Endocrine Disruptors

Both the Greens and the Socialists have said they oppose the criteria in their current form. If a majority of MEPs does the same in the Parliament vote, the Commission has to go back to the drawing board. But MEPs have become the target of a last-minute lobby attempt by industry and industry-linked scientists repeating old arguments and blatantly going against the current state of science on endocrine disruption.

The agreed criteria are based on a proposal by the European Commission’s Directorate General for Health and Food Safety (DG SANTE), despite the strong warning that was issued ahead of the July vote by three highly respected international scientific societies of endocrinology (the Endocrine Society, the European Society of Endocrinology and the European Society for Paediatric Endocrinology). They warned Member States not to accept the DG SANTE proposal, concerned that “the criteria will not be effective in protecting public health”.

Endocrine disrupting chemicals (EDCs) are chemicals that are present in a number of everyday products – from plastics and cosmetics to pesticides. Because of their ability to interact with the hormonal (endocrine) systems of living organisms even at very low doses, they have serious detrimental effects on human and environmental health. They are linked to several serious health conditions, including hormone-related cancers, obesity, and damage to reproductive systems. The EU’s chemicals and pesticides Regulations stipulate that endocrine disruptors should be banned – a fact that has not been sitting well with the chemical industry.

Throughout the resulting lobby battle, the chemical industry has lost many of its key arguments. But thanks to a large-scale lobbying campaign and some assistance from within the Commission, industry has still managed to delay and weaken the very first step in the process of EDC regulation: the establishment of scientific criteria to identify those chemicals that are of concern.

The proposed criteria contain critical flaws which would allow many chemicals to remain unaffected by a ban, since the required burden of evidence is too high to be feasible, and there is no process in place to obtain the additional evidence needed. Absurdly, the criteria also exclude substances from being identified as endocrine disruptors if they have been specifically designed as such! This would, for instance, exclude pesticides from a ban which are engineered to kill organisms by interfering with their hormone system.

Let’s briefly revisit some of the most mind-boggling in a long series of scandals, that could end up rendering a key piece of public health regulation largely ineffective.
 

1. DG Environment vs DG SANCO/SANTE and a prefabricated EFSA opinion

The European Commission’s DG Environment was initially in charge of developing scientific criteria for endocrine disruptors. However, before they could publish their proposal, which was based on the so-called ‘Kortenkamp report’ issued by some of the most respected experts in the field of endocrinology, the Commission’s department responsible for health policy (DG SANCO, now called DG SANTE) interfered, requesting an opinion on the issue by the European Food Safety Authority (EFSA).

EFSA went to work in October 2012 by forming a working group, which in March 2013 published the agency’s opinion: “[Endocrine disruptors] can [...] be treated like most other substances of concern for human health and the environment.” A message which has since been forever echoed by pesticide industry lobby group the European Crop Protection Association (ECPA).

Just two months later, journalist Stéphane Horel’s research appeared in LeMonde, revealing that 8 out of 18 members of the EFSA working group on endocrine disruptors had conflicts of interest with the affected industry. Three of them had ties with industry lobby group the International Life Sciences Institute (ILSI), one with chemical industry lobby group CEFIC, another one with Syngenta.

In the meantime, the World Health Organisation published a joint report with the UN Environment Programme (UNEP), calling for urgent action on endocrine disruptors. Internal emails from the aforementioned working group at EFSA (see A Toxic Affair, p.10) highlights the group’s clear awareness that their input on the issue would put them “in isolation with the rest of the world” as far as scientific assessments are concerned.

One member of the group wrote:

“I am happy I don’t need to be at the press conference and stakeholder meeting (as planned the 20 March) and present and defend the current EFSA [Scientific Committee] report, knowing that the audience have read the WHO-UNEP report. A straightforward killer situation!”

In December 2016, Le Monde investigations showed that the EFSA conclusion was prefabricated. Their central conclusion had already been included in an email from EFSA to the working group even before the group had begun its work. By the time this was revealed, the new Juncker Commission had taken DG Environment off the job, and put the responsibility in the hands of DG SANTE.

