> A large dossier claiming to find evidence that
>>>>>>>>>>>>>>>>>>>glyphosate
>>>>>>>>>>>>>>>>>>> is "probably carcinogenic" was published last year by
>>>>>>>>>>>>>>>>>>>the
>>>>>>>>>>>>>>>>>>> International Agency for Research on Cancer (IARC),
>>>>>>>>>>>>>>>>>>>part
>>>>>>>>>>>>>>>>>>> of the World Health Organisation.
>>>>>>>>>>>>>>>>>>> What
>>>>>>>>>>>>>>>>>>> could be more scientifically respectable?
>>>>>>>>>>>>>>>>>>> Yet the document depends heavily on the work of an
>>>>>>>>>>>>>>>>>>> activist employed by a pressure group called the
>>>>>>>>>>>>>>>>>>> Environmental Defense
>>>>>>>>>>>>>>>>>>> Fund:
>>>>>>>>>>>>>>>>>>> Christopher
>>>>>>>>>>>>>>>>>>> Portier, whose conflict of interest the IARC twice
>>>>>>>>>>>>>>>>>>> omitted to disclose.
>>>>>>>>>>>>>>>>>>> Portier chaired the committee that proposed a study on
>>>>>>>>>>>>>>>>>>> glyphosate and then served as technical adviser to the
>>>>>>>>>>>>>>>>>>> IARC's glyphosate report team, even though he is not a
>>>>>>>>>>>>>>>>>>> toxicologist.
>>>>>>>>>>>>>>>>>>> He has since been campaigning against glyphosate.
>>>>>>>>>>>>>>>>>>> The IARC study is surely pseudoscience. It relies on a
>>>>>>>>>>>>>>>>>>> tiny number of cherry-picked studies, and even these
>>>>>>>>>>>>>>>>>>> don't
>>>>>>>>>>>>>>>>>>> support its conclusion.
>>>>>>>>>>>>>>>>>>> The evidence that it causes cancer in humans is
>>>>>>>>>>>>>>>>>>> especially tenuous, based on three epidemiological
>>>>>>>>>>>>>>>>>>> studies with confounding factors and small sample
>>>>>>>>>>>>>>>>>>>sizes
>>>>>>>>>>>>>>>>>>> "linking" it to Non-Hodgkin lymphoma (NHL). The study
>>>>>>>>>>>>>>>>>>> ignored the US Agricultural Health Study, which has
>>>>>>>>>>>>>>>>>>>been
>>>>>>>>>>>>>>>>>>> tracking some
>>>>>>>>>>>>>>>>>>> 89,000 farmers and their spouses for 23 years.
>>>>>>>>>>>>>>>>>>> The study found "no association between glyphosate
>>>>>>>>>>>>>>>>>>> exposure and all cancer incidence or most of the
>>>>>>>>>>>>>>>>>>>specific
>>>>>>>>>>>>>>>>>>> cancer subtypes we evaluated, including NHL . . ."
>>>>>>>>>>>>>>>>>>> Many other studies found very little cancer risk from
>>>>>>>>>>>>>>>>>>> glyphosate use, but the IARC argued that they included
>>>>>>>>>>>>>>>>>>> some data generated by industry.
>>>>>>>>>>>>>>>>>>> Well, of course they did, because we rightly demand
>>>>>>>>>>>>>>>>>>>that
>>>>>>>>>>>>>>>>>>> industry, not the taxpayer, pays for and does the
>>>>>>>>>>>>>>>>>>>safety
>>>>>>>>>>>>>>>>>>> testing of its products and makes the results public.
>>>>>>>>>>>>>>>>>>>The
>>>>>>>>>>>>>>>>>>> IARC appeared to ignore work by the German Federal
>>>>>>>>>>>>>>>>>>> Institute for Risk Assessment, managing the glyphosate
>>>>>>>>>>>>>>>>>>> dossier for the European Commission, which judged
>>>>>>>>>>>>>>>>>>> glyphosate safe.
>>>>>>>>>>>>>>>>>>> As
>>>>>>>>>>>>>>>>>>> did the European Food Safety Authority, whose head
>>>>>>>>>>>>>>>>>>> accused the IARC and Portier of bringing in the
>>>>>>>>>>>>>>>>>>> "Facebook
>>>>>>>>>>>>>>>>>>> age of science".
>>>>>>>>>>>>>>>>>>> When Portier's role and the IARC's findings were
>>>>>>>>>>>>>>>>>>>revealed
>>>>>>>>>>>>>>>>>>> by David Zaruk, who blogs under the name the
>>>>>>>>>>>>>>>>>>>Risk-Monger,
>>>>>>>>>>>>>>>>>>> pressure started coming from many groups to censor his
>>>>>>>>>>>>>>>>>>> science-policy blog.
>>>>>>>>>>>>>>>>>>> The publisher EurActiv was forced to shut down Zaruk's
>>>>>>>>>>>>>>>>>>> entire blog in the week of the European parliament
>>>>>>>>>>>>>>>>>>>vote.
>>>>>>>>>>>>>>>>>>> This is how Big Green behaves in Brussels, routinely.
>>>>>>>>>>>>>>>>>>> Dose for dose, glyphosate is half as toxic as vinegar,
>>>>>>>>>>>>>>>>>>> and one tenth as carcinogenic as caffeine. Not that
>>>>>>>>>>>>>>>>>>> coffee's dangerous
>>>>>>>>>>>>>>>>>>> - but the chemicals in it, like those in virtually any
>>>>>>>>>>>>>>>>>>> vegetable, are dangerous in lab tests at absurdly high
>>>>>>>>>>>>>>>>>>> concentrations. So is dihydrogen monoxide, for that
>>>>>>>>>>>>>>>>>>> matter, if you inhale it, drink it to excess or let its
>>>>>>>>>>>>>>>>>>> gaseous form burn your skin (that's H2O, by the way).
>>>>>>>>>>>>>>>>>>> Besides, risk is hazard plus exposure, a point ignored
>>>>>>>>>>>>>>>>>>>by
>>>>>>>>>>>>>>>>>>> the IARC.
>>>>>>>>>>>>>>>>>>> If
>>>>>>>>>>>>>>>>>>> you routinely put coffee down your throat, you are
>>>>>>>>>>>>>>>>>>> exposing yourself to the infinitesimal hazard caffeine
>>>>>>>>>>>>>>>>>>> represents. If you spray a little Roundup on your
>>>>>>>>>>>>>>>>>>>garden
>>>>>>>>>>>>>>>>>>> path, you are not even exposing yourself to the more
>>>>>>>>>>>>>>>>>>> infinitesimal hazard of glyphosate.
>>>>>>>>>>>>>>>>>>> Roundup is probably the safest herbicide ever, with no
>>>>>>>>>>>>>>>>>>> persistence in the environment. But the Green Blob
>>>>>>>>>>>>>>>>>>>hates
>>>>>>>>>>>>>>>>>>> it for three reasons.
