Is the European Crop Protection Industry Threatened By the Drive Toward Transparency?
Editor’s note: This article first appeared in Outlooks on Pest Management, April 2019, pages 50-52.
From 23-26 May 2019 EU citizens will be given the opportunity to select who will represent them in the European Parliament for the next five years. They will help determine how Europe will act to address public concerns such as the state of the economy, jobs, security, migration, climate change, and food security. Given that the term of the current incumbents is almost up it seems appropriate to review their time in charge to determine whether science and science-based rationale are still central to EU decision-making. From a crop protection industry perspective, the period 2014 to 2019 will likely be remembered for the debacle surrounding the renewal of glyphosate, concerns over data transparency and independence, and attempts to improve the Plant Protection Product (PPP) authorization process.
The Role of the European Parliament, Council and Commission
The EU has a unique set-up. The EU’s broad priorities are set by the European Council, which brings together national and EU-level leaders to set the EU’s political agenda. It represents the highest level of political cooperation between EU countries and is presided over by its President, Donald Tusk. Directly-elected MEPs, under the guidance of the President of the European Parliament, Antonio Tajani, represent European citizens in the European Parliament, which has three main roles: (1) Legislative, e.g., passing EU laws, together with the EU Council, based on Commission proposals; (2) Supervisory, e.g., electing the Commission president and approving the Commission as a body, democratic scrutiny of all EU institutions, and examining citizens’ petitions and setting up inquiries; and (3) Budgetary, e.g., establishing the EU budget, together with the Council, and approving the EU’s long-term budget.
The interests of the EU as a whole are promoted by the European Commission (hereafter referred to as the Commission), whose members are appointed by national governments and whose current president is Jean-Claude Juncker. The Commission is the EU’s politically independent executive arm. It is alone responsible for drawing up proposals for new European legislation, and it implements the decisions of the European Parliament and the EU Council. Each government defends their own country’s national interests in the Council of the European Union.
Scientific Decision-Making in Europe
The mechanism supporting science in the EU is complex. When President Juncker was appointed in 2014 one of his first actions was to allow the role of EU Chief Scientific Advisor (CSA) to expire, and in so doing, Prof Anne Glover was removed from the role that she had been appointed to by the former head of the Commission, Jose Manuel Barroso. Her mandate was to provide “independent expert advice on any aspect of science, technology and innovation as requested by the President.” However, she disagreed with the official EU position on Genetically Modified (GM) crops with her open support of the technology.
It was widely accepted that President Juncker did not support the CSA role and its expiry was perhaps influenced by environmental campaign groups including Pesticide Action Network who wrote to President Juncker citing concerns over transparency. In 2015, Europe’s commissioner for research, science, and innovation, Carlos Moedas, announced the replacement for the singular CSA role with the formation of the Group of Chief Scientific Advisors (the Group), a high level expert advisory group consisting of up to seven distinguished scientists reflecting the breadth of scientific expertise across Europe, and whose role is to provide independent scientific advice to the College of European Commissioners (the College) to inform their decision making, in line with the Better Regulation agenda. The College is led by President Juncker and members include Commissioner Vytenis Andriukaitis (Health & Food Safety) and Commissioner Phil Hogan (Agriculture & Rural Development).
The Group is supported by a secretariat in the Commission’s Directorate General (DG) for Research and Innovation, to which staff from the Joint Research Centre (JRC) and national experts are seconded and works closely with the Horizon 2020 funded SAPEA (Scientific Advice to Policy by European Academies) project. The secretariat also enables links to other science advisory bodies in Europe such as the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA), and worldwide. Collectively, the Group, SAPEA and the secretariat are known as the Scientific Advice Mechanism (SAM). According to the Commission, the Group and SAPEA work together to allow the Group to provide high quality, independent, and timely input to policy, based on different forms of evidence reviews, ranging from literature reviews to expert elicitation.
The Rise of Pseudoscience
The International Agency for Research on Cancer (IARC, an agency of the World Health Organization) classification that glyphosate is “probably carcinogenic to humans” put scientific conduct firmly in the spotlight. IARC chose to ignore the several thousand industry studies on glyphosate due to concerns over industry influence and conflicts of interest, and instead relied on only a small number of publicly available studies on which to base its conclusions. Perversely, one of the co-authors on the glyphosate monograph, Christopher Portier, had a role working for the Environmental Defense Fund (EDF), an NGO known to have an anti-pesticide stance. Portier himself has stated that his work for the EDF was only to provide advice on topics such as climate change and testing methods for evaluating chemical toxicity, and thus it will probably never be known whether his involvement in the glyphosate review made a difference to the outcome. However, this case highlights concerns with the current conflicts of interest protocol: the drive towards transparency and independence effectively rules out anyone with an industry background from taking part in the expert scientific committees; yet, it does not stop people who may have an anti-industry stance taking part (e.g., see Blake 2017).
