Can the Benefits of Using Agricultural Chemicals Outweigh the Risks?
Sadly, I was not able to attend the European Parliamentary Workshop on glyphosate organised by Pavel Poc, Member of the European Parliament, EuCheMS and ECTN on 10th May, 2017, but I have watched the video and was impressed by the very high level of scientific debate with most, but sadly not all, approaching the discussion with an open mind. It was appropriate that this debate focussed mainly on the science but it got me thinking about the whole issue of hazard/risk and risk versus benefit.
More generally, can it ever be justifiable to use a hazardous chemical? Of course, if the risk can be contained to an acceptably low level. Petrol (gasoline) is a very hazardous material because it forms highly explosive mixtures with air, which is why it works as a fuel. Yet, all of us are happy to drive around with many litres of it in the back of our cars. It is contained in such a way that the risk of an uncontrolled explosion is very slight, but it is not zero. Sometimes, there are accidents and massive explosions that take lives. In this case, the hazard can be controlled and the risk minimised to such an extent that we accept that the benefits far outweigh the risks.
Similarly with glyphosate. If, and the jury is still out, there is a higher risk of contracting lymphomas amongst those who apply glyphosate, and this risk can be controlled by the use of suitable protective clothing, then the benefits in terms of food yield, cost, quality and nutrient use may very much outweigh the risks. If, and again evidence is not there for humans, very low levels of glyphosate lead, for example, to very much increased incidences of non-alcohol based liver damage, the situation is quite different.
There are some people who would argue that the use of all manmade chemicals in agriculture should be banned. Currently, we produce about as much food as we need to feed the 7 billion people in the world. In some places, we eat too much and waste food in others there is too little. It is estimated that crop yields are increased by around 25 – 40 % by using agricultural chemicals. So, if we ban them, 1/5 of the world’s population will starve. Do we really want that to happen? Organic farming cannot solve this problem without human sewage being recycled onto the earth. Unless this is done, there is a one-way stream of nutrients (mainly phosphorus and nitrogen, but also trace elements) from the soil through plants, animals and humans into the sea or sewage deposits, thus depleting the soil. Nitrogen can be replaced by growing leguminous crops, but one of the few companies in Europe trying to extract and recycle phosphorus from sewage failed.
we should certainly continue to test (and sometimes withdraw) chemicals used in agriculture, reduce the amounts used to the minimum effective dose, improve application methods and protect workers
Every death by whatever cause is regrettable and should be avoided. Hence, we should certainly continue to test (and sometimes withdraw) chemicals used in agriculture, reduce the amounts used to the minimum effective dose, improve application methods and protect workers. Ideally there would be no deaths associated with the use of agricultural chemicals, but if banning them will cause the deaths of 1-2 billion people, how many people would we be prepared to see die in their manufacture, application and as a result of the ingestion of their residues if we continue to use them? When do their benefits exceed their risks?
 https://www.nature.com/nature/journal/v485/n7397/full/nature11069.html; https://www.scribd.com/doc/283996769/The-Yield-Gap-For-Organic-Farming; http://rspb.royalsocietypublishing.org/content/282/1799/20141396
The Case of Glyphosate
The re-authorisation of a substance, herbicides, involvement of chemists, farmers, ghost-writers, courts, multinationals, NGOs, policy makers, and a lot of EU Legislation – these are the unlikely ingredients of a policy file whose outcome is unpredictable. Given the particular complexity and importance of this topic, I will be providing a wide range of sources for several points of this article.
The initial years
Glyphosate [N-(phosphonomethyl) glycine] was discovered by Dr. Henri Martin in 1950, a chemist working for a pharmaceutical company that sold this molecule to other companies as no pharmaceutical use for glyphosate could be identified. In 1970 Dr. John Franz, a scientist working for the company Monsanto, discovered the herbicidal properties of glyphosate and in 1974 the commercialisation of glyphosate-based herbicides started. A commercial success, glyphosate is the world´s most used herbicide (sold under many different formulations, including Roundup), and it is estimated that 8.6 billion kilograms of glyphosate active principle have been used globally between 1974 and 2016.