>>>>>>>>>>>>>>>>>>> It's
>>>>>>>>>>>>>>>>>>> off-patent and therefore cheap. It was invented by
>>>>>>>>>>>>>>>>>>> Monsanto, a company that had the temerity to make a
>>>>>>>>>>>>>>>>>>> contribution to reducing famine and lowering food
>>>>>>>>>>>>>>>>>>>prices
>>>>>>>>>>>>>>>>>>> through innovation in agriculture. And some genetically
>>>>>>>>>>>>>>>>>>> modified crops have been made resistant to it, so that
>>>>>>>>>>>>>>>>>>> they can be weeded after planting by spraying, rather
>>>>>>>>>>>>>>>>>>> than
>>>>>>>>>>>>>>>>>>> tilling the
>>>>>>>>>>>>>>>>>>> ground: this no-till farming is demonstrably better for
>>>>>>>>>>>>>>>>>>> the environment, by the way.
>>>>>>>>>>>>>>>>>>> Under the influence, at least in part of the IARC
>>>>>>>>>>>>>>>>>>>report,
>>>>>>>>>>>>>>>>>>> the European parliament voted last week to advise the
>>>>>>>>>>>>>>>>>>> commission to ban glyphosate immediately for
>>>>>>>>>>>>>>>>>>> "non-professionals" - ie gardeners - but allow it for
>>>>>>>>>>>>>>>>>>> seven years for farmers. However, a lie is halfway
>>>>>>>>>>>>>>>>>>>round
>>>>>>>>>>>>>>>>>>> the world before the truth has got its boots on:
>>>>>>>>>>>>>>>>>>>already
>>>>>>>>>>>>>>>>>>> retailers worldwide are dropping glyphosate, Waitrose
>>>>>>>>>>>>>>>>>>> included.
>>>>>>>>>>>>>>>>>>> Much the same happened with the ban on neonicotinoid
>>>>>>>>>>>>>>>>>>> pesticides, which was pushed through Brussels by a
>>>>>>>>>>>>>>>>>>> tsunami
>>>>>>>>>>>>>>>>>>> of angry emails from greens, in the teeth of clear
>>>>>>>>>>>>>>>>>>> scientific advice that honey bee numbers were
>>>>>>>>>>>>>>>>>>>increasing
>>>>>>>>>>>>>>>>>>> and that alternative insecticides were worse.
>>>>>>>>>>>>>>>>>>> James Gurney, a microbiologist who blogs on a site
>>>>>>>>>>>>>>>>>>>called
>>>>>>>>>>>>>>>>>>> the League of Nerds, describes the level of scholarship
>>>>>>>>>>>>>>>>>>> in
>>>>>>>>>>>>>>>>>>> the IARC report as "on a par with Andrew Wakefield of
>>>>>>>>>>>>>>>>>>> MMR/autism fame".
>>>>>>>>>>>>>>>>>>> In the case of Mr Wakefield's claim that the measles,
>>>>>>>>>>>>>>>>>>> mumps and rubella
>>>>>>>>>>>>>>>>>>> (MMR) vaccine causes autism, the push-back against
>>>>>>>>>>>>>>>>>>> pseudoscience largely succeeded in this country, though
>>>>>>>>>>>>>>>>>>> not before real harm had been done.
>>>>>>>>>>>>>>>>>>> Journalists found that Mr Wakefield had failed to
>>>>>>>>>>>>>>>>>>>declare
>>>>>>>>>>>>>>>>>>> financing from lawyers preparing to sue vaccine makers
>>>>>>>>>>>>>>>>>>> and
>>>>>>>>>>>>>>>>>>> had taken blood samples at his own children's party;
>>>>>>>>>>>>>>>>>>> further research failed to replicate his results. His
>>>>>>>>>>>>>>>>>>> paper was retracted and he was struck off the medical
>>>>>>>>>>>>>>>>>>> register, the General Medical Council calling him
>>>>>>>>>>>>>>>>>>> dishonest and irresponsible. His message is now
>>>>>>>>>>>>>>>>>>>falling
>>>>>>>>>>>>>>>>>>> on
>>>>>>>>>>>>>>>>>>> fertile ground in the United States, however, where
>>>>>>>>>>>>>>>>>>> measles epidemics have resumed as a result.
>>>>>>>>>>>>>>>>>>> In both these cases, superficial plausibility is lent
>>>>>>>>>>>>>>>>>>>to
>>>>>>>>>>>>>>>>>>> the scares by history. Earlier pesticides were more
>>>>>>>>>>>>>>>>>>> dangerous:
>>>>>>>>>>>>>>>>>>> copper sulphate (still used as a fungicide by "organic"
>>>>>>>>>>>>>>>>>>> farmers) is toxic; DDT insecticide did wipe out
>>>>>>>>>>>>>>>>>>>predatory
>>>>>>>>>>>>>>>>>>> birds; paraquat herbicide was used in suicides. But
>>>>>>>>>>>>>>>>>>> Roundup is far, far less dangerous than these.
>>>>>>>>>>>>>>>>>>> Likewise, early vaccines did carry risks. In the 1950s
>>>>>>>>>>>>>>>>>>> polio vaccines, grown in monkey tissue, were
>>>>>>>>>>>>>>>>>>>contaminated
>>>>>>>>>>>>>>>>>>> with SV40, a virus associated with cancer in monkeys.
>>>>>>>>>>>>>>>>>>> Many
>>>>>>>>>>>>>>>>>>> children were infected with the virus as a result.
>>>>>>>>>>>>>>>>>>> Fortunately, SV40 proved neither infectious nor
>>>>>>>>>>>>>>>>>>> carcinogenic in human beings, but it was a bullet
>>>>>>>>>>>>>>>>>>>dodged.
>>>>>>>>>>>>>>>>>>> Today such contamination is impossible.
>>>>>>>>>>>>>>>>>>> Pseudoscience is bad enough when it infects
>>>>>>>>>>>>>>>>>>>astrologers,
>>>>>>>>>>>>>>>>>>> 9/11 truthers and crop-circle makers. But when its
>>>>>>>>>>>>>>>>>>> symptoms show up in mainstream bodies, such as the
>>>>>>>>>>>>>>>>>>>World
>>>>>>>>>>>>>>>>>>> Health Organisation, it's time to be worried.