2. Industry-linked scientists derail DG Environment’s proposal

Before the responsibility for proposing draft criteria for the identification of EDCs was moved from DG Environment to DG SANTE, industry had found itself unable to influence the Commission’s work and twist the criteria in a way that would protect its products from a ban. Just before DG Environment was about to publish its proposal, an extraordinary letter was sent by a group of scientists to then-Chief Scientic Adviser of Commission President Barroso, Anne Glover, criticising EU plans to regulate endocrine-disrupting chemicals.

Ms Glover, in turn, sent a note of alarm to the Commission’s Secretary-General Catherine Day. Ms Day then used the scientists’ letter as an excuse to impose an impact assessment on the yet unpublished DG Environment proposal, as demanded repeatedly by industry. This was the first step that would pave the way for the derailing of EU action on endocrine disruptors.

In a nutshell: Even before scientific criteria to identify endocrine disruptors were established, they were already subject to an assessment of their potential impact on industry interests! This caused several years of delay in the regulatory process, meaning the European Commission failed to meet the deadline for draft criteria set out by law - December 2013.

It was later revealed by an Environmental Health News investigation that 17 of the 18 scientists who wrote to Anne Glover, all of them editors of toxicology journals, “had ties to the chemical, pharmaceutical, cosmetic, tobacco, pesticide or biotechnology industries”, and that “some have received research funds from industry associations, while some have served as industry consultants or advisors.”

The scientific community consequently condemned the interference of this group of pro-industry colleagues in the regulatory process in two statements. “The letter by Dietrich et al does the European Commission, science – including the field of toxicology – and most importantly, public health – a profound disservice”, they wrote in the journal Endocrinology.

3. Back and forth: industry-linked scientists sustain ‘scientific constroversy’

After delaying EU action on endocrine disruptors via the letter that gave rise to the impact assessment, the industry-linked scientists continued to create an illusion of ‘scientific controversy’ among the wider scientific community, even though Anne Glover facilitated two meetings in order to establish a consensus on key issues.

Both the Berlin and the Brussels meeting of the ‘two camps’ of scientists were facilitated by Anne Glover herself, with surprising results. At each meeting , the industry-linked scientists agreed to things they previously opposed: that it might be impossible to set safety thresholds for endocrine disruptors, and that the ‘potency’ of a substance should not be part of the criteria to identify them.

Yet, after each meeting the industry-linked scientists would return to the media with the same, unaltered messages from their original letter, attacking other endocrine scientists. Shortly after the second meeting in May 2016, the group, which now calls itself the ‘Concerned Toxicologists for Better Science and Regulation’ had a meeting with Commissioner Andriukaitis.

Given the occasion, the group published a press release not very subtly titled “Well-known Scientists Ready to Stem the Onslaught of Pseudoscience in the EU”, in which they once again took on the ‘other camp’ of scientists, claiming, as they had also communicated to EU Health and Food Safety Commissioner Andriukaitis, that “the presentation of the issue of EDCs to the public and to the Commission by some scientists has been deliberately selective and has proposed courses of action that […] are not supported by a robust scientific evidence base”.

Importantly, Le Monde revealed that the group’s expenses for its meeting with Commissioner Andriukaitis had been coveredby the European Risk Forum, Brussels-based industry think tank created by the tobacco industry in the 1990s to fight the tobacco bans in public places. In 2016, the ERF was funded by 18 membres, all of them industry players: lobby groups representing the chemicals, plastics, pesticides and toy industries in Brussels (CEFIC, PlasticsEurope, ECPA, Toy Industries of Europe), the nickel industry (Nickel Institute, Norilsk Nickel Europe) and individual companies such as BASF, Bayer, Dow, Syngenta, IFAH-Europe (veterinary medecines), British American Tobacco, and Philip Morris International.

The Glyphosate Connection

Interestingly, among the small group of industry-linked scientists that vocally interfered in the regulation of endocrine disrupting chemicals, three are also prominently involved in the glyphosate debate: Helmut Greim, Colin Berry and Alan Boobis. Both Helmut Greim and Colin Berry are among the authors of the so-called ‘Intertek Papers’, which were paid for by Monsanto and are serving to attack the assessment of glyphosate as “likely to cause cancer in humans” by the World Health Organisation’s cancer agency IARC.