The approval system
Throughout the 70s and until 2002, glyphosate, as well as other chemicals, was assessed and approved for commercialisation by each country´s national authorities. This situation changed when in July 2002 glyphosate was deemed safe and approved for commercialisation at the EU level for the first time, in accordance with EU law. This authorisation extended for a period until the end of 2015, the date by when the substance should have been reassessed. So how does the assessment of chemicals work at the EU level?
First, we should take into consideration that glyphosate is an herbicide, thus falling under the EU plant protection products (PPP) Regulation. According to the PPP Regulation, the European Food Safety Authority (EFSA) is responsible for performing the risk assessment of active substances, while the European Commission will be the risk manager and take the final decision. For each substance, an application is submitted by the industry to an EU Rapporteur Member State (RMS), this RMS verifies the validity of the application, prepares a risk-assessment report (draft assessment report (DAR) or renewal assessment report (RAR)) and shares it with EFSA, Member States, and the European Commission. Next, EFSA peer-reviews the RMS report together with experts designated by Member States and with the applicants, and organises a public consultation for collecting views from stakeholders. Additional information might be requested if needed from the RMS/applicant and EFSA drafts a report (“Conclusion”) on the active substance and informs the Commission. The Commission, through the Standing Committee on Plants, Animals, Food and Feed (PAFF) where Member States are represented, votes on approval or non-approval. Based on the voting of the Standing Committee, the Commission adopts a decision which is later published in the EU official Journal. The whole process should take around 3 years. As for the authorisation periods, first authorisations can go up to 10 years while re-authorisations can go up to 15 years.
You should bear in mind that this approval system only concerns the approval or non-approval of the active substances. After a substance is approved at the EU level, it is up to each Member State to allow the commercialisation of specific products containing this substance.
EFSA and IARC
So how did this process go with glyphosate? In May 2012 the RMS, in this case Germany, received the dossier for the possible authorisation of glyphosate. In December 2013, Germany sent the Renewal Assessment Report to EFSA. In January 2014, the peer-review began, in March 2014 a public consultation was launched, lasting 60 days. In July 2014 EFSA evaluated all comments, and in August 2014, additional information was requested from the applicants. In February/March 2015, EFSA organised expert consultations in the areas of mammalian toxicology, residues, environmental fate, and ecotoxicology. In parallel to the EFSA approval system, on 20 March 2015, the International Agency for Research on Cancer (IARC) of the World Health Organisation classified glyphosate as “probably carcinogenic to humans” . In view of IARC´s conclusions, the European Commission also mandated EFSA to assess the potential carcinogenicity of glyphosate or glyphosate-containing plant protection products in the on-going peer review of the active substance. In July 2015, a Member State consultation was launched on the conclusions arising from peer review. In August 2015, Germany, the RMS, prepared the assessment of the monograph, which was circulated to Member States for comments. Following receipt of comments, EFSA organised a second expert consultation on carcinogenicity and mammalian toxicology in September. In October, Glyphosate authorisation was provisionally extended until June 2016. The peer review was updated and published in November 2015. In it, EFSA states that EFSA “concluded that glyphosate is unlikely to pose a carcinogenic hazard to humans and the evidence does not support classification with regard to its carcinogenic potential” . At this point, many scientists and environmental non-governmental organisations (NGOs) raised their voice against EFSA´s conclusions, questioning the transparency of EFSA´s analysis and pointing out that EFSA used not only open academic, peer-reviewed sources but also industry sponsored unpublished studies and data (to which EFSA was granted access), as is actually allowed by EU law. NGOs state that only IARC´s conclusions are acceptable as IARC strictly used open academic, peer-reviewed studies in their analysis.