>>>>>>>>>>> --
>>>>>>>>>>> Prof. Dr. Wolfgang Dekant
>>>>>>>>>>> Department of Toxicology
>>>>>>>>>>> University of Wuerzburg
>>>>>>>>>>> Versbacher Str. 9
>>>>>>>>>>> 97078 Wuerzburg
>>>>>>>>>>> Tel.:
>>>>>>>>>>> Fax:
>>>>>>>>> --
>>>>>>>>> Prof. Dr. Wolfgang Dekant
>>>>>>>>> Department of Toxicology
>>>>>>>>> University of Wuerzburg
>>>>>>>>> Versbacher Str. 9
>>>>>>>>> 97078 Wuerzburg
>>>>>>>>> Tel.:
>>>>>>>>> Fax:
>>>>>>
>>>>>> --
>>>>>> Prof. Dr. Wolfgang Dekant
>>>>>> Department of Toxicology, University of Wuerzburg Versbacher Str. 9,
>>>>>> 97078 Wuerzburg, Germany Tel.
>>>>>> Fax:
>>>>>> Mobil:
>>>>
>>>> The University of Edinburgh is a charitable body, registered in
>>>> Scotland, with registration number SC005336.
>>
>> The University of Edinburgh is a charitable body, registered in
>> Scotland, with registration number SC005336.
>>>
>>> wd
>>>
>>> Am 25.04.16 um 21:10 schrieb Greim, Helmut:
>>>> Dear all,
>>>> Helmut
>>>>
>>>> Am 25.04.2016 17:30, schrieb Boobis, Alan R:
>>>>> Richard
>>>>>
>>>>> I agree with these points. We need to consider the alternative
>>>>> viewpoints and what is it we would like to realistically achieve.
>>>>>
>>>>> In my view we do need to emphasize the importance of risk
>>>>> assessment,
>>>>> as opposed to hazard identification for a range of socio-economic
>>>>> reasons (which we can elaborate); and the danger of considering risk
>>>>> in isolation, without considering alternative risks or benefits.
>>>>>
>>>>> Best wishes,
>>>>>
>>>>> Alan
>>>>> ________________________________________
>>>>>
Environ Health Perspect DOI: 10.1289/EHP217
Advance Publication: Not Copyedited
Scientific Issues Relevant to Setting Regulatory Criteria to
Identify Endocrine Disrupting Substances in the European Union
Rémy Slama1, Jean-Pierre Bourguignon2, Barbara Demeneix3, Richard Ivell4, Giancarlo
Panzica5, Andreas Kortenkamp6, and Thomas Zoeller7
1Inserm and Univ. Grenoble Alpes, IAB joint research center, Team of Environmental
Epidemiology, Grenoble, France; 2Pediatric Endocrinology, CHU Liège and
Neuroendocrinology Unit, GIGA Neurosciences, Univ. Liège, Belgium; 3UMR
CNRS/MNHN 7221, Dept. RDDM, Muséum National d'Histoire Naturelle, 75005 Paris,
France; 4School of Biosciences & School of Veterinary Medicine and Science, University of
Nottingham, UK; 5Dept. Neuroscience, University of Torino, and Neuroscience Institute
Cavalieri Ottolenghi (NICO), Orbassano, Italy; 6Brunel University London, Institute of
Environment, Health and Societies, Uxbridge, UK; 7University of Massachusetts, Biology
Department, Amherst, Massachusetts, USA
Address correspondence to Rémy Slama, E-mail: xxxx.xxxxx@xxxxxxxxxxxx.xx
Running title: Criteria to identify endocrine disruptors
Acknowledgments: The authors acknowledge the support of the Endocrine Society for
meetings related to endocrine disruptors.
Competing financial interests: None. Additional information: RS, JPB, BD, RI, GP and TZ
have had travel fees covered by the Endocrine Society (non-profit organization) for travel and
accommodation expenses to meetings related to endocrine disruptors.
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Environ Health Perspect DOI: 10.1289/EHP217
Advance Publication: Not Copyedited
ABSTRACT
Background: Endocrine Disruptors (EDs) are defined by WHO as exogenous compounds or
mixtures that alter function(s) of the endocrine system and consequently cause adverse effects
in an intact organism, or its progeny, or (sub)populations. European regulations on pesticides,
biocides, cosmetics, and industrial chemicals require the European Commission to establish
scientific criteria to define EDs.
Objectives: We address the scientific relevance of four options for the identification of EDs
proposed by the European Commission.
Discussion: Option 1, which does not define EDs and implies to use interim criteria unrelated
to the WHO definition of EDs, is not relevant. Options 2 and 3 rely on the WHO definition for
EDs, which is widely accepted by the scientific community, with option 3 introducing
additional categories based on the strength of evidence (suspected EDs and endocrine active
substances). Option 4 adds potency to the WHO definition, as a decision criterion. We argue
that potency is dependent on the adverse effect considered, is scientifically ambiguous and
note that potency is not used as a criterion to define other particularly hazardous substances
such as carcinogens and reproductive toxicants. The use of potency requires a context that
goes beyond hazard identification and corresponds to risk characterization, in which potency
(or, more relevantly, the dose-response function) is combined with exposure levels.
Conclusions: There is scientific agreement regarding the adequacy of the WHO definition of
EDs. The potency concept is not relevant to the identification of particularly serious hazards
such as EDs. As is common practice for carcinogens, mutagens and reproductive toxicants, a
multi-level classification of ED based on the WHO definition, and not considering potency,
would be relevant (corresponding to option 3 proposed by the European Commission).
2
Environ Health Perspect DOI: 10.1289/EHP217
Advance Publication: Not Copyedited
Introduction
The regulation of chemicals identifies specific classes of health hazards such as carcinogens,
mutagens and reprotoxicants. Endocrine disruptors (EDs) are a new type of hazard identified
by research. WHO defined an ED as “…an exogenous substance or mixture that alters the
function(s) of the endocrine system and consequently causes adverse effects in an intact
organism, or its progeny, or (sub)populations” (WHO/IPCS 2002). Following the first
scientific reference to EDs (Colborn et al. 1993), a large body of research has considerably
improved our understanding of their effects in wildlife and humans (e.g., Braun et al. 2011;
Delfosse et al. 2014; Frye et al. 2012; Heindel et al. 2015; Kortenkamp et al. 2011; Shelton et
al. 2014; UNEP/WHO 2013; Warner et al. 2014; Woodruff et al. 2011).
In 1999, the European Union (EU) became the first major economy to develop a strategy for
the regulation of EDs (European Commission 1999). Subsequently, EDs have been addressed
in at least four acts of EU law: the water framework directive (European Parliament 2000),
REACH (the European Regulation on Registration, Evaluation, Authorisation and Restriction
of Chemicals)(European Parliament 2006), the Cosmetics Regulation (European Parliament
2009a), the Plant Protection Products Regulation (PPPR)(European Parliament 2009b), as
well as the Biocidal Products Regulation (European Parliament 2012). The two latter
regulations required the European Commission to establish scientific criteria to identify
substances with endocrine disrupting properties before December 2013.
