Some fact-based perspective on the influence of Monsanto on regulation

Global agrochemical player Monsanto tampered with some research studies that had to proof the safety of the herbicide Roundup containing glyphosate. According to professor Pieter Spanoghe from Ghent University, the company only had a small influence on the final authorisation. More general education and transparent communication on the regulatory process of crop protection products would benefit everybody. That is why education is also the theme of a global crop protection conference he is organizing in 2019.

The ‘Monsanto Papers’ revealed that the agrochemical company Monsanto had written their own scientific studies to prove the safety of glyphosate and just asked some scientists to sign it with their name.

Glyphosate, the working substance in Monsanto’s herbicide Roundup, has been a subject for discussion for a long time. In 2015, the International Agency for Research on Cancer (IARC) from the World Health Organisation (WHO) has classified glyphosate as ‘probably carcinogenic’. Later that year, the European Food Safety Agency (EFSA) evaluated the research on glyphosate and concluded that it ‘probably does not contain any carcinogenic danger for humans’.

Claiming that EFSA has labelled glyphosate as safe ‘because’ Monsanto has influenced the research, like some media do, is a bridge too far, says Pieter Spanoghe, expert on crop protection (chemistry) at Ghent University. “The evaluation of EFSA was based on hundreds of studies. Glyphosate has been on the market since the 1970’s and there is a huge amount of literature available on the crop protection ingredient. Monsanto can try to bend some publications to their will, but those will not tip the scale in the direction the company wants.”

“Besides, let us not be naïve”, adds Spanoghe. “The opponents, who want glyphosate to be forbidden, also rely on some questionable research. Just think about the infamous Séralini study from some years back which had to prove that genetically modified maize and Roundup gave rats cancer.” There are always positive and negative scientific studies to be found on every important subject, but what really counts is the scientific consensus and how long this has been more or less the same. Even EFSA minimalizes the impact. “Most studies mentioned in the so called ‘Monsanto papers’ were only published after EFSA had finished its evaluation and did not play any role in their judgement”, says spokesman Flavio Fergani. “Among the 700 references, there are only two studies that are mentioned in the papers. Besides, those were retrospective studies, while EFSA attaches much more importance to original studies.”

The number of studies mentioned in the ‘Monsanto papers’ is limited. However, a significant amount of the toxicological studies were commissioned by the industry. “More independent toxicological research is necessary”, thinks Lode Godderis, connected to the research group Environment and Health from the University of Leuven. "If you only have access to those studies, and if you are lucky the raw data included, it is hard to detect fraud.”

“According to the European regulations, the producer is responsible for proving the safety of the product it wants to commercialize”, remarks Fergani. “That system has already led to the prohibition of dozens of harmful pesticides, based on the advice from EFSA. Ironically, it is the same system that EFSA has used to evaluate the impact of neonicotinoids on bees. The people who are now criticising EFSA, were praising it back then.”

Harmful or not?

So, is glyphosate carcinogenic or not? After analysing the research on farmers and other professional users, WHO-scientists have concluded there is ‘limited’ proof the exposure to glyphosate causes cancer. Some studies do indicate a connection between higher exposure to glyphosate and an elevated risk for non-Hodgkin’s lymphoma. However, most other studies do not show any connection with this or other types of cancer, including a large and well conducted study that observed 50.000 American farmers. On the other hand, the IARC claims there is ‘sufficient’ evidence that glyphosate can cause cancer in test animals, and ‘strong’ evidence the substance can damage DNA.

EFSA thinks differently. The fact that scientists do not agree about the health effects of a substance is not that strange. While evaluating research, they have to determine which studies are of high quality and the results have to be interpreted. Opinions can differ on that.

The IARC and EFSA do not have the same goal. IARC checks if a substance can cause cancer, in a certain dose or under certain circumstances. Independent of the probability of those scenarios. EFSA evaluates the risk of a substance causing cancer, taking into account the expected exposure. This is important to take into account because the dose always makes the poison. Even water can be lethal depending on the exposure. Besides, EFSA only studied glyphosate, but IARC also evaluated mixtures that contain glyphosate.

According to the EFSA, the damaging results the IARC found could also come from other substances in those mixtures. “If they do not measure with the same rulers, they can keep quarrelling”, says Spanoghe. “I also see two institutes claiming they are the best. But internally, they do know their evaluations were conducted differently.”

Farmer vs. consumer

“Most studies concerned people who use the product professionally”, says Godderis. “We do not know as much about the exposure of consumers and the risks for them. The label ‘carcinogenic’ refers to the potential danger of a substance. The risk of you actually getting cancer, depends on the degree and time of the exposure. If a substance is carcinogenic, you prefer not to be exposed to it, but it does not mean you will inevitably get cancer after any form of exposure.” According to Spanoghe, we do not have much to fear as consumers. “The IARC also labelled red and processed meat as carcinogenic. If you eat that daily, you are at higher risk than someone who only eats it once a month. With glyphosate, it is the same story. Not many people use it every day.”

IUPAC 2019 Crop Protection Congres

Professor Spanoghe will organize the IUPAC 2019 global congress on crop protection that will come to Ghent in May 2019. This four-yearly event can be seen as the Olympics in crop protection. The theme will be ‘education of the future generation’, because future researchers, farmers and the general public need to be properly educated globally on the science and use of crop protection. This also includes the complexities of the regulatory process.

This article was also published earlier this year in EOS Science in Dutch.