ISIS Report 09/07/14
Scandal of Glyphosate Re-assessment in Europe
EU rapporteur state Germany recommends re-approval with daily
intake increased by 67 %; its re-assessment was carried out by Monsanto and a
consortium of chemical companies in Europe based almost entirely on studies
from industry; it should be rejected outright Dr Nancy Swanson and Dr Mae
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Preposterous verdict of “acceptable” risks for glyphosate
acting as the European Union rapporteur member state (RMS) submitted their
glyphosate renewal assessment report (RAR) to the European Food Safety
Authority (EFSA) in January 2014, recommending re-approval of glyphosate for
use in Europe with increase in the acceptable daily intake (ADI) from 0.3 to
0.5 mg per kg body weight per day .
overall findings of the RAR are that glyphosate poses no unacceptable risks.
Glyphosate is not metabolized or accumulated in the body, not genotoxic, not
carcinogenic, not endocrine disrupting, and not considered persistent or
bioaccumulative; it has no reproductive toxicity, no toxic effects on
hormone-producing or hormone-dependent organs, and no unacceptable effect on
bees. Therefore any risks are within acceptable standards. The only risks
noted were that glyphosate is a severe eye irritant and is persistent in soil.
Issues that could not
be finalized in the assessment were: relevance of impurities, effects on
microorganisms, effects on non-targeted plants, and indirect effects on
biodiversity - non-targeted organisms, particularly birds.
The Proposed Decision at
the end of Vol. 1 is completely blacked out.
conclusion amid overwhelming evidence of toxicities
they arrive at such a preposterous conclusion when the evidence for glyphosate
herbicides toxicity has accumulated worldwide to such an extent that a number
of countries are already banning its use? Denmark took the lead to ban the
herbicide back in 2003  The Dutch Parliament banned it in April 2014 for
non-commercial use , to take effect by the end of 2015; France is set to
follow. Brazil, one of the largest growers of glyphosate-tolerant genetically
modified (GM) crops has now filed a law suit by Federal Prosecutors to ban
glyphosate along with 8 other dangerous pesticides . El Salvador imposed a
complete ban in February 2013, linking glyphosate herbicides to an epidemic of
chronic kidney disease that has struck the region . Sri Lanka’s scientists
have provided evidence for glyphosate accumulation in the body especially in
the presence of hard water. Its ability to capture and retain arsenic and
nephrotoxic metals enables it to act as a carrier to deliver the toxins to the
kidney  (see  Sri Lanka Partially Bans Glyphosate
for Deadly Kidney Disease Epidemic,
SiS 62). The Sri Lankan government initially instituted a ban, but
reneged under pressure from industry .
Glyphosate has also been linked to many other health
problems including cancers (see  Glyphosate and Cancer, SiS 62), infertility (see  Glyphosate/Roundup & Human Male
Infertility, SiS 62), along with neurotoxicity, reproductive problems,
birth defects, genotoxicity, and other human health problems as well as
ecotoxicity (see  Ban GMOs Now, special
ISIS report), and many have considered a world-wide ban long overdue.
restrictive electronic-only and biased comment process
EFSA had put the RAR on their
website for public consultation, which ended 11 May 2014. The response was
electronic only on a rigid template with predetermined categories of answers, and
severe limitations on space. Neither e-mail, nor ordinary mail was accepted.
Commenters had to sign an agreement to have their comments deleted if deemed
unsuitable. Thus, all comments relating to Roundup were ignored, even though
Roundup is the most widely used glyphosate herbicide in Europe. The consultation
was strictly limited to pure glyphosate. Dr Brian John of GM-Free Cymru lodged
a complaint with the European Ombudsman saying that EFSA had no right to impose
those conditions, accusing the process of being  “biased, and heavily
weighted towards those who want to see glyphosate continue in use” and
“entirely unfit for purpose.”
entire process of risk assessment was also completely non-transparent.
Who were the authors of the risk
Federal Institute for Risk Assessment (BfR-- Bundesinstitut für
Risikobewertung) is responsible for the RAR. There is no information on
authorship anywhere within the 15 documents totalling 3 744 pages .