The PPPR and the BPR specify that substances with ED properties used as pesticides or
biocides will not receive approval for their use, with certain exceptions (e.g., if exposure is
negligible). Thus, these laws are not based on risk assessment for EDs present in biocides and
pesticides, but only require hazard identification if exposure is not negligible. This
corresponds to so-called "hazard-based cut-off criteria" (see Figure 1 for the distinction
3
Environ Health Perspect DOI: 10.1289/EHP217
Advance Publication: Not Copyedited
between hazard – a source of potential health effects – and risk – the actual impact of a
substance in a population, in terms of disease probability or number of attributable disease
cases). This hazard-based approach to pesticide and biocide regulation has been opposed by
companies that market pesticides and biocides (CEFIC 2013; European commission 2015;
European Crop Protection Association 2014).
In addition, editors of pharmacology and toxicology journals condemned in an editorial the
proposed European Commission recommendations on ED regulations, which they claimed
were based on scientifically unfounded precaution, defied common sense and well-established
risk assessment principles; they called for the consideration of adverse effects and potency
(Dietrich et al. 2013). Their editorial was criticized for being based on a factually incorrect
interpretation of the proposed regulatory framework and for ignoring the programming role of
the endocrine system during development (Bergman et al. 2013, Gore et al. 2013). Its authors
were also called upon to provide information about potential conflicts of interest (Grandjean
and Ozonoff 2013).
At a meeting convened by the EU Commission including signatories of the Dietrich et al.
editorial and scientists with a strong base in ED research, a consensus was reached on the
definition of EDs, on the existence of non-monotonic dose-responses and on the difficulties of
determining thresholds for EDs (European commission 2013).
Despite the obligations to establish scientific criteria to identify EDs by December 2013, as
specified by EU laws (European Parliament 2009b, 2012), no such criteria were published to
date by the European Commission. Instead, the European Commission published a roadmap
listing four options for defining criteria for identifying EDs and initiated an assessment of
their impact (European Commission 2014)(Table 1). One of the options included in the
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Environ Health Perspect DOI: 10.1289/EHP217
Advance Publication: Not Copyedited
roadmap (option 4) would use potency as a decision criterion during the process of hazard
identification.
The disregard for the obligations laid down in EU law led Sweden and several other EU
countries to sue the European Commission. In December 2015, the European Court of Justice
ruled that the European Commission acted unlawfully in failing to develop ED criteria and
that an impact assessment was unnecessary (European Court of Justice 2015). This judgment
heightened the urgency of developing scientifically-based regulatory criteria for identifying
EDs.
Objectives
We elaborate some principles of ED regulation and specifically discuss the scientific
relevance of each option considered by the European Commission to identify an ED,
reviewing the availability of accepted definitions of EDs, endocrine active substances, and the
relevance of the concept of potency for hazard identification. A parallel with carcinogens is
drawn. The relevance of impact assessment studies to define scientific criteria is finally
discussed.
Discussion
I. Proposed options regarding criteria for EDs in Europe
The general intention of defining ED criteria is “to ensure a high level of protection to human
health and the environment and to strengthen the functioning of the internal market”
(European Commission 2014). The four options proposed (European Commission 2014) are
detailed in Table 1 and summarized below:
-
Option 1 consists of no policy change and no specification of criteria;
-
Option 2 relies on the World Health Organization (WHO) definition to identify EDs
(WHO/IPCS 2002). This option a) identifies EDs as substances known or presumed to
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Advance Publication: Not Copyedited
cause endocrine-mediated adverse effects in humans or animal species living in the
environment; b) stipulates that endocrine-mediated adverse effects should not be a
non-specific secondary consequence of other toxic effects; c) defines
adverse effects
(as discussed below); d) excludes substances for which there is information
demonstrating that the effects are not relevant for humans and for animal species
living in the environment; and finally e) lists the step-by-step procedure to be followed
for the identification;
-
Option 3 relies on the identification of ED as in Option 2 and further defines
suspected
endocrine disruptors and
endocrine active substances (see below);
-
Option 4 relies on the WHO/IPCS definition of ED, and includes
potency as element
of hazard characterization. Potency is not defined, nor is the manner in which it would
be combined with the ED definition.
The European Commission (2014) indicated that Option 1 (
no specification of criteria) would
run counter to the requirements of regulations calling for an operational definition of EDs.
Moreover, the PPPR and BPR laws mention
interim criteria, and these would likely apply.
According to these interim criteria, all substances classified as carcinogenic category 2 or
toxic for reproduction category 2 shall be considered as EDs (European Parliament 2009b).
These interim criteria based on the definitions of carcinogens and reproductive toxicants have
no scientific relevance to the WHO/IPCS definition of endocrine disruptors (WHO/IPCS
2002), so that Option 1 would not be scientifically justified. Consequently, we do not discuss
this option further.
II. Availability of a definition of EDs
Option 2 of the roadmap defines EDs and
adverse effect.
At a workshop convened in 1996 in
Weybridge (UK) by the European Commission, WHO and other institutions, an ED was
defined as "an exogenous substance that causes adverse health effects in an intact organism,
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Environ Health Perspect DOI: 10.1289/EHP217
Advance Publication: Not Copyedited
or its progeny, secondary to changes in endocrine function" (quoted by EFSA Scientific
Committee 2013). Several definitions were subsequently suggested by Canadian, Japanese
and other institutions (reviewed by Kortenkamp et al. 2011), after which the International
Program on Chemical Safety (IPCS), in collaboration with experts from Canada, Japan, the
USA, and the EU, defined an ED as “…an exogenous substance or mixture that alters the
function(s) of the endocrine system and consequently causes adverse effects in an intact
organism, or its progeny, or (sub)populations” (WHO/IPCS 2002). The main differences with
the Weybridge definition are the consideration of mixtures and of effects in populations or
subpopulations.
The definition issued from the workshop convened by the US-Environmental Protection
Agency (EPA) in 1995 in Raleigh (Kavlock et al. 1996), which is still referred to by EPA
(EPA 2015), differs from the WHO/IPCS definition by lack of reference to adverse effects. As
discussed below, substances acting on the endocrine system without evidence of an adverse
health effect would be defined as endocrine active substances under Option 3.
It can be noted that for other categories of health hazards, specific adverse health effects are
often referred to, as is the case for carcinogens or reprotoxins, while for mutagens there is
only a reference to a mode of action. The WHO/IPCS definition of EDs refers to both a mode
of action and an adverse effect at the scale of organs, organisms or populations. Consequently,
conclusions about the nature of an ED require the integration of biochemical, toxicological,
ecotoxicological/human data.
EFSA recommended that the WHO/IPCS definition be "adopted as a basis for the criteria for
the identification of EDs" (EFSA Scientific Committee 2013). The European Commission
roadmap acknowledges that "there is general consensus on the WHO/IPCS (2002) definition
of an ED" (European Commission 2014).
