Opinion

Members of the Steering Committee of BelTox agreed to write a letter to the editor of the journal “Food and Chemical Toxicology” on October 9th to express their concern about the very low scientific quality of a publication written by Gilles-Eric Séralini et al. entitled: “Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize” of which the results received a lot of publicity in Europe.


 

Despite the many protest letters that were sent by the scientific community to the editorial board of the journal, the decision was made to publish the article anyway. Below you can find the text of our letter. This is the first time that BelTox issued a scientific opinion on a toxicological issue.  


To Dr Wallace Hayes,
Editor, Food and Chemical Toxicology

9 October 2012

 

Dear Dr Hayes,

 

The publication of Séralini et al. (2012) came to our attention because of the shocking photographs of rats with huge masses that were shown in the media in Europe. This has a spectacular effect on the public opinion but is scientifically not common practice to correctly report the outcome of a toxicology study. As members of the Steering Committee of the Belgian Society of Toxicology and Ecotoxicology, a national scientific society, this triggered our curiosity and we all went through the publication with great attention.

 

The authors conducted a long term toxicology study (2 years) to compare the health status of rats fed genetically modified (GM) corn, GM corn treated with Roundup and several concentrations of Roundup in water with a control group fed near isogenic non-GM corn in the diet.

 

As recently published by Snell et al. in Food and Chemical Toxicology, the commonly accepted view is that “GM plants are nutritionally equivalent to their non-GM counterparts and can be safely used in food and feed”.

Challenging existing knowledge and paradigms is of course the basis of scientific progress, and re-visiting those current views might be appropriate and welcome.

 

Unfortunately, we came to the conclusion that these objectives were not met because of the poor scientific quality of the study. The study contrasts with the current best practices in the design, conduct, reporting and interpretation of long term toxicology studies as approved by national and international regulatory bodies. The conclusions drawn by the authors are not supported by the results generated by their bioassay. It was therefore a great surprise to us that this manuscript passed through the Journal’s review process.

 

We point out some of the numerous flaws in the paper of Séralini et al.:

 

   There were 9 test groups and one control group with only 10 rats/sex/group. This is a major deviation from the OECD test guidelines which recommend using at least 50 rats/sex/group to achieve a sufficient statistical power and to rule out chance findings

 

   The high incidence of mammary and pituitary tumors is a common feature in SD rats and can only be dealt with by using test groups of at least 50 rats/sex/group and a large control group if a solid in-lab historical database is not available

 

   No detail is provided on the nutritional balance of the diets in the test groups

   No determination of mycotoxin residues in the corn was made
   No determination of glyphosate and AMPA residues in the Roundup treated GM corn was made

   The animals exposed to the dilutions of Roundup received “control” diet, it is not clear whether this was standard lab chow (the European one?) or the diet containing 33% near-isogenic non-GM corn

 

   There is no mention that the animals were kept under SPF conditions

 

   It is not clear whether the test was conducted under GLP conditions

 

   It is difficult to understand why the rats were exposed to the lowest dilutions of Roundup (glyphosate + surfactant) since the ratio of glyphosate/surfactant changes after application on the corn due to different rates and pathways of degradation

 

   The authors state that “all data cannot be shown in one report”. That is true, but they could at least have shown summarized data tables, as normally reported in regulatory toxicology studies

 

   The proposal of a “threshold” effect for mortality at low doses is speculative and certainly not demonstrated by the data

 

   The reporting of the number of tumors per animal is not common practice in cancer studies. What is done is the calculation of the incidence (number of rats with the tumor vs. number of rats examined) per tumor type which is only determined histopathologically and the positive findings submitted to peer review by independent histopathologists

 

   By just looking at the bar charts with the total number of tumors per test group, we do not see any dose/response relationship, and it is difficult to follow the discussion and the conclusions of the authors

 

   Reporting of pathology data in Table 2 is very unclear

 

   The statistical analysis of the data is also problematic. The most critical data, i.e. mortality and tumor occurrence were not (could not be because of the small sample size) analyzed statistically and the conclusion of an increased incidence of tumors cannot be drawn from the presented data. In contrast, the statistical methods applied for the analysis of some of the other data (PCA, PLS, OPLS, …) are unusual and do not support the conclusion drawn by the authors.

 

To conclude, from a scientific point of view, it is difficult (if not impossible) to draw sound conclusions from this publication.

 

The controversy fueled by this publication is confusing for the consumer but also causes damage to the scientific community. The trust of the public and of competent national and European authorities in peer-reviewed scientific publications has been seriously affected by this episode.

