Documents seen by Reuters show how a draft of a key section of the
International Agency for Research on Cancer's (IARC) assessment of
glyphosate - a report that has prompted international disputes and
multi-million-dollar lawsuits - underwent significant changes and
deletions before the report was finalised and made public.
IARC, based in Lyon, France, wields huge influence as a
semi-autonomous unit of the WHO, the United Nations health agency.
It issued a report on its assessment of glyphosate - a key
ingredient in Monsanto Corp's top-selling weedkiller RoundUp - in
March 2015. It ranked glyphosate a Group 2a carcinogen, a substance
that probably causes cancer in people.
That conclusion was based on its experts' view that there was
"sufficient evidence" glyphosate causes cancer in animals and
"limited evidence" it can do so in humans. The Group 2a
classification has prompted mass litigation in the United States
against Monsanto and could lead to a ban on glyphosate sales across
the European Union from the start of next year.

The edits identified by Reuters occurred in the chapter of IARC's
review focusing on animal studies. This chapter was important in
IARC's assessment of glyphosate, since it was in animal studies that
IARC decided there was "sufficient" evidence of carcinogenicity.
One effect of the changes to the draft, reviewed by Reuters in a
comparison with the published report, was the removal of multiple
scientists' conclusions that their studies had found no link between
glyphosate and cancer in laboratory animals.
In one instance, a fresh statistical analysis was inserted -
effectively reversing the original finding of a study being reviewed
by IARC.
In another, a sentence in the draft referenced a pathology report
ordered by experts at the U.S. Environmental Protection Agency. It
noted the report "firmly" and "unanimously" agreed that the
"compound" – glyphosate – had not caused abnormal growths in the
mice being studied. In the final published IARC monograph, this
sentence had been deleted.
Reuters found 10 significant changes that were made between the
draft chapter on animal studies and the published version of IARC's
glyphosate assessment. In each case, a negative conclusion about
glyphosate leading to tumors was either deleted or replaced with a
neutral or positive one. Reuters was unable to determine who made
the changes.
IARC did not respond to questions about the alterations. It said the
draft was "confidential" and "deliberative in nature." After Reuters
asked about the changes, the agency posted a statement on its
website advising the scientists who participate in its working
groups "not to feel pressured to discuss their deliberations"
outside the confines of IARC.
Reuters contacted 16 scientists who served in the IARC expert
working group that conducted the weedkiller review to ask them about
the edits and deletions. Most did not respond; five said they could
not answer questions about the draft; none was willing or able to
say who made the changes, or why or when they were made.

The chairman of the IARC sub-group tasked with reviewing evidence of
glyphosate's effect on laboratory animals was Charles Jameson, an
American toxicologist. In testimony as part of personal-injury
lawsuits against Monsanto in the United States, Jameson told lawyers
for Monsanto he did not know when, why or by whom the edits had been
made.
Monsanto is facing multiple legal claims in the U.S. from plaintiffs
who allege glyphosate gave them or their loved ones cancer. Jameson
is an expert witness for the plaintiffs. He did not respond to
questions for this article.
Scott Partridge, Monsanto's vice president of global strategy, told
Reuters the changes to the draft showed how "IARC members
manipulated and distorted scientific data" in their glyphosate
assessment.
IARC declined to comment.
Numerous national and international agencies have reviewed
glyphosate. IARC is the only one to have declared the substance a
probable carcinogen. Compared with other agencies, IARC has divulged
little about its review process. Until now, it has been nearly
impossible to see details, such as draft documents, of how IARC
arrived at its decision.
The European Food Safety Authority (EFSA) said that in its
assessment of the weedkiller, the scientific decision-making process
"can be traced from start to finish." Jose Tarazona, head of EFSA's
pesticides unit, told Reuters: "Anyone can go to EFSA's website and
review how the assessment evolved over time. So you can see clearly
how experts … appraised each and every study and also how comments
from the public consultation were incorporated into the scientific
thinking."

In the United States, the Environmental Protection Agency published
a full 1,261-page transcript of a three-day scientific advisory
panel meeting on its ongoing evaluation of the carcinogenic
potential of glyphosate in December 2016.
No such record of the deliberations behind IARC's monographs is
published.
In a previous response to questions about the transparency of the
IARC process, the agency's director, Chris Wild, referred Reuters to
a letter in which he said his agency's assessments are "widely
respected for their scientific rigor, standardized and transparent
process." Wild also said IARC's methods are intended to allow
scientists to engage in free scientific debate at its monograph
meetings.
DELETIONS AND ADDITIONS
IARC says its working group scientists are selected for "their
expertise and the absence of real or apparent conflicts of
interest." For the panel that evaluated glyphosate and four other
pesticides in what is known as IARC's Monograph 112, scientists from
11 countries met at the agency's headquarters in Lyon for a
week-long meeting starting on March 3, 2015. The meeting "followed
nearly a year of review and preparation" by IARC staff and working
group members, "including a comprehensive review of the latest
available scientific evidence," IARC said in a statement at the
time.
In June, Reuters reported how the chairman of the IARC working group
was aware of new data showing no link between glyphosate and cancer
in humans, but the agency did not take it into account because it
had not been published.
No drafts of IARC's glyphosate assessment have surfaced before.
However, a draft was obtained by Monsanto as part of the legal
proceedings in the United States. Reuters reviewed chapter 3, the
section on animal studies, which is the only section no longer
covered by a confidentiality order of the court.