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The ED definition mentions
adverse effects. Adverse effects were defined as a "change in the
morphology, physiology, growth, development, reproduction or lifespan of an organism,
system or (sub)population that results in an impairment of functional capacity, an impairment
of the capacity to compensate for additional stress or an increase in susceptibility to other
influences" (WHO/IPCS 2009). The EC roadmap explicitly refers to this definition. This
definition covers health effects at the individual level such as occurrence of diabetes or
obesity, IQ loss, as well as congenital malformations, or changes not visible at the individual
but only at the population level, such as alteration of the sex-ratio. It excludes, among others,
transient changes in hormone levels that would not induce health effects in the short or long
term. To our knowledge this definition has not been questioned. The expression of
“(sub)population” in WHO/IPCS definition refers to effects that may concern the population
as a whole or a specific subgroup (e.g. based on gender, age, genetic susceptibility, etc.).
III Suspected EDs and Endocrine Active Substances (Option 3)
In addition to defining an ED as in Option 2, Option 3 proposes two additional categories,
suspected endocrine disruptors and endocrine active substances
(EAS), that express the
strength of evidence for a given compound
.
Suspected endocrine disruptors are defined in the roadmap as “Substances where there is
some evidence for endocrine-mediated adverse effects from humans, animal species living in
the environment or from experimental studies, but where the evidence is not sufficiently
strong to place the substance in Category I…” (European Commission 2014). This definition
is close to the WHO/IPCS definition of a
possible endocrine disruptor (“an exogenous
substance or mixture that possesses properties that might be expected to lead to endocrine
disruption in an intact organism, or its progeny, or (sub)populations.") (WHO/IPCS 2002).
Endocrine active substances are defined in the European Commission roadmap as:
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“Substances for which there is some (…) potential for endocrine disruption mediated adverse
effects in intact organisms and where the evidence is not sufficiently convincing to place the
substance in category I [ED] or II [suspected ED]" (European Commission 2014). We believe
that the terminology of
endocrine active substance does not convey this lower level of
evidence (a hierarchy such as ED [category I], presumed ED and suspected ED, similar to that
of carcinogens shown in Table 1, would better fit this purpose). In contrast, an
Endocrine
active substance is defined by EFSA as “any chemical that can interact directly or indirectly
with the endocrine system, and subsequently result in an effect on the endocrine system, target
organs and tissues” (EFSA Scientific Committee 2013). The term is used to cover “all
substances that in some way interfere with the endocrine system, but not necessarily induce
adverse effects”. This definition transmits the notion that there is evidence regarding the mode
of action of the substance (interference with the endocrine system), but not regarding the
induction of adverse effects, which is in line with the terminology of endocrine active
substances. Therefore, we suggest to use the EFSA definition for EAS instead of the EC
roadmap definition.
IV. Introduction of potency as a criterion for hazard identification (Option 4)
Option 4 of the roadmap is based on the WHO/IPCS definition of an ED, with potency as an
added criterion. This option echoes approaches developed by the UK and German authorities
with the explicit intention of limiting the number of substances that would fall under the
hazard-based cut-off criteria of the PPPR and BPR (discussed in Kortenkamp et al. 2011). A
publication from the German Federal institute for risk assessment also suggested to consider
potency to identify EDs (Marx-Stoelting et al. 2015).
Potency is not well-defined; it is not in the glossary of terms of the environmental health
criteria published by the International Program on Chemical Safety (IPCS 2009). The term is
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presented in a publication sponsored by ECETOC, the European Centre for Ecotoxicology
and Toxicology of Chemicals, a non-profit association of companies with interests in the
manufacture and use of chemicals, as being "primarily based on the dose causing a specific
toxic effect" without being clearly defined (Hennes et al. 2014). A publication from the
German Federal institute for risk assessment indicates that “Potency relates to the dose levels
at which certain effects occur.” (Marx-Stoelting et al. 2015). The International Union of
Pharmacology defines potency as “an expression of the activity of a drug, in terms of the
concentration or amount needed to produce a defined effect; an imprecise term that should
always be further defined (see EC50, IC50, etc.)” (where EC50 is further defined as “The molar
concentration of an agonist that produces 50% of the maximal possible effect of that agonist.
Other percentage values (EC20, EC40, etc.) can be specified.”) (Neubig et al. 2003).
Hence, in pharmacology, potency is related to the dose-response function: a substance that at
a certain dose causes 50% of its possible maximal effect magnitude (e.g., rate of animals with
a specific disease) is considered more potent than another substance for which the same effect
magnitude is attained at a larger dose. As already mentioned (Neubig et al. 2003), sometimes
doses other than those leading to 50% of a given effect are used, such as 10% of a given
effect, without apparent scientific justification of how these cut-off values are chosen. Thus,
potency is simply a point of the dose-response function, corresponding to the dose at which
this dose-response function intersects an arbitrary response level (Figure 2A).
Note that the step by step procedure of the EC roadmap (Options 2 and 3) mentions that it is
necessary to « evaluate whether endocrine disruption is due to a specific endocrine-mediated
mode of action and not to a non-specific secondary consequences of other toxic
effects
» (European Commission 2014). Consequently, effects that would occur at very high
doses at which general toxicity is observed would generally not be enough to qualify the
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compound as an ED, without the need to explicitly introduce concepts related to the dose at
which effects occur.
The introduction of potency as a criterion in hazard identification would lead to several
difficulties. First, this concept is not suited for compounds for which non-monotonic dose-
response functions are possible, as is the case for EDs (Vandenberg et al. 2012). Second, the
introduction of potency as a decision criterion may force the establishment of dichotomous
regulatory cut-off values that are entirely arbitrary and not science-based, such that an ED
with a potency of 10 mg/kg/day might be classified as an ED, while an ED with a potency 11
mg/kg/day (hence causing the same effect at an exposure of 11 instead of 10 mg/kg/day)
would not be classified as an ED. Third, potency comparisons are influenced by the effect
magnitude that is chosen to define the doses to be compared (i.e., whether one considers a
10% or a 50% increase, see Figure 2A), and by the health endpoint considered to define
potency. Overall, potency is not a relevant concept for hazard identification.
Even in the context of risk management, potency alone is of little use. Indeed, dose-response
functions, from which potency is defined, are not meaningful alone, and need to be interpreted
in relation to exposure, which allows estimation of the level of risk for a given population
(Figure 1). Low potency compounds with shallow dose-response functions and very frequent
exposures (Figure 2B) may present greater risks at the population level than more potent
chemicals with steep dose-response functions but less frequent exposure (Figure 2C). Well-
established examples illustrating that the dose-response (or potency) cannot be considered
alone to predict risk include airborne fine particulate matter (PM2.5)(WHO 2014) and low
exposures during critical windows of vulnerability like fetal development, such as those
demonstrated for effects of PCBs on intellectual quotient (Jacobson and Jacobson 1996;
Schantz et al. 2003). Accordingly, the EFSA scientific committee stated "… that, to assess
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whether or not a (predefined) level of concern is reached for an ED, potency should not be
used alone but should take account of actual or predicted exposure.” (EFSA Scientific
Committee 2013). Indeed, potency replaces dose-response curves by a single point of the
curve, which results in a strong loss of information. If a risk-based and not hazard-based
management is chosen, the relevant approach is to take into account the variations of the dose-
response function over the whole range of exposures and combine it with actual exposures, for
all relevant health outcomes, i.e. to explicitly perform a risk assessment study – but this goes
beyond the steps required for hazard identification.