Eighty-two year old Helmut Greim is known for having defended industry’s interest on multiple occasions in his career, from PCBs (polychlorinated biphenyl, a very harmful industrial chemical) to Dieselgate. Colin Berry has worked as a consultant for agrochemical producers such as Syngenta and Monsanto, and his name has appeared in the Monsanto Papers. He also served on an advisory council for  by the European Risk Forum titled “Scientific Evidence and the Management of Risk”.

Alan Boobis is the vice-president of the International Life Sciences Institute (ILSI Europe), the European branch of one of the largest food industry lobby groups in the world, which is funded by corporations such as Monsanto, BASF, Coca-Cola, Kraft and McDonald’s. His name was the first to appear on a conclusion on glyphosate published by the Joint Meeting on Pesticides Residue (JMPR), a joint body between the UN’s World Health Organisation and its Food and Agriculture Organisation, two days before a crucial meeting of EU States. The conclusion stated that “glyphosate is unlikely to pose a carcinogenic risk to humans from exposure through the diet”. For industry, this was a most timely and highly convenient message, even though the JMPR assessment was not actually relevant to the question of whether or not glyphosate is carcinogenic and was quite limited in scope, as it neglected non-dietary exposure channels, such as occupational or by-stander exposure.

And what about the impact assessment that had been ordered by the Commission’s Secretary-General Catherine Day?

The opinion of the Regulatory Scrutiny Board, an independent body of the Commission scrutinising all draft impact assessments for existing legislation, pointed out to DG SANTE that

the scientific criteria for the identification of endocrine disruptors should be specified “only on the basis of the relevant scientific evidence and irrespective of the economic and social impacts” of any given policy option. They also criticised “the current methodological bias of the proposed multi-criteria analysis favouring options banning fewer substances”.

4. TTIP manouvres

The TTIP negotiations have been a major source of pressure against the EU taking action on endocrine disruptors. For instance, in March 2013, the US and EU pesticide lobby groups Croplife America and ECPA paid a joint visit to the Commission’s Secretary General to talk about the way the EU would deal with endocrine disruptors and how that seemed contrary to the goals of TTIP. Croplife America’s position was that the US should take action at the WTO “if the EU pursues its proposed new regulatory regime for endocrine disruptors without an approach based on risk assessment”. (Toxic Affair p.14).

Three years later, mid-June 2016, the Commission had finally presented a proposal for criteria to identify endocrine disruptors. It was strongly criticised, among others by the Endocrine Society: the Commission criteria require “a level of certainty that are nearly unachievable scientifically”.

One month later on 13 July 2016 Health Commissioner Andriukaitis received a visit from the ambassadors of the United States, Canada, Brazil, Uruguay and Argentina, specifically to address the issue of EU regulation of endocrine disruptors and the impacts on international trade... The minutes of this meeting, obtained by Oneworld.nl, show how the US ambassador opened the meeting by “expressing concern of countries on proposals submitted by COM [the Commission, red] on criteria for ED [endocrine disruptors, red], in particular their impact on import tolerances”.

The Commission then responded: “COM proposal foresees possibility to establish MRLs [maximum residue levels, red], which should be accepted as an ambitious proposal to address the concerns expressed by the Ambassadors”.

5. DG SANTE power abuses: from “negligible risk” to “intended EDCs are not EDCs”

By December 2016, the Commission had gone one step further, getting ready to create a major loophole in EU pesticide regulation by extending the grounds for exceptions, so-called ‘derogation’, from from “negligible exposure” to “negligible risk”. The pesticide law states that an exception is only allowed if human exposure to a given substance can be considered “negligible”.

As explained by Stéphane Horel in Le Monde, this means that it would have been “sufficient to assess the risk that [substances] present on a case-by-case basis if problems arise after they have been placed on the market”.

The Commission justified its move by pointing to an article in the pesticide law that allows adjustments “according to scientific advances”. The Commission further referred to the aforementioned pre-fabricated EFSA conclusion as a basis.

This proved very controversial among Member States and at the European Parliament. It was considered an ‘abuse of power’ by the Commission, because it was seeking toactually change the meaning of the law, not just implementing it. Facing certain failure, the Commission eventually took this loophole out of the proposal.