The glyphosate review in IARC's Monograph 112 runs to 92 pages; the
chapter on animal studies consists of just over 10 pages. Reuters
has not seen any other sections of the draft and cannot say whether
they also underwent significant edits.
[to top of second column] |

In comparing draft and final versions of chapter 3, Reuters found
that in several instances comments in the draft were removed; the
comments noted that studies had concluded glyphosate was not
carcinogenic. They were replaced in the final version with the
sentence: "The Working Group was not able to evaluate this study
because of the limited experimental data provided in the review
article and supplemental information."
This sentence was inserted six times into the final version. Each
time it replaced a contrary conclusion, noted in the draft, by the
original investigators on the study being considered, such as: "The
authors concluded that glyphosate was not carcinogenic in Sprague
Dawley rats"; "The authors concluded that glyphosate technical acid
was not carcinogenic in Wistar rats"; and "The authors concluded
that glyphosate was not carcinogenic in CD-1 mice in this study."
Reuters also found changes to the conclusions and statistical
significance of two mouse studies. These studies were cited in
IARC's ultimate finding of "sufficient" evidence that glyphosate
causes cancer in animals.
One edit concerned a 1983 study in mice. IARC's published monograph
contains a fresh statistical analysis calculation as part of its
review of that study. The original investigators found no
statistically significant link between glyphosate and cancer in the
mice. IARC's new calculation reached the opposite conclusion,
attributing statistical significance to it.
This new calculation was inserted into the final published
assessment, but was not in the draft version seen by Reuters. The
change gave the working group more evidence on which to base its
conclusion that glyphosate was probably carcinogenic.

In further discussion of the same 1983 study, IARC's final published
report refers to expert pathologists on a panel commissioned to
reanalyze the work of the original investigators. The IARC draft
notes that these pathologists "unanimously" agreed with the original
investigators that glyphosate was not related to potentially
precancerous tissue growths in the mice. IARC's final report deletes
that sentence.
Reviewing a second mouse study, the IARC draft included a comment
saying the incidence of a type of animal cancer known as
haemangiosarcoma was "not significant" in both males and females.
IARC's published monograph, by contrast, inserts a fresh statistical
analysis calculation on the data in male mice, and concludes that
the findings were statistically significant.
INFLUENTIAL MONOGRAPH
IARC's assessment that glyphosate is a probable human carcinogen is
an outlier. In the 40 or so years since the weedkiller first came to
the market, glyphosate has been repeatedly scrutinized and judged
safe to use.
A year after IARC issued its evaluation, a joint United Nations and
World Health Organization panel reviewed the potential for
glyphosate in food to cause cancer in people. It concluded the
weedkiller was "unlikely to pose a carcinogenic risk to humans."
The U.S. Environmental Protection Agency, which first assessed
glyphosate in the 1980s and has reviewed it several times since,
says it has "low toxicity for humans." The European Food Safety
Authority and the European Chemicals Agency, which advise the 28
members of the EU, have also assessed glyphosate within the past two
years and ruled it safe.
But IARC's Monograph 112 has had great influence.

It is weighing heavily on a pending European Union decision – due by
the end of the year and possibly to be made next week - on whether
glyphosate should be relicensed for sale across the 28 member
states. France, one of the bloc's agricultural powerhouses, has said
it wants the weedkiller phased out and then banned, provoking
protests by its vocal farmers, who argue glyphosate is vital to
their business.
A failure to renew glyphosate's license by the end of the year would
see an EU ban kick in on Jan. 1, 2018.
In the United States, Monsanto – the firm that first developed and
marketed glyphosate - is facing litigation in California involving
at least 184 individual plaintiffs who cite the IARC assessment and
claim exposure to RoundUp gave them a form of cancer known as
non-Hodgkin lymphoma. They allege Monsanto failed to warn consumers
of the risks. Monsanto denies the allegations. The case is ongoing.
Members of the U.S. Congress, concerned about what they described as
IARC's "inconsistent" standards and determinations for classifying
substances as carcinogenic, last year launched investigations into
American taxpayer funding of IARC. The investigations are ongoing.
In Europe, IARC has become embroiled in a public spat with experts
at the European Food Safety Authority, which conducted its own
review of glyphosate in November 2015 and found it "unlikely to pose
a carcinogenic hazard to humans."
With IARC monograph meetings, some outside observers are selected
and allowed to witness proceedings, but they are banned from talking
about what goes on. Journalists are generally not allowed in.
Last year, Reuters reported on an email sent by IARC to the experts
on its glyphosate working group in which the agency advised them not
to discuss their work or disclose documents. The email said IARC
"does not encourage participants to retain working drafts or
documents after the monograph has been published."

Reuters sent questions about the draft version of the glyphosate
assessment to members of the IARC working group that assessed the
herbicide as well as to the head of IARC's monograph program, Kurt
Straif, and to Kathryn (Kate) Guyton, the staffer responsible for
the glyphosate review. IARC responded by posting the following
message on its website:
"Members of the IARC Monograph Working Group which evaluated
glyphosate in March 2015 have expressed concern after being
approached by various parties asking them to justify scientific
positions in draft documents produced during the Monographs process.
IARC would like to reiterate that draft versions of the Monographs
are deliberative in nature and confidential. Scientists should not
feel pressured to discuss their deliberations outside this
particular forum."
IARC answered none of Reuters' specific questions about changes to
the draft.
(By Kate Kelland. Editing By Richard Woods)
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