In the context of the PPPR and BPR, where some substances are to be regulated mostly on the
basis of their hazard (at least if exposure is not negligible) and not their risk, considering dose-
response functions (or potency) at the step of hazard identification would lead to reintroducing
a logic of risk assessment. The discussion of whether or not the hazard-based logic of the
PPPR and BPR for EDs should be modified into a risk-based regulation is a matter of policy.
If deemed relevant by regulators, risk assessment should not be reintroduced partially (by
considering only a component of risk assessment), nor "by the back door", i.e., indirectly, by
requiring consideration of a criterion related to risk assessment such as potency. Rather, if
necessary, this should be done explicitly, by modifying the legislation.
V. Parallel with hazard identification in the field of carcinogens
Another key argument against adopting criteria for EDs considering potency is consistency
with the identification of other hazards of similar concern, such as carcinogens or
reproductive toxicants. Several other types of chemical hazards are explicitly referred to in the
EU regulation, including carcinogens, mutagens, reprotoxins. Carcinogens are defined as "a
substance or a mixture of substances which induce cancer or increase its incidence.
Substances which have induced benign and malignant tumors in well-performed experimental
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studies on animals are considered also to be presumed or suspected human carcinogens unless
there is strong evidence that the mechanism of tumor formation is not relevant for humans"
(European Parliament 2008). For carcinogens, the EU defines three categories for
carcinogenic substances (1A, 1B and 2, the latter corresponding to suspected carcinogens,
Table 2). The classification of a substance in any category is based on a scientific assessment
of the hazard (hazard identification) and does not take into consideration other components of
the risk assessment scheme (Figure 1) such as "potency". Opting for options 2 or 4 would
separate EDs from other hazards of equivalent concerns because the number of hazard
categories would differ (in the case of Option 2, for which a substance is either identified as
an ED or not, not alerting industry, consumers or policy-makers to
suspected EDs) or because
potency would be considered (Option 4). This would run counter to the policy choice of the
legislation to consider EDs as being of equivalent concern to carcinogens, mutagens and
reprotoxicants. Overall, the example of carcinogens shows that criteria defining a serious
hazard need not be complex, nor need to resort to potency and risk-related concepts.
VI. Impact assessment studies are not designed to help defining hazards
The European Commission is carrying out an impact assessment as a preliminary step before
deciding among the four options. Impact assessment studies provide an assessment of the
potential economic
, social
and
environmental impacts of alternative policy options. They
would make sense if policy options were currently examined (e.g., between hazard-based
regulation of pesticides or risk-based regulation), or after the implementation of a policy to
judge its results. Here the relevant regulations (PPPR, BPR, REACH laws) have already been
enacted but not applied.
Scientific criteria should rely on a scientific foundation. It is not the evaluation of the impact
of a family of compounds that should guide their scientific definition; rather, the adoption of a
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scientific definition conditions any impact evaluation. Continuing the previous parallel with
other health hazards, carcinogens were defined prior to obtaining a clear picture of the number
of existing carcinogens, and independently of their impact. Similarly, it would not be
necessary to perform an impact assessment study before defining X-rays or explosives.
Studies of the impact of some EDs on disease burden and cost in Europe have already been
published (Trasande et al. 2015). The economic cost associated with exposure to non-banned
EDs in the EU was estimated to be 157 billion Euros per year (Trasande et al. 2015).
If option A leads to the identification of 10 substances that are EDs while option B identifies
50 further substances, will option B be preferred to limit the health impact of EDs or will
option A be chosen to limit constraints on the industrial sector? Economic and health impacts
are subject to quick changes as a function of exposure levels, development of substitutes or
alternative industrial processes, existence of companies with relevant substitutes... Will the
impact assessment be updated to take these changes into account, and the criteria modified
accordingly?
In its ruling against the European Commission, the European court of justice stated that "the
definition of scientific criteria to identify properties disrupting the endocrine system can only
be done in an objective manner based on scientific data relative to the endocrine system,
independently from any other consideration, and in particular from any economic
consideration." (European Court of Justice 2015). Making a scientific definition dependent on
the results of an assessment of its impact would be a dangerous precedent for public health
and science in general.
Conclusion
The laws passed by the European parliament during the last decade constitute an innovative
approach to limit health risks posed by EDs.
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We have presented and discussed each option proposed by the European Commission to
identify EDs (European Commission 2014), and provided specific recommendations (Table
3). Only options 2 and 3 comply with science. There is scientific consensus on the relevance
of the WHO/IPCS definition of an ED (WHO/IPCS 2002). Option 4 modifies this definition
by introducing the notion of potency, which is absent from the WHO/IPCS definition and
from the criteria identifying carcinogens, which are hazards of equivalent concern to EDs. We
believe that, because of the parallel with definitions of carcinogenic hazards (which have
different categories based on evidence levels) and because it calls for the identification of
suspected EDs, Option 3 is more relevant. This will provide a simple classification conveying
the weight of the scientific evidence regarding the likelihood for the compound to be an ED:
endocrine disruptors (expressing certainty), suspected endocrine disruptors, and endocrine
active substances (see Table 2).
We recognize that scientific uncertainty remains with regard to the finer detail of mechanisms,
the exact extent of health and environmental effects of EDs and their impact at the population
level. There are also great uncertainties as to the number of substances likely to be identified
as EDs. However, as demonstrated by the 40 years of work by the International Agency for
Research on Cancer to identify carcinogens (Pearce et al. 2015), the availability of a clear
definition of the hazard considered is a necessary first step. Once defining criteria are
available, one can develop appropriate testing methods, identify substances and manage risk.
Some of the test methods that will be required for regulatory purposes need to be developed
and agreed upon.
There is no scientific or public health justification for the delay in the adoption of scientific
criteria for EDs.
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As scientists, we believe that impact assessment studies should not be used to define scientific
criteria, nor be used as an argument for postponing the publication of a scientific definition.
