Scientists warn: Systemic failures allow hazardous pesticides to be approved – stricter oversight urgently needed

EU chemical legislation is designed to guarantee a high level of protection for human health, but in practice the level of protection is not as strong as it should be. This is the conclusion of Axel Mie and Christina Rudén at Stockholm University, who have scrutinised an industry study that preceded the EU's market approval of the fungicide fluazinam in 2008.

The new scientific analysis of industry-funded toxicity data for fluazinam, currently undergoing peer review, has been made publicly available as a preprint. It identifies a series of shortcomings in the process by which fluazinam was approved. The manufacturer commissioned a developmental neurotoxicity (DNT) study examining the substance's effects on brain development, but six instances of false statistical reporting by the testing laboratory collectively obscured harmful effects on brain development in rat offspring. When the researchers re-analysed the same data, they were able to identify significant adverse effects on both brain weight and brain dimensions.

“The false reporting caused adverse effects on brain development to be obscured and therefore go undetected in the authorities' original assessment,” explains Axel Mie. “Had the results been reported correctly, the substance would in all likelihood never have been approved.”

Series of failures in the approval process

The researchers' study also reveals several other weaknesses in the regulatory system. In violation of the applicable rules, the DNT study was withheld by the pesticide producer from regulatory scrutiny for 15 years – and submitted only after the authorities had specifically requested it. It was one of several such studies submitted to regulatory authorities in the United States, but not in the EU.

When the authorities subsequently reviewed the DNT study, the false statistical reporting was not detected. Even after researchers at Stockholm University informed the authorities of clear indications of harmful effects on brain development, the authorities neither conducted nor requested more appropriate statistical analyses. They simply referred once more to the results as reported by the manufacturer, and in assessing whether these results should be considered harmful, applied a threshold that the researchers argue is insufficiently protective of human health.

“Taken together, this chain of errors and misjudgements means that children may have been exposed to avoidable risks to brain development during the years fluazinam has been on the market – particularly those living near fluazinam-treated fields and plantations,” says Axel Mie