 
Sincerely,

Dr. Marie-Noëlle Blaude, Dr. Miranda Cornet, Dr. Arno Gutleb, Prof. Dr. Peter Hoet, Prof. Dr. Patrick Kestemont, Prof. Dr. Dominique Lison, Dr. Mark Martens, Dr. Francesca Tencalla, Dr. Koen Van Deun, Ir. Henk Vrijhof, Dr. Willem Penning

 
Members of the Steering Committee of the Belgian Society of Toxicology and Ecotoxicology

Advanced Course Genotoxicity & Mutagenicity Testing – program and itinerary

 

Advance Course

Genotoxicity & mutagenicity testing: a brief overview of the main tests, pitfalls and regulatory framework.

Elewijt (Elewijt center), 04 October 2012

Program

9.00
 
Welcome
 
 
9.10
 
General introduction, Genotoxicity testing at the right position in hazard evaluation. Peter Hoet & Lode Godderis (KU Leuven, BelTox & Bems)
 
9.20 Background & mechanisms Ilse Decordier (VUB)
 
10.30

Break (coffee & thee)


 
11.00
 
Genotoxicity testing: an introduction to the different
test systems
 
Ilse Koijen / Bas-jan van der Leede (Janssen R&D)
 
11.45
 
Regulatory aspects (OECD, ICH, REACH):
 
Sonja Beken (FAMHP)
12.15

Lunch  
13:15
 
False positives and strategies of testing Philippe Vanparys (Altoxicon Bvba)
 
13.45
 
Exercise / case study: Introduction & questions to solve Ilse Koijen / Bas-jan van der Leede, (Janssen R&D)
 
14.00 Exercise / case study: study in subgroups
(coffee and thee available)
 
expert assistance
16.00 Interactive overview of the cases
(comparing/discussing outcomes per group)
 

16.30
 
Final remarks and adjournments
 
 

Organizing committee:
BEMS: Lode Godderis, Freddy Van Goethem –
BelTox: Philip Vanparys, Peter Hoet

You can download the preliminary program with the attachments below.

Itinerary:

Roadworks are planned around the Elewijt Center at the time of the seminar . In attachment you can download an alternative itinerary to reach the venue.

Biopharmaceuticals workshop 22/11/2012: Itinerary and accommodation

Please take into account that you will need to check-in with security at the reception desk, you therefore need to arrive 15 minutes before the start of the event.

VENUE

UCB
Visitors entrance
Avenue de l'Industrie
B-1420 Braine-l'Alleud, Belgium
Tel.: +32 2 386 40 40

 

ITINERARY

  • By car
    • Attached are the instructions how to reach UCB by road.
    • At the reception you will be shown the way to the visitors parking and the meeting point on the site map.
  • By train
ACCOMMODATION
Hotels nearest to UCB (the list below can be downloaded with the attachement at the bottom of this page):

TAXISERVICES for transport from your hotel to UCB:

2nd Workshop on Non-Clinical Safety Assessment of Biopharmaceuticals

Thursday 22 November 2012 – UCB Pharma, Braine l'Alleud, Belgium
Preliminary Program

 

You can download this program from the pdf in attachment at the bottom of this page.

8:30-9:00
 
Coffee
 
 
9:00-9:10
 
Welcome
 

 
Morning session: Introductory lectures

9:10-10:10
 
Vaccine Regulatory Toxicology – update on
recent EMA and WHO guideline revisions
 
C. Herberts,
Medicines Evaluation Board, Nl
 
10:10-10:30
 
Coffee break

 


 
10:30-11:15 Different approaches in DART testing driven by
biopharmaceutical subclasses
 
M. Beekhuijzen,
WIL Research, Nl
11:15-12:00
 
Juvenile toxicology for biopharmaceuticals

 

P. Baldrick,
Covance, UK
 
12:00-13:00
 
Lunch and networking
 
 
Afternoon session: Case studies
(chair : J. Sims, Integrated Biologix, UK)

13:00-13:15
 
Introduction to breakout sessions A. Cauvin,
UCB Pharma, B
 
13:15-14:30 Breakout sessions
 
14:30-14:50
 
Coffee break
 
 
14:50-16:50
 
Case study reporting and discussion
 
participants
 
16:50-17:00
 
Concluding remarks
 
 
Organising Committee : Judith Baumeister (Ablynx), Annick Cauvin (UCB Pharma),
Miranda Cornet (UCB Pharma), Michaela Damsten (GSK Vaccines), 
Ilham Smyej (Johnson & Johnson), Lawrence Segal (GSK Vaccines)
with the technical assistance of Marleen Hallam (BelTox) and Catherine Vos (UCB Pharma)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Joint BELTOX-INVITROM congress 2012: Program