Between April and June of 2014, the BfR was contacted and asked on four separate occasions to provide information on
who authored the report and which committee at BfR was responsible for the
report. To date, they have not responded.
The BfR Committee for
Pesticides and Their Residues (CPTR), which might be expected to be responsible
for preparing the RAR, has 3 out of 12 of its 2014 members and 4 out of its 16 2011-2013
members from either BASF or Bayer CropScience [14, 15]. This serious conflict
of interest in a regulatory agency is not restricted to BfR, it is endemic to
the EU regulatory agency.
EFSA has a history of
conflicts of interest. The Corporate Europe Observatory report 'Unhappy Meal' published in October 2013 ,
revealed that some 59 % of EFSA's scientific panel members still had direct or
indirect links to companies whose activities fell under EFSA’s remit. As a
result the European Parliament voted in April 2014 for a resolution to ban
scientists with ties to the agriculture and food industries from working at the
agency, and has given EFSA two years to clean up its act .
But the conflict of
interest is even more blatant than anyone could have imagined. It is Monsanto
and a consortium of European chemical companies that performed the risk
assessment for the re-approval of glyphosate.
& a consortium of European chemical companies did the risk assessment
BfR stated in its press release : “Apart from the BfR,
other institutes involved in the new assessment of glyphosate were the Federal
Environment Agency, the Julius Kühn Institute and the Federal Office of
Consumer Protection and Food Safety, the latter as risk management authority.”
That was designed to add undue respectability and gravitas to the risk
and its federal agency partners did not actually review the published
toxicology studies. Instead they relied on a summary provided to them by the
Glyphosate Task Force (GTF) . And the GTF consists of Monsanto and a
consortium of chemical companies all over Europe, including Syngenta UK and Dow
Italy, with an odd one from Taiwan thrown in for good measure (see pp. 9-13 of
Vol. 1 of the RAR ). Although the BfR added comments here and there, all
the assessments of the toxicological studies were from the GTF. Hence Monsanto
and other companies who stood to gain from selling glyphosate herbicides were
given free rein to pronounce glyphosate effectively even safer than before,
hence the increase in ADI.
us be clear: even the industry’s studies found toxic effects for acute (single
dose), subchronic (short-term) and chronic (long-term) exposures at some dosage. The way the game is
played is to vary the dose and find the maximum dose where no adverse effects
are observed (NOAL). Then divide that by 100 to obtain the ADI and declare the
substance “safe”. The chemical industries already know that
glyphosate is toxic and can cause a host of physical problems.
rejection of counter-evidence
The GTF used a scheme
devised by H.J. Klimisch and other scientists working for BASF in 1997 to
assess the reliability of toxicological studies . The method aims to
classify toxicological data into one of four categories: reliable without
restriction, reliable with restrictions, not reliable, and not assignable.
However, the assignment is weighted toward industry studies and is heavily
dependent on the judgment of the human toxicologists involved. It can certainly
not overcome human bias.
the rapporteur member state (RMS) has
accepted, without question, virtually all of the unpublished reports given to
them by the chemical companies. Much of the information is blacked out (author,
report title, laboratory) but the sponsoring company is named (Monsanto,
Syngenta etc.) and the reports are referred to by a number.
the industry toxicology reports were in conflict with each other, they chose to
sanction the ones that reported less toxic responses, relegating others to
“supplementary” status. When the toxic effects were significant compared to
their own controls, they used illicit “historical controls” instead to make
them appear less significant.
the published reports, with the exception of genotoxicity, they only used those
that tested for glyphosate alone. The glyphosate was “supplied by Monsanto at
99% purity.” That, despite the fact that the public has been using nothing but
formulations, especially Roundup!