The standing committee
As discussions surrounding glyphosate entered the public debate in many EU countries, this hot dossier finally went into the hands of the risk manager, the European Commission and the Standing Committee on Plants, Animals, Food and Feed (PAFF) where all EU Member States have a seat. This and other standing committees are used by the European Commission when approving “delegated acts” and “implementing acts”, two types of legal act which derive from the higher level legislation, “regulations” and “directives”. In the case of glyphosate, an herbicide, re-authorisation is provided via an “implementing act” and under a procedure called “examination procedure” which is activated given the importance of this dossier to the environment and to public health. Under this committee, if a qualified majority of Member States approves or non-approves a Commission´s proposal, the Commission must follow the vote. If no qualified majority is achieved, the Commission may proceed with its initial proposal, or submit a new one for voting. An Appeal Committee (also composed by Member States) is convened when there is no qualified majority and the Commission decides to advance on its own. If the appeal committee rules against the Commission’s proposed action, the Commission must abide by this decision
In March 2016, the PAFF Standing Committee did not reach a qualified majority on the re-authorisation of glyphosate. The Commission presented two revised proposals which did not gather a qualified majority decision and eventually withdrew its proposal.
European Parliament takes political action
As a major actor in the public debate on glyphosate, the European Parliament entered the discussion and on 22 March 2016, the European Parliament´s Committee on Environment, Public Health and Food Safety (ENVI) presented a motion for a resolution calling for the non-renewal of glyphosate and for the Commission and EFSA to “immediately disclose all the scientific evidence that has been a basis for the positive classification of glyphosate and the proposed re-authorisation, given the overriding public interest in disclosure” . This motion was put to plenary debate and vote and finally, on 13 April 2016, the Members of the European Parliament passed a resolution asking for a seven-year authorisation of glyphosate and to limit its commercialisation for professional uses only, among many other restrictions. This resolution has certainly had an impact on the above-mentioned PAFF Standing Committee “non-decision”.
Entropy increases – New assessment, Citizens´ Initiative, Monsanto Papers
In May 2016, a Joint Meeting of the Food and Agriculture Organization of the United Nations (FAO) Panel of Experts on Pesticide Residues in Food and the Environment and the World Health Organization (WHO) Core Assessment Group on Pesticide Residues (JMPR) published a report stating that glyphosate was “unlikely to pose a carcinogenic risk to humans from exposure through the diet.” This report uses not only IARC source studies but also unpublished papers. That same month, accusations of conflict of interest of members of this panel appeared, as well as questions regarding the apparently different conclusions of this panel and IARC´s and the comment that “WHO officials maintain there is no contradiction between the two papers, noting that IARC was identifying a potential hazard, whereas the JMPR was quantifying the associated risk.”
Taking into consideration the fact that the extension of authorisation period given to glyphosate was June 2016 (and note that the initial authorisation period was to end in December 2015) and not having an EU decision regarding its renewal, nor an agreement with Member States regarding the extension of the authorisation period, the European Commission decided to unilaterally extend (as defined by EU law) the authorisation period of glyphosate. This extension should allow for the European Chemicals Agency (ECHA) to access the possible hazardous character of glyphosate, as a dossier had been submitted in March 2016 for ECHA to give its opinion in accordance with Article 37(4) of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures. The extension is therefore of 6 months from the date of receipt of the opinion of ECHA or 31 December 2017, whichever is the earlier. By doing this, the Commission also expects that the opinion of ECHA might enable a decision by Member States at the PAFF Standing Committee.
In November 2016, as an outcome of a case opposing NGOs and the Commission where NGOs requested access to confidential environmental information from industry, the Court of Justice of the European Union decided that “when a person requests access to environmental documents, the concept of ‘ information on emissions into the environment ’ covers, inter alia , information concerning the nature and effects of the release of a pesticide into air, water or soil , or onto plants The confidentiality of commercial and industrial information may not be invoked to preclude the disclosure of such information”. In the upcoming weeks, EFSA would share redacted documents from the glyphosate review with a restricted number of members of the European Parliament who later requested a full disclosure of these documents. As stated by the European Commissioner for Health and Food Safety, Vytenis Andriukaitis, “the Commission and Member States are currently assessing the consequences of this judgement.”