"Reproductive Toxicology:
from In Vitro to Human"

 3 December 2012

Hotel Ter Elst, Edegem (Belgium)

(To download the program, use the attachment at the bottom of this page)
8:30 – 8:55
 
Registration and coffee

8:55 – 9:00
 
Welcome
Mark Martens (president BelTox)
 
Morning session – Chair: Mark Martens

9:00 – 9:45 Overview of reproductive toxicology
Aldert Piersma (RIVM, The Netherlands)
 
9:45 – 10:30
 
Disturbances in embryofetal development and clinical outcome
Steven Van Cruchten (University Antwerp, Belgium)
 
10:30 – 11:00
 
Coffee break and poster session

11:00 – 11:30 Current developments in in vivo reproductive testing
Andre Wolterbeek (TNO, The Netherlands)
 
11:30 – 12:00 The zebrafish embryo as an alternative model for developmental toxicity and neurotoxicity testing
Ingrid Selderslaghs (VITO, Belgium)
 
12:00 – 13:30 Walking lunch and poster session
12:15 : General Assembly for BelTox members
12:30: General Assembly for INVITROM members

Afternoon session – Chair: Bas Blaauboer (president INVITROM)

13:30 – 14:00
 
Integrated in vitro-in silico models for predicting in vivo developmental toxicity.

Miriam Verwei (TNO, The Netherlands)
 

14:00 – 14:30
 
In vitro toxicity testing with oocytes and spermatocytes
Rita Cortvrindt (EggCentris, Belgium)
 
14:30 – 15:00
 
Coffee break and poster session
15:00 – 16:00
 
Young Scientist Forum
 
16:00 – 16:45
 
How do we integrate different data types?
Robert Chapin (Pfizer, USA)
 
16:45 – 17:00
 
Proclamation of winning  posters of young scientists
Bas Blaauboer and Mark Martens
 
17:00
 
Closing remarks
Bas Blaauboer

Itinerary to the Lamot Center.

By car from Brussels/Antwerp

Follow the E19 Brussels-Antwerp and take exit 9. Follow direction Mechelen. At the Mc Donalds, turn right. Cross the viaduct until the first traffic lights where you turn left into the Adegemstraat. At the end of the Adegemstraat turn left. After 7 meters, you will notice on your left brasserie “Puro” as well as the entrance of public parking Q-Park “LAMOT” (open 24/24). Lamot is located next to Novotel Mechelen Center. The main entrance is located on the Haverwerf.

By car from Leuven via Leuvensesteenweg

Follow the signs “Mechelen-Centrum” until the ringroad. Turn left and follow the ringroad until the Brusselpoort (monument). Continue until the crossing where you turn right into Adegemstraat. At the end of the Adegemstraat turn left. After 7 meters, you will notice on your left brasserie “Puro” as well as the entrance of public parking Q-Park “LAMOT” (open 24/24). Lamot is located next to Novotel Mechelen Center. The main entrance is located on the Haverwerf.

By public transport

Train: There are two stations in Mechelen: 1) the central station “Mechelen” where international, national, regional and local trains stop. 2) the smaller station “Nekkerspoel” where only regional and local trains stop.
By bus from Mechelen station: at platform 1 you take bus 4 “Mechelen Station – Leest”. This bus leaves every half hour (6.40 h – 7.10 h – 7.40h …last departure at 20.10 h) on weekdays and Saturdays. Get off at busstop “Korenmarkt”. You are now within walking distance of the Lamot entrance.

By foot from the station (Koning Albertplein)

Follow the Hendrik Consiencestraat until the traffic lights. Cross over and follow the Kardinaal Mercierplein (66 m). Follow the Graaf van Egmontstraat (140 m). At the end of the Graaf Van Emontstraat turn left into the Onze-Lieve Vrouwestraat. The Onze-Lieve-Vrouwestraat ends into the Korenmarkt, where you turn right into the Guldenstraat. At your left hand side, you will see brasserie “Puro”. You follow this street until you arrive at the Haverwerf, where you will see the main entrance of the Lamot Center..