GTF took all of the peer-reviewed studies and proceeded to find excuses to
throw out the ones that didn’t agree with the already-accepted industry
studies. First they threw out all studies that used the actual product
(Roundup, Rodeo, Lasso etc.) because the active ingredient percentage is not
the same from product to product and the surfactants used vary from product to
product so the results cannot be compared and are thus inconclusive. They threw
out any studies where they deemed that the dosage was unreasonably high,
compared to their “safe” levels, although their own toxicology studies showed
the same results at the higher dosages. They threw out any that they decided
were inapplicable to mammals (frog embryos, insect larvae etc.) or that were
administered in a non-natural way (injection). They took issue with how many
rats/mice/dogs/guinea pigs were or were not used and how things were or were
not measured or reported.
human studies, the GTF argued that the dose/response could not be determined;
the toxic effect could not be traced to glyphosate alone, the application rates
were unreasonable for Europe, or there were reporting deficiencies of some
For more details see a
synopsis of the toxicology section of the RAR prepared by Nancy Swanson .
The entire process of risk
assessment for re-approval was flawed and corrupt to the core. It is rife with
conflict of interest, non-transparent and heavily biased towards unpublished,
non-peer reviewed studies from industry. The RAR is worse than useless, and
should be rejected outright. All available evidence
including studies on commercial formulations of glyphosate herbicides should be seriously considered in any
risk assessment, and by a truly independent, unbiased panel free from any conflict
We thank Rosemary Mason for
providing crucial information and discussion in preparing this report.
RAR finalized on BfR website: http://www.bfr.bund.de/en/the_bfr_has_finalised_its_draft_report_for_the_re_evaluation_of_glyphosate-188632.html
Wikibooks, 17 March 2013, http://en.wikibooks.org/wiki/Horticulture/Glyphosate
Parliament bans Roundup, France and Brazil to follow”, The Healthy Home
Economist, 12 April 2014, http://www.thehealthyhomeeconomist.com/roundup-banned-netherlands-france-brazil-likely-soon-follow/
Federal Public Prosecutor Requests Total Ban of Glyphosate Herbicides.
SustainablePulse.com, accessed 26th March 2o14.
Salvador Government Bans Roundup over Deadly Kidney Disease.
Sustainablepulse.com, accessed 27th February 2014
C, Gunatilake S, Senanayake P. Glyphosate, hard water and nephrotoxic metals:
are they the culprits behind the epidemic of chronic kidney disease of unknown
etiology in Sri Lanka? International Journal of Environmental Research and
Public Health 2014, 11, 2125-2147; doi:10.3390/ijerph110202125
E. Sri Lanka partially bans glyphosate for deadly kidney disease epidemic.
Science in Society 62, 18-21, 2014.
“Sri Lanka lifts
ban on sale of glyphosate”, Sustainable Pulse, 13 May 2014, http://sustainablepulse.com/2014/05/13/sri-lanka-lifts-ban-sale-glyphosate/#.U7p8znnjjIU
MW. Glyphosate and Cancer. Science in Society, to appear. 2014
MW. Glyphosate/Roundup and Human Male Infertility. Science in Society, to
11. Ho MW and
Sirinathsinghji E.Ban GMOsNow, ISIS, 2013,http://www.i-sis.org.uk/Ban_GMOs_Now.php
consultation on glyphosate is “entire unfit for purpose””, GM-Free Cymru, 23
May 2014, http://www.gmfreecymru.org/news/Press_Notice23May2014.html
13. Renewal Assessment Report on
glyphosate (2014). Vol. 1. Report & proposed decision, 174 pages. Report
and Proposed Decision. (Summary); Vol. 2 Annex A. List of tests & studies,
251 pages; Vol. 3 Annex B.1. Identity, 12 pages. (Molecular structure and
description); Vol. 3 Annex B.2. Physical & chemical properties, 41 pages;
Vol. 3 Annex B.3. Data on application and further information, 30 pages.
(Application rate, storage & handling); Vol. 3 Annex B.4. Proposals for
the classification and labelling, 3 pages; Vol. 3 Annex B.5. Methods of
analysis, 103 pages. (Analytical methods for determination of active substance,
impurities and residues); Vol. 3 Annex B.6.1. Toxicology and metabolism, 947 pages.