We are concerned that an impact assessment study could be used to bend science towards an
outcome defined by aspects external to science. We are convinced that the (vague) notion of
potency has no place in a hazard identification context. We are concerned that scientific
definitions are being distorted in order to modify the spirit of a law which requires hazard-
based management of EDs present in pesticides and biocides if exposure is not negligible, and
not a risk-based management, thereby muddling science and policy. We believe that scientific
criteria identifying EDs should follow the logic of the EU criteria for other serious hazards
such as carcinogens and reproductive toxicants. We regret that several years have been spent
on trying to issue scientific criteria defining a hazard that actually has been defined years
earlier by a state-of-the-science report from WHO. We fear that the most plausible
explanation for this delay is not a lack of scientific consensus but rather that postponing the
publication of the scientific criteria is a way to postpone the full application of the 2009
pesticide regulation and 2012 biocide European regulation. This postponement is all the more
worrying since these scientific criteria are but one of the first steps towards identifying EDs
and providing more efficient protection of public health in the European Union.
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Table 1: Four options to identify endocrine-disrupting substances in the EC 2014 roadmap (European Commission 2014).
Option Details
Comments
1
No criteria are specified. The interim criteria set in the BPR and PPPR continue to apply.
Would run counter the PPPR and
BPR, which require scientific criteria
to be defined. Would lead to the
interim criteria (which are not
coherent with the WHO/IPCS (2002)
definition of EDs) to be used.
2
WHO/IPCS definition (WHO/IPCS 2002) to identify ED (hazard identification). ED are identified as:
a) Substances which are i) known or presumed to have caused endocrine-mediated adverse effects in humans or
population-relevant endocrine-mediated adverse effects in animal species living in the environment or ii) where
there is evidence from experimental studies (in vivo), possibly supported with other information (e.g. (Q)SAR,
analogue and category approaches) to provide a strong presumption that the substance has the capacity to cause
endocrine-mediated adverse effects in humans or population-relevant endocrine-mediated adverse effects on
animal species living in the environment;
b) the experimental studies used to determine if a substance is an endocrine disruptor shall provide clear
evidence of endocrine-mediated adverse effects in the absence of other toxic effects, or if occurring together
with other toxic effects, the endocrine-mediated adverse effects should not be a non-specific secondary
consequence of other toxic effects;
c) An adverse effects is a change in the morphology, physiology, growth, development, reproduction, or, life
span of an organism, system, or (sub)population that results in an impairment of functional capacity, an
impairment of the capacity to compensate for additional stress, or an increase in susceptibility to other
influences, as stated in (WHO/IPCS 2009);
d) where there is (e.g. mechanistic) information demonstrating that the effects are clearly not relevant for
humans and not relevant at population level to animal species living in the environment, then the substance
should not be considered an endocrine disruptor;
e) The identification shall follow a step by step procedure as follows: i) gather all available data; ii) assess the
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data quality, reliability, reproducibility and consistency; iii) consider adversity and mode of action together in a
weight of evidence approach based on expert judgment; iv) evaluate whether endocrine disruption is due to a
specific endocrine-mediated mode of action and not to a non-specific secondary consequences of other toxic
effects; v) evaluate human and wildlife relevance; vi) final (eco)toxicological evaluation indicating, where
possible, whether the adverse effect is in relation to human health or environment (vertebrates and/or
invertebrate populations), and where possible which are the axes or mechanisms concerned (e.g. estrogenic,
androgenic, thyroid and/or steroidogenic axes)
3
WHO/IPCS definition (WHO/IPCS 2002) to identify ED (hazard identification) as in option 2. Introduction of The definition of
endocrine active
additional categories based on the different strength of evidence for fulfilling the WHO/IPCS definition:
substances (category III) does not
Category I: endocrine disruptors (as defined in 2a-2d).
follow the definition provided by
Category II: suspected endocrine disruptors, defined as substances where there is some evidence for EFSA, which refers to substances that
endocrine-mediated adverse effects from humans, animal species living in the environment or from can interfere or react with the
experimental studies, but where the evidence is not sufficiently strong to place the substance in Category I. If, endocrine system (without evidence of
for example, limitations in the studies make the quality of evidence less convincing, Category II could be more adverse effect).
appropriate. Points 2b, 2c (definition of adverse effect) and 2d above remain valid for Category II.
Category III: endocrine active substances, defined as substances for which there is some in vitro or in vivo
evidence indicating a potential for endocrine disruption mediated adverse effects in intact organisms and where
the evidence is not sufficiently convincing to place the substance in category I or II.
The allocation to categories shall follow a step-by-step procedure (identical to that listed in 2e above).
4
WHO/IPCS definition (WHO/IPCS 2002) to identify ED (hazard identification) and inclusion of potency as Potency is not defined. Option 4
element of hazard characterization
introduces elements of risk
assessment. No step-by-step procedure
provided as in 2 and 3.
BPR: Biocide Products Regulation (EU); PPPR: Plant Protection Products Regulation (EU).
24
Environ Health Perspect DOI: 10.1289/EHP217
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Table 2: Categories of carcinogenic substances, as defined by the EU CLP regulation (EC, No. 1272/2008 on classification, labeling and
packaging of substances and mixtures). In the right-hand column, we have added the 3 levels for EDs proposed in Option 3 of the European
Commission roadmap (2014).
Carcinogens (a)
Endocrine Disrupting Chemicals (option 3 of the EC Roadmap)
Hazard Class
Hazard
Class
Category 1A
Substances known to have carcinogenic potential for
I
humans (b)
Substances known to be an endocrine disruptor
Category 1B
Substances presumed to have carcinogenic potential for
humans (b)
II
Suspected endocrine disruptors
Category 2
Suspected human carcinogens (c)
III
Endocrine active substances
a. A carcinogen is defined as a substance or a mixture of substances which induce cancer or increase its incidence. Substances which have
induced benign and malignant tumors in well performed experimental studies on animals are considered also to be presumed or suspected human
carcinogens unless there is strong evidence that the mechanism of tumor formation is not relevant for humans (European Parliament 2008) .
b. A substance is classified in Category 1 for carcinogenicity on the basis of epidemiological and/or animal data. A substance may be further
distinguished as: Category 1A, known to have carcinogenic potential for humans, classification is largely based on human evidence, or category
1B, presumed to have carcinogenic potential for humans, classification is largely based on animal evidence.
c. According to the EU regulation, the placing of a substance in Category 2 (Suspected human carcinogens) is done on the basis of evidence
obtained from human and/or animal studies, but which is not sufficiently convincing to place the substance in Category 1A or 1B, based on
strength of evidence together with additional considerations. Such evidence may be derived either from limited evidence of carcinogenicity in
human studies or from limited evidence of carcinogenicity in animal studies.
25
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Table 3: Recommendations.
RECOMMENDATION
RATIONALE
1. Refer to the WHO/IPCS (2002) definition of
Follow scientific consensus.
EDs, potential (suspected) ED, and adverse effects;
and to the EFSA definition of endocrine active
substances.
2. Identify hazards without referring to potency.
Potency is poorly defined, endpoint
dependent, is not used to define other
hazards of equivalent concern such as
carcinogens and belongs to risk
assessment, not hazard identification.