Subsequent reviews by the EFSA and ECHA concluded that glyphosate is unlikely to pose a carcinogenic hazard to humans, and following disagreements between EU Member States, the EFSA and the Commission, glyphosate was finally renewed in 2017, albeit for a reduced period of five years. However, the damage had already been done; what is often misunderstood is that the IARC evaluates “hazard” – the possibility that a substance could cause cancer no matter how irrelevant to actual human exposure – rather than “risk”, the likelihood that actual exposure in the real world might cause cancer. The problem is that the general public, including the media and politicians, generally do not have this level of understanding, and so associate a classification that something is “probably carcinogenic” with having some direct relevance to human health. The scaremongering surrounding glyphosate, conducted by sections of the media, several NGOs and the less well-informed amongst the general public, has effectively led to the rise of pseudoscience whereby beliefs or theories are considered to be scientific yet have no basis in scientific fact.
Focus on Data Transparency and Independence
In February 2018, following the Commission’s renewal of glyphosate, and to help address the growing public concerns highlighted during the renewal process, the European Parliament set up the Special Committee on the Union’s authorization procedure for pesticides (PEST). Thirty members were selected from across the Parliament’s political groups to evaluate the current two step system for approval and authorization of pesticides in the EU, its independence from industry, the transparency of the decision-making process, and the roles of all stakeholders involved, especially the EFSA, the Commission and the national Member State competent authorities. Experts and stakeholders who were questioned at the PEST hearings included the SAM Group (of Chief Scientific Advisors), Member State competent authorities, EFSA, ECHA, various academics, environmental NGOs including Greenpeace and the Corporate Europe Observatory, farmer groups such as COPA-COGECA, the European Crop Protection Association (ECPA), and the private consultant Christopher Portier.
The final PEST report was published in December 2018 and voted on by the Parliament in January 2019. Recommendations include a move to a single-step risk management process for active substance approval and PPP authorization to improve value and efficiency; funding to promote independent research on the effects of PPPs on human and animal health, the environment and agricultural production, and research into alternatives to conventional PPPs, including non-chemical methods, and low-risk pesticides; and suggesting that independent risk assessment would allow trust in the PPP Regulation (EC No. 1107/2009) and the EU Food Law. It is recommended that this could be achieved by requiring that the applicant no longer assesses the data themselves as part of the application for active substance approval, nor conducts a review of the scientific peer-reviewed open literature, instead assigning both of these tasks to the Rapporteur Member State, with assistance from EFSA. Furthermore, it is recommended to give equal weight to both scientific peer-reviewed open literature and GLP-based studies considering that they are both valid as contributions to the assessment and should be weighted according to the relative quality of the studies and their relevance to the application under consideration.
The PEST Committee recommendations are intended to help address the growing public concerns over the current authorization procedure for pesticides. The current EU authorization procedure for PPPs is already considered to be one of the most stringent in the world. The drive towards the use of independent data implies anything from industry is considered biased even though industry standards such as Good Laboratory Practice and adherence to internationally agreed OECD protocols ensure that studies are transparent and reproducible. That level of scrutiny does not exist within the publicly available scientific open literature; yet, the implication is that industry is not to be trusted and should not be allowed to influence the decision making process.
The crop protection industry has taken on board the criticism, and ECPA, CropLife International and their member companies have launched their own transparency commitment to ensure that more data related to the safety of its products are made publicly available. This represents a logical, rational, and scientific approach to improving public education; alienating industry from the discussions and decision-making process does not.
Back in 2014 when Prof Anne Glover’s role as EU Chief Scientific Advisor was allowed to expire, Prof Sir Paul Nurse, president of the Royal Society, warned that “Scientific advice must be central to EU policy making, otherwise you run the risk of having important decisions being unduly influenced by those with mixed motives.” Reflecting now in 2019 one could conclude that important decisions are being unduly influenced by those with mixed motives, to the detriment of scientifically based decision making and industry, and the advantage of pseudoscience. The recently appointed Parliament rapporteur, MEP Pilar Ayuso, may be on the right track when she said that “I understand the objectives of transparency, of guaranteeing the level of protection of human health, the increase of consumer confidence or the reduction of administrative burdens… however, we must avoid that the results of scientific opinions are still being questioned on the basis of ideological factors that undermine innovation and competitiveness.”
If industry is going to play an important role in European agriculture in the coming decades, then the hope is that more people like Pilar Ayuso will be elected to represent Europe later this year.