APRIL 17, 2019
Current EU regulations forbid
human exposure to pesticides that are classified as mutagenic, carcinogenic,
reprotoxic (toxic for reproduction), persistent or capable of disrupting
endocrine systems. By virtue of these and other protective measures EU regulations
are considered the gold standard in public protection.
However, experts who are
closely linked to industry (or are part of anti-regulation pressure groups)
have taken control of the EU’s new Science Advice Mechanism (SAM). These
experts have contributed to a report commissioned to reevaluate the EU’s
authorisation of pesticides. The report, called “EU
authorisation processes of Plant Protection Products”, and published in
late 2018, recommends dramatically weakening the EU regulatory system.
Especially notable is the adoption of many ideas previously proposed by the
chemical industry. For example, the EU currently deems the acceptable level of
public exposure to mutagenic pesticides (those that damage DNA) to be zero. The
new report recommends scrapping this standard of protection.
The history of the new SAM
report is that it was requested by EU Health Commissioner Vytenis Andriukaitis.
Its purpose was to determine how to act in cases of so-called ‘diverging
views’; that is, when media and public interest groups get involved. The
request follows a series of major controversies over EU regulatory
decision-making. One such controversy was over the herbicide Glyphosate. A
“European Citizens Initiative” delivered more than a million signatures to the
EU Commission asking for a ban on Glyphosate. Several cities banned Glyphosate.
Even a dairy company banned the use of Glyphosate by their
farmers.
With this pressure from all
over Europe, the EU Commission had difficulty reaching a decision since many EU
member states (Bulgaria, Denmark, Czech Republic, Estonia, Ireland, Spain,
Cyprus, Latvia, Lithuania, Hungary, the Netherlands, Poland, Romania, Slovakia,
Finland and the U.K) opposed a ban. Ultimately, a very unusual 5-years
extension for glyphosate was agreed but soon the discussion will start again.
Issues with neonicotinoids
have also pushed the EU Commission into a corner. Neonicotinoid insecticides
are linked by much research to ‘bee colony collapse’ and, according to the
International Union for the Conservation of Nature “represent a worldwide
threat to biodiversity, ecosystems and ecosystem services” (Goulson, 2013; IUCN 2017). This again placed the EU Commission in the crossfiresince many EU member states and their
ministries of agriculture wished to keep neonicotionids on the market. Waves of
scientific publications and media attention about dying bees and empty beehives
forced the EU Commission to finally ban them. Nevertheless, Poland, Romania,
Hungary, and Lithuania still resist the ban by using derogations.
A third big controversy has
been endocrine disruption. Public concern about hormone-mimicking chemicals
forced politicians in 2009 to address endocrine disruption concerns in the
regulations and ban endocrine disrupting pesticides. An enormous lobbying
effort from industry, the US chamber of commerce, EU Directorate General (DG)
Enterprise, and EU DG Growth, tried to stop the implementation of the new
rules, especially during the TTIP trade negotiations with the US. EU DG
Environment was isolated and in the end DG SANTE (health) was found willing to
do the dirty work of undermining
the rules. Again, waves of bad publicity from the public and scientists
harmed the credibility of the EU Commission. This debate too is far from over.
Conflicted science advice
The SAM report is important
since it will soon be used by the EU Commission as an input for its ‘REFIT’
programme to evaluate pesticide regulation. This is a programme that the
chemical industry sees as a major opportunity for a regulatory roll-back.
Some of the experts invited to
help SAM and listed on the SAM website,
however, are not independent. Instead, they have strong links to the
International Life Sciences Institute (ILSI). ILSI is a worldwide network, a
federation of non-profits funded by many industries, including the pesticide
industry, and which provides expertise in regulatory issues.
ILSI global includes over 400
company members and ILSI
Europe includes 88. Among them are every pesticide multinational.
Sourcewatch writes of ILSI that: “The interests of
food, pharmaceutical, tobacco, energy, and other industries have become even
more entwined. They have learned to cooperate (rather than blaming each other
for the cancer epidemic) and they now form coalitions to fight health and
environmental regulations.
“It is notable that [ILSI
members] generally employ the same lawyers, lobbyists and PR companies, and use
essentially the same tactics”.
ILSI has a negligible public
profile, and claims not to be a lobby group, but is very active behind the scenes in obtaining seats for
ILSI-associated scientists on regulatory panels such as that of the EU Food
Safety Authority (EFSA) and international organisations like WHO, the World
Health Organisation, the Food and Agriculture Organisation (FAO) of the UN, and
the International Programme on Chemical Safety (IPCS) of the WHO. Experts
generally do not disclose their links to ILSI and pretend to be independent
academic scientists.
A recent example of ILSI
members successfully getting seats on an EFSA-panel concerned the risk
assessment idea of a Threshold of Toxicological Concern (TTC). This idea
assumes chemicals are safe at low doses without (expensive) testing. It has
been an important goal of the chemical industry to establish TTCs in European
and other jurisdictions.
PAN Europe has analysed the process of developing guideline for
the TTC at the European Food safety Authority EFSA. We discovered that the
chair of the EFSA working group was Sue Barlow, who worked for ILSI and the
cigarette industry. She had volunteered to be chair of the EFSA working group.
From this position she installed an ILSI network. This EFSA working group then
more-or-less copy-pasted the ILSI proposal, making it into an EFSA opinion.
ILSI has been imposing its
ideas on many other current EU risk assessment methods too, intending to weaken
protections and ease access of pesticides to the market. Thus a PAN Europe
survey showed that out of 12 EU pesticide risk assessment methods analysed, 8
were designed and promoted by ILSI. Industry is being allowed,
under the radar, to “write its own rules”.
The conflicted scientists
In the case of the SAM, a
prime example of these conflicts is UK professor Alan Boobis who is listed on
the SAM website as a contributor to the SAM report. Alan Boobis has been active
in ILSI for decades. Until January 2018 he was the chair of its
Board of Trustees. Due to his conflicts of interest Boobis was disbarred from a new expert panel convened
by EFSA in 2012.
French professor Dominique
Parent-Massin is mentioned alongside Boobis as working on the SAM report. Prof.
Parent-Massin has previously worked with ILSI member, Ajinomoto – the
world’s biggest Aspartame producer.
Also listed on the SAM website
is Joergen Schlundt, former Director of the Danish National Food Institute.
Schlundt is also a former ILSI board member.
All three are listed on the
SAM-website as contributors to the report, or as providers of evidence through
another reportwritten by a new network called Science Advice for
Policy by European Academies (SAPEA), or as being part of a ‘sounding board’
and fact-checking process. Despite these counter-indications the SAM
website states that “The Commission found that none of the
interests declared constituted a conflict of interest.”
Another expert used by the SAM
is German professor Daniel Dietrich, editor-in-chief of the journal Chemico-Biological Interactions. With a group of editors of
journals of pharmacology and toxicology he has been very vocal in trying to
stop the regulation and banning of endocrine disrupting pesticides (in EU
Regulation 1107/2009). Dietrich published editorials in several scientific journals that
triggered highly critical responses from other scientists, such
as members of the ‘Endocrine Society’. Ties between the Dietrich group of
authors and industry were exposed by Le Monde journalist Stéphane Horel who
found 17 out of the 18 experts of Mr. Dietrich’s group have past or current
ties to industry. The Dietrich group has been prolific, publishing articles
like ‘Endocrine disruption: Fact or urban legend?’ that disputes the health
risks of endocrine disruption (Nohynek et al., 2013). Even after former EU science advisor
Anne Glover achieved a consensus between opposing groups that toxicological
thresholds below which chemicals are safe (see TTC above) were unproven,
Dietrich and his group (along with Alan Boobis) still claimed their opponents
used “pseudoscience” (Dietrich et al., 2016). Dietrich also opposed the EU ban of bee-harming neonicotinoids, and
both Dietrich and Boobis criticized the IARC-report asserting the genotoxicity of Glyphosate.
Conflicts in EU science advice
The EU has mechanisms to
prevent conflicts of interest from derailing its scientific decisions. The SAM
website currently presents‘Declarations of Interest’ (DoI) for its
members including for Boobis, Parent-Massin, Dietrich, and Schlundt. But one
might wonder if procedures to report conflicts of interest are functioning.
DoI’s were not available online when the SAM-report was published (in June
2018). One was even not signed until considerably after publication, in August
2018.
The efforts of ILSI have so
far been effective. Several of its campaigning targets are included in an
important “SAPEA evidence review report“. SAPEA (Science Advice for
Policy by European Academies) is a new body set up by European science
academies. This evidence review is intended to feed into the SAM report and
featured many of the conflicted scientists above. SAPEA’s report promotes many
industry objectives, such as the use of ‘historical control data’. The great
importance of this is that, since many potential historical controls exist,
their use makes it much easier to ascribe toxic effects observed in animal
testing as being simply noise and therefore irrelevant.
Another industry goal is to promote
inexpensive (in vitro) ‘mode-of-action assessment’ in preference to expensive adverse
outcome testing. A third is to drop the obligation for chronic mouse testing.
The aims of PAN Europe and the
Endocrine Society, on the other hand, are: 1) to recognise the reality of ‘low
dose effects’ which are currently not tested at all for pesticides; 2) the
recognition that chemicals may cause non-linear toxicity responses over a wide
range of doses. These are called ‘non-monotonic dose-effect responses’ (whereas
regulators presently acknowledge only linear dose-response curves of toxicity
and even dismiss effects entirely if they are not linear); 3) mandatory testing
for endocrine disruption; 4) to dispute the current regulatory assumption that
chemicals have safe thresholds. All are missing from the SAPEA report.
In a further blow to
precaution, the SAM report proposes to change EU rules by exchanging the
acceptable level of citizen protection from “do not have any harmful effects on
humans” for an undefined level, that of “acceptable risk”. This is the change
of regulation that would make human harm legal, since it would stop the EU’s
much-detested-by-industry ‘hazard approach’ that aims to avoid any exposure of humans
to classified (mutagenic, carcinogenic, reprotoxic (toxic for reproduction),
persistent and endocrine disrupting) pesticides.
SAM proposes that the EU
should re-examine this ‘hazard approach’, which has been under
attack by industry for many years; and so it seems that SAM might
prove to be the instrument by which industry finally achieves successes for
which they have campaigned so long.
The EU has shown itself
sensitive to public pressure. What is now needed is for that pressure to be
redoubled.
Hans Muilerman works
at PAN Europe and
is based in Brussels.
Jonathan Latham edits
Independent Science News, where this article first appeared.
References
Goulson, D. (2013) An overview of the environmental risks posed by neonicotinoid
insecticides. Journal of Applied Ecology 50: 977–987.
Nohynek, G.J., C. J. Borgert,
D. Dietrich, and K. K. Rozmand (2013) Endocrine disruption: Fact or urban legend?, Toxicology
Letters 223 295– 305.
Dietrich et al., (2016) 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 (2016) 1-3.
Dietrich et al., (2013) Open
letter to the European commission: scientifically unfounded precaution drives
European commission’s recommendations on EDC regulation, while defying common
sense, well‑established science, and risk assessment principles. Arch Toxicol
(2013) 87:1739–1741.
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