(Animal and human toxicology); Vol. 3 Annex B.7. Residue data. 965 pages. (Crop
residues); Vol. 3 Annex B.8. Environmental fate and behaviour, 361 pages; Vol.
3 Annex B.8 (Appendix). Evaluation of open literature regarding environmental
fate and behaviour, 323 pages; Vol. 3 Annex B.9. Ecotoxicology, 314 pages;
(Non-targeted plants, birds, fish and other creatures); Vol. 3 Annex B.9
(Appendix). Evaluation of peer-reviewed literature on ecotoxicology, 201
pages; List of endpoints, 77 pages; List of information, tests and studies
which are considered as relied upon by the RMS for evaluation, 143 pages. (This document has been taken down from the website after
11 May, but one of us has kept a copy.)
2014 members of
BfR Committee for Pesticides and Their Residues. http://www.bfr.bund.de/en/members_of_bfr_committee_for_pesticides_and_their_residues-189322.html
of BfR Committee for Pesticides and Their Residues. http://www.bfr.bund.de/en/members_of_bfr_committee_for_pesticides_and_their_residues-53534.html
The European Food Safety Authority’s independence problem”, Corporate Europe
Observatory, 23 October 2013, http://corporateeurope.org/efsa/2013/10/unhappy-meal-european-food-safety-authoritys-independence-problem
Parliament demans stricter regulation of conflicts of interest at EU’s food
safety authority”, Corporate Europe Observatory, 3 April 2014, http://www.corporateeurope.org/pressreleases/2014/04/european-parliament-demands-stricter-regulation-conflicts-interest-eus-food
more poisonous than previously assumed, although a critical view should be
taken of certain co-formulants, BfR website: http://www.bfr.bund.de/en/press_information/2014/03/glyphosate__no_more_poisonous_than_previously_assumed__although_a_critical_view
19. Glyphosate facts.
Transparency on safety aspects and use of glyphosate-containing herbicides in
Europe, accessed 7 July 2014, http://www.glyphosate.eu/
Wikipedia, 19 August 2012, http://en.wikipedia.org/wiki/Klimisch_score
Swanson N. Glyphosate
re-assessment in Europe is corrupt, 8 July 2014, https://www.academia.edu/7595699/Glyphosate_re-assessment_in_Europe_is_corrupt_Toxicology
There are 6 comments on this article so far. Add your comment
|Jennifer Symonds Comment left 10th July 2014 15:03:07|
I see money talks in this case rather loudly, it's obvious to anybody (with IQs slightly higher than that of a slug) that risk assessments done by the industry itself is hardly going result in the truth about glyphosates' (& GMOs) dodgy effects being given an airing.
|ian kelly Comment left 10th July 2014 19:07:00|
Ban Monsanto full stop , anything to do with GMO's Keep them BANNED GLOBALLY !!...... Back to little Brown envelopes of the Corrupt .
|Rory Short Comment left 11th July 2014 17:05:20|
To me the people producing this assessment obviously rate life in all its forms as of lesser importance than money and they themselves are life forms, its crazy.
|Todd Millions Comment left 11th July 2014 08:08:17|
Well-at least they haven't(that we know of)tried too make it a vitiamin-Yet.In the family reports from the early 1950's are that a similar level of competence and integrity tried to make aspeostes the equivilent of such in the dying dog days of a gliberal junta via health canaduh."Hits from Quebec,so it must be good for you-no!"So this leaves what to do-Blackmail.It works.
|Alexandre Diaz Odiard Comment left 12th August 2014 00:12:21|
Sigan con la lucha cotra el glifosato y los transgénicos, desde argentina los apoyamos en nuestras luchas todos los 25 de cada mes!!! Follow with the fight against glifosato and transgenics, we support yours fights from the south américa !!!
|Alexander van Dort Comment left 21st January 2015 11:11:36|
Conflicts of interest are obvious. Industry must not evaluate its own products on safety for humans and the soil and water supply. Industry has its own profits calculation.
Monsanto and Bayer and other chemical producing companies must not evaluate their own product-profits where the safety of humans are a factor.