In January 2017, the Commission registered a European Citizens´ Initiative (ECI) named “ban glyphosate” . This initiative invites the Commission “to propose to Member States a ban on glyphosate, to reform the pesticide/herbicide approval procedure, and to set EU-wide mandatory reduction targets for pesticide use”. If this initiative gathers sufficient validated signatures before January 2018, the Commission will have to decide whether or not it would act, and explain the reasons for that choice.
Following rumours that the German multinational Bayer wants to buy Monsanto, and the resulting concerns arising among NGOs and Members of the European Parliament, a news report came out, on 14 March 2017, stating that a court from the United States of America had disclosed correspondence from Monsanto which suggested that the company had ghost-written papers which would have been used in the EFSA´s assessment of glyphosate.
Exactly one day after the revelations regarding the “Monsanto papers”, ECHA published its conclusion on glyphosate, saying that the available scientific evidence did not meet the criteria to classify glyphosate as a carcinogen, as a mutagen or as toxic for reproduction, thus not classifying it as a carcinogen. As in EFSA´s review, ECHA used both published scientific studies and undisclosed industry studies in its review.
In May 2017, the European Commission questioned EFSA regarding possible implications of the “Monsanto Papers” in EFSA´s scientific review. EFSA clarified that the two papers mentioned in the “Monsanto Papers” and used in EFSA´s review have a minor impact in the overall evaluation and that EFSA mainly used the papers´ raw data to produce its own conclusions.
The Commission will be presenting a new proposal on glyphosate later on this year, which will again have to pass in the standing committee. In the meantime some Members of the European Parliament are calling for an Inquiry Committee to investigate the Monsanto Papers and their implications on glyphosate´s assessment
As I finish writing this article, there are still many unknowns regarding the future of glyphosate. The Commission will be presenting a new proposal on glyphosate later on this year, which will again have to pass in the standing committee. In the meantime some Members of the European Parliament are calling for an Inquiry Committee to investigate the Monsanto Papers and their implications on glyphosate´s assessment. EuCheMS is also getting involved in the debate and has recently published a series of conclusions from a workshop on glyphosate co-organised with Pavel Poc, Member of European Parliament, and ECTN, where among other measures EuCheMS calls for more transparency in the assessment of substances by using Horizon 2020 to publicly fund and publicly make available the studies submitted by industry when preparing an application. Whatever is the outcome for this particular substance, it is crucial to support chemists and their research in developing new substances, assessing substances, designing new analytical methods, to keep on the scientific debate and to provide the best available science to policy-makers and to society.
 Directive 91/414/EEC concerning the placing of plant protection products on the market http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:31991L0414. This Directive (a EU law that must be transposed into each EU Member State´s national law) was later substituted by Regulation No 1107/2009 concerning the placing of plant protection products on the market (http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32009R1107) (a Regulation is a EU law that is automatically transposed as EU Member State´s national law).
 http://www.consilium.europa.eu/en//council-eu/voting-system/qualified-majority/ – a qualified majority needs 55% of member states, representing at least 65% of the EU population
 http://www.europarl.europa.eu/news/en/press-room/20160321IPR20296/glyphosate-herbicide-don-t-renew-its-authorisation-urge-meps ; http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+TA+P8-TA-2016-0119+0+DOC+XML+V0//EN
 http://www.reuters.com/article/us-monsanto-m-a-bayer-deal-idUSKCN11K128; http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+WQ+E-2016-009504+0+DOC+XML+V0//EN; http://ec.europa.eu/competition/elojade/isef/case_details.cfm?proc_code=2_M_8084; https://whowhatwhy.org/2016/06/19/monsanto-binge-bayer-dictate-eat/
 https://www.nytimes.com/2017/03/14/business/monsanto-roundup-safety-lawsuit.html; https://www.bloomberg.com/news/articles/2017-03-14/monsanto-accused-of-ghost-writing-papers-on-roundup-cancer-risk
EuCheMS Public Affairs Officer