Any change in the spirit of the law
3. Consider hazard identification and risk
should be done explicitly in the law,
characterization as separate issues. Do not use
scientific criteria to move from a hazard-based to a not via a delegate act.
risk-based regulation for specific substances
4. Establish scientific ED criteria irrespective of an Impact assessment studies are not
impact assessment study
meant to provide scientific definitions.
5. Incorporate the level of evidence in
Proven to be relevant for carcinogens
characterization of EDs (option 3)
and other hazardous substances of
equivalent concern to EDs.
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Figure Legends
Figure 1: Hazard-based versus risk-based management of hazards. Note that the step of risk
characterization is sometimes (ambiguously) termed hazard characterization.
Figure 2: Illustration of issues with the potency concept with hypothetical dose-response
functions and distributions of exposure.
A) Situation of dose-response functions that cross: If
potency is defined as the dose ED50 leading to 50% of a given response, then chemical with
the dose-response function
a is considered more potent than chemical with exposure-response
function
b; if potency is defined as the dose leading to 10% of the response (ED10), then
chemical with dose-response
a is less potent than chemical with exposure-response
b.
B) Shallow dose-response function (and low potency) with a large proportion of highly exposed
subjects, hence entailing a possibly high risk.
C) Steep dose-response function (and high
potency) with a low proportion of highly exposed subjects, hence entailing a possibly similar
or lower risk. Blue bars in B) and C) represent the distribution of exposure in the population.
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Figure 1.
28
Date: Thu, 21 Apr 2016 10:07:31 +0100
Subject: Re: meeting with Commissioner May 3
From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
To: "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx>
CC: "Greim, Helmut"
"Heslop-Harrison, Pat (Prof.)" <xxxx@xxxxxxxxx.xx.xx>,
"xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx" <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx>,
"xxxxxx@xxxx.xxxxxxxxxxxxx.xx" <xxxxxx@xxxx.xxxxxxxxxxxxx.xx>,
Thanks Alan, Helmut
I'm also now booked into
Richard
On 21/04/2016 09:34, "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx> wrote:
>Richard
>
>A number of us are staying at
>
>Best wishes,
>
>Alan
>
>Sent from my iPhone
>
>> On 21 Apr 2016, at 10:32, SHARPE Richard <x.xxxxxx@xx.xx.xx> wrote:
>>
>> Which hotel(s) are you guys staying at?
>> Richard
>>
>>> On 20/04/2016 08:31, "Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx> wrote:
>>>
>>> Helmut
>>>
>>> Many thanks indeed.
>>>
>>> Best wishes,
>>>
>>> Alan
>>>
>>> ________________________________________
>>> From: Greim, Helmut
>>> Sent: 20 April 2016 08:02
>>> To: Heslop-Harrison, Pat (Prof.)
>>> Cc: Boobis, Alan R; xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx;
>>> xxxxxx@xxxx.xxxxxxxxxxxxx.xx; x.xxxxxx@xx.xx.xx;
>>>
>>> Subject: RE: meeting with Commissioner May 3
>>>
>>> Dear all,
>>
>>
>> --
>> The University of Edinburgh is a charitable body, registered in
>> Scotland, with registration number SC005336.
>>
Date: Tue, 19 Apr 2016 13:41:28 +0100
Subject: Re: meeting with Commissioner May 3
From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
To: "Greim, Helmut"
,
"Boobis, Alan R" <x.xxxxxx@xxxxxxxx.xx.xx>
CC: "xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx" <xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx>,
"xxxxxx@xxxx.xxxxxxxxxxxxx.xx" <xxxxxx@xxxx.xxxxxxxxxxxxx.xx>,
"xxxx@xxxxxxxxx.xx.xx" <xxxx@xxxxxxxxx.xx.xx>,
"xxxxx@xxxxxxxxxxxxx.xx.xx" xxxxx@xxxxxxxxxxxxx.xx.xx
There is a chance I may be able to make next Tuesday 17:00 CET, but I am
at an important meeting from 13.30 in another location and with no clear
idea of what time it will finish.
Best wishes
Richard
On 19/04/2016 13:02, "Greim, Helmut" <
>
wrote:
>Dear all,
>Helmut
>
>Am 19.04.2016 13:54, schrieb Boobis, Alan R:
>> Helmut
>>
>> My apologies, but I will be at WHO meeting in Geneva on Friday
>> (possibly available for a call at 17:00 CET at the airport). Monday
>> and Tuesday next week I am tied up chairing the SAB for an EU project.
>> Again, possibly available at 17:00 on Tuesday from the airport.
>>
>> Best wishes,
>>
>> Alan
>>
>> -----Original Message-----
>> From: Greim, Helmut
>> Sent: 19 April 2016 12:33
>> To: Boobis, Alan R <x.xxxxxx@xxxxxxxx.xx.xx>;
>> xxxxxx.xxxxxxxx@xxxxxxxxxxxx.xx; xxxxxx@xxxx.xxxxxxxxxxxxx.xx;
>> xxxx@xxxxxxxxx.xx.xx; x.xxxxxx@xx.xx.xx;
>> Subject: meeting with Commissioner May 3
>>
>> Dear all,
>> Helmut
>
Date: Thu, 7 Apr 2016 10:02:11 +0100
Subject: Re: Meeting with Commissioner May 3
From: SHARPE Richard <x.xxxxxx@xx.xx.xx>
To: "Greim, Helmut"
,
Colin Berry <xxxxx@xxxxxxxxxxxxx.xx.xx>
CC: "x.xxxxxx@xxxxxxxx.xx.xx" <x.xxxxxx@xxxxxxxx.xx.xx>,
"xxxx@xxxxxxxxx.xx.xx" <xxxx@xxxxxxxxx.xx.xx>
Hi Helmut
I have just replied to
and said I can attend (depending on funding)
on May 3-4 and happy to participate also in the meeting with Dr.
Andriukaitis of DG Sante.
Best wishes
Richard
On 07/04/2016 09:58, "Greim, Helmut" <
>
wrote:
>Dear Colin,
>Helmut
>
>Am 07.04.2016 10:24, schrieb Colin Berry:
>> Dear All,
>> I am sorry that I am committed In London until late on the 3rd. Is
>> it worth my coming for this meeting only on the 4th? I would need
>> support for my fare.
>> Colin Berry
>>
>> -----Original Message-----
>> From: Greim, Helmut
>> Sent: Wednesday, April 6, 2016 3:22 PM
>> To: Colin Berry; x.xxxxxx@xx.xx.xx; x.xxxxxx@xxxxxxxx.xx.xx;
>> xxxx@xxxxxxxxx.xx.xx
>> Subject: Meeting with Commissioner May 3
>>
>> Dear all,
>>
>>
>> Sincerely,
>> Helmut
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