Regulations that disallow human exposure to pesticides that are classified as mutagenic, carcinogenic, reprotoxic (toxic for reproduction), persistent or capable of disrupting endocrine systems within the European Union are under threat.

 These EU regulations are considered the gold standard in public protection by virtue of these and other protective measures.

But industry-linked experts and supporters of anti-regulation pressure groups have ‘taken control’ of the EU’s new Science Advice Mechanism (SAM) process. These experts have contributed to a report commissioned to reevaluate the EU’s authorisation of pesticides.

Public exposure

The report – called “EU authorisation processes of Plant Protection products“, and published in late 2018 – recommends dramatically weakening the EU regulatory system.

The adoption of many ideas previously proposed by the chemical industry is especially notable. 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.

Vytenis Andriukaitis, the EU health commissioner, originally committed the new SAM report. Its purpose was to determine how to act in cases of so-called ‘diverging views’; that is, when media and interest groups get publicly involved.

The request follows a series of major controversies over EU regulatory decision-making. One such controversy was over the herbicide glyphosate (originally marketed by Monsanto as Roundup).

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 UK -opposed a ban.

Ultimately, a very unusual five-year extension for glyphosate was agreed – but soon the discussion will start again.

Major controversies

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”.

This again placed the EU Commission in the crossfire since 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 to address endocrine disruption concerns in the regulations and ban endocrine disrupting pesticides in 2009.

An enormous lobbying effort from industry, the US chamber of commerce, the 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 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 here is also far from over.

Stifling regulation 

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 an event 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 world wide network, a federation of non-profits funded by many industries, including the pesticide industry, and which provides expertise in regulatory issues.

ILSI global includes more than 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 they [ILSI members] generally employ the same lawyers, lobbyists and PR companies, and use essentially the same tactics.”

Behind the scenes

ILSI has 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.

These include 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 seem to disclose their links to ILSI publicly and can therefore appear 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 guidelines 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 Barlow installed an ILSI network in the EFSA working group. This working group then more-or-less copy-pasted the ILSI proposal, making it into an EFSA-opinion. 

Conflicted scientists 

ILSI has been imposing its ideas on many other current EU risk assessment methods too, intending to weaken protections for the public and ease access of pesticides to the market. 

A PAN Europe survey showed that out of 12 EU pesticide risk assessment methods analysed, eight were designed and promoted by ILSI. Industry is being allowed, under the radar, to “write its own rules”.

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.

Boobis has been active in ILSI for decades and, until January 2018, was the chair of its Board of Trustees. Due to his conflicts of interest Boobis left the new expert panels convened by EFSA in 2012.

French professor Dominique Parent-Massin is mentioned alongside Boobis as working on the SAM report. Parent-Massin has previously worked with ILSI-member Aspartame companies including Coca-Cola and 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 and is now part of several ILSI research programs.

All three are listed on the SAM website as contributors to the report, or as providers of evidence through another report written by a new network called Science Advice for Policy by European Academies (SAPEA), or being part of a ‘sounding board’ and fact-checking process. 

Pressure groups

Another expert used by the SAM is German professor Daniel Dietrich, editor-in-chief of the journal Chemico-Biological Interactions. 

He has been very vocal in trying to stop the regulation and banning of endocrine disrupting pesticides (in EU Regulation 1107/2009), along with a group of editors of journals of pharmacology and toxicology. 

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 Stephane Horel who found 17 out of the 18 experts of Dietrich group have past or current ties to industry. 

The Dietrich group has been prolific, publishing articles like ‘Endorcrine disruption: fact of urban legend?’ that disputes the health risks of endocrine disruption.

Anne Glover, an EU science advisor, found that toxicological thresholds below which chemicals are safe were unproven and probably unlikely – achieving a hard won consensus between opposing groups. But Dietrich and his group (along with Boobis) still claimed their opponents used ‘pseudoscience‘.

Dietrich also opposed the EU ban of bee-harming neonicotinoids: both Dietrich and Boobis criticised the IARC report on the genotoxicity of glyphosate.

Industry objectives

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.

The SAM website states that: “The Commission found that none of the interests declared constituted a conflict of interest.”

But one might wonder whether procedures to report conflicts of interest are even functioning. DoIs were not available online when the SAM-report was published in June 2018 and one was 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. Their report 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 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 goal 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.

Hazard approach

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, to 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 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.

These Authors

Hans Muilerman is chemicals coordinator at Pesticide Action Network and is based in Brussels. Dr Jonathan Latham, a former genetic engineer, is executive director of the Bioscience Resource Project and editor of Independent Science News.