Annual Meeting 2011: Program

"Trends in Metals Toxicity and Ecotoxicity"

BelTox Annual Scientific Meeting, 8 December 2011

Lamot Conference Center, Mechelen

(To download the program, use the attachment at the bottom of this page)
8:30 – 9:00
 
Registration and welcome

Morning Session – Chair: Francesca Tencalla

9:00 – 9:05
 
Welcome
Mark Martens (President BELTOX)
 
9:05 – 10:00 Keynote lecture:
Metals: Looking forward based on the REACH experience
Colin Janssen (UGhent) and Violaine Verougstraete (Eurometaux)
 
10:00 – 10:30
 
Coffee Break & Poster Session
 
10:30 – 12:15
 
Young Scientist competition
7 x 15 min presentations
 

12:15- 12:30
12:30 – 13:30
 

Election of the new BelTox Steering Committee
Lunch and Poster Session
Afternoon Session – Chair: Patrick Kestemont

13:30 – 14:00
 
Environmental bioavailability
Patrick van Sprang (ARCHE consulting)
 
14:00 – 14:30
 
Bioaccessibility Testing and Its Application to Read-across
for hazard assessment and risk characterisation of metals

Adriana Oller (Nickel Institute)
 
14:30 – 15:00
 
Particularities of metals testing
Rodger Battersby (EBRC)
 
15:30 – 16:00
 
Coffee Break and Poster Session
 
16:00 – 16:30
 
From observations to toxicogenomic responses of toxic metal exposure in the population
Tim Nawrot (University of Hasselt)
 
16:30 – 17:00
 
Case study: Cobalt-toxicology as a driver for product development
Steven Verbeckmoes (Umicore)
 
17:00 – 17:30

Proclamation of winning presentations and posters

17:30
 
Closing comments – Dominique Lison
 

Micheline’s Life Cycle

You can download the program of the symposium in honour of the emeritate of Prof. Dr. M. Volders from the attachment below.

AM 2011: Young Scientists Competition

BelTox is organising its annual scientific meeting on December 08, 2011.

During this meeting, an oral and poster competition will be organized for PhD students presenting their results in the diverse fields of toxicology and ecotoxicology in Belgium.

If you would like to compete you are invited to submit an abstract online on this website using THIS LINK, where you can find an example of an abstract and further instructions on the format. The organising committee for this year’s annual meeting will select the 6 most appealing abstracts for oral presentations. The other accepted abstracts will be presented as posters. The deadline for sending the abstracts is 31 October 2011. Three weeks in advance of the annual meeting you will be informed whether you are invited to give either a 10 min oral presentation or to present your work in the poster session. During the meeting, the oral presentations and the posters will be evaluated by the invited speakers and members of the Steering Committee of BelTox. The best and second best oral presentations as well as the best and second best posters will receive a prize. The prize is 200 Euro for the best and 100 Euro for the second best scientific communication.

The subject of the abstract does not necessarily need to relate to the Annual Meeting's theme but can relate to any aspect of toxicology or ecotoxicology.

The venue of the meeting is the Lamot auditorium, Van Beethovenstraat 8/10, 2800 Mechelen, Belgium 

This meeting will, no doubt, be a unique opportunity for young researchers to communicate their results to an audience of experienced scientists from both academic and professional sectors and to exchange experiences with colleagues. For the other participants it will be a good opportunity to meet with the leading scientists of tomorrow.

Please mark your agenda for this stimulating event.

The participation fee for the whole annual meeting is 30 Euro for PhD students (which includes BelTox membership for 2011/2012) and 10 Euro for MSc students. Registration fee includes coffee break and sandwich lunch.

We are looking forward to meeting you soon.

Dr Francesca Tencalla and Prof. Dominique Lison
on behalf of the organising committee of the BelTox Annual Meeting

BEMS mission statement

The BEMS is the Belgian Environmental Mutagen Society. The members are scientists who share the passion of studying “cancer and environment” and individuals who want to learn more about this important topic.
The aims of the society are:
– To disseminate knowledge by means of scientific meetings and to share scientific expertise amongst its members
– To promote and to encourage research on the genetic and non-genetic effects of environmental carcinogens, on their detection in exposed humans and on the mechanisms in the development towards cancer (carcinogenesis).
– To provide scientific assistance to official authorities and private industries in the field of environmental mutagenesis.
The society was founded in October 1980 and together with other European national Societies, it constitutes the European Environmental Mutagen Society (EEMS). The EEMS is part of the International Association of Environmental Mutagen Societies (IAEMS)