Only to introduce another one, which still features in the current proposal to be voted on by MEPs: This time around, the loophole excludes chemicals from identification as endocrine disruptors when they have specifically been designed as such. Environmental law organisations CIEL and ClientEarth concluded that by including this loophole, the “European Commission went beyond its power, voiding the decision of the EU Parliament and Council to ban dangerous endocrine disrupting chemicals from being used in pesticides”. The organisations called the proposal to exempt these endocrine disruptors an “unlawful gift to the pesticide industry that sacrifices public health”.

CIEL also pointed out that “because these criteria are narrowly designed for application within the Biocide and Pesticide regulations to the exclusion of all other areas where EDCs exist, the criteria cannot be used in the context of the cosmetics, food packaging, children’s toys, and medical devices regulation, thereby guaranteeing continued [human] exposure [to endocrine disruptors] from these products.”

6. Last minute lobbying in the European Parliament: back to potency and scaremongering about crop losses (“Low Yield Legislation”)

In a last minute attempt to sway tomorrow’s vote in the EP Environment Committee in favour of industry, the European Crop Protection Association (ECPA) has been distributing ’fact sheets’ to MEPs. Disregarding all scientific consensus on the issue, the hand-outs repeat the old mantra that insists, “[i]t’s the Dose that makes the Poison”, meaning the potency factor has to be taken into account in any identification of endocrine disruptors. ECPA’s note concludes that “[t]here is little risk from these substances at the normal doses we consume”.

On top of this, the pesticide lobby group adds a generous helping of economic scaremongering by framing EU action on endocrine disruptors as “Low Yield Legislation” and arguing that rapeseed, potatoes and sugar beets could suffer losses of up to 31%, and that Italy’s tomato harvest could drop by 25%, while Poland’s apple harvest would halve, and agricultural imports into the EU would quadruple – all to the detriment of European farmers.

Two days before the vote in the European Parliament Environment Committee, Conservative MEP Cristian Busoi hosted a panel event on endocrine disruptors. The speakers included three members of the group of industry-linked scientists that triggered the impact assessment, among them Helmut Greim and Daniel Dietrich. Only one speaker was invited to represent the three scientific societies that had warned against DG SANTE’s weak proposal, but other well known endocrine experts like Barbara Demeneix of the National Museum of Natural History and Leonardo Trasande of New York University were in the room.

Helmut Greim once again echoed industry’s messages: “The dose makes the poison. Therefore potency has to be included. There is no epidemiological evidence for serious hazards from endocrine disruptors”. Greim quoted EFSA’s infamous conclusion that EDCs “can be treated like most other substances of concern”.

Going against everything that had been agreed in the consensus meetings hosted by Anne Glover, Daniel Dietrich added: “Endocrine disruptors are not active at very low doses […] there is nearly always a threshold”. He went as far as to liken the consumption of products like alcohol and mustard to the involuntary exposure to chemicals concerning, for instance, a foetus in the womb.

Gisela Degen, the third of the group said to be surprised by the critique of the scientists from the Endocrine Society, and that the Commission’s criteria were “more or less what we agreed”, a claim met by vocal disagreement by the concerned scientists in the room.

Conservative MEP Grossetete said the criteria were not perfect but good enough, and that no further delay was acceptable, since EU citizens are expecting a solution now. She accused Member States of creating more delay, when in fact it was the Commission who ordered an unjustified impact assessment and thereby caused a much longer delay than the discsussions with Member States did.

Klaus Berend of DG SANTE claimed once more that the EC proposal is a “reasonable compromise between widely differing views, as you have just heard between Nadal and Dietrich”. Apparently, the Commission is once more making the grave mistake of comparing the input by a group of largely industry-linked scientists to that by three large, widely-recognised scientific societies.

This kind of misleading ‘middle-ground brokering’ cannot be justified, and would betray the very essence of science-based regulation. MEPs must take a stand in tomorrow’s vote and reject DG SANTE’s criteria for the identification of endocrine disruptors, that would fail to protect public health from the chemicals harmful effects on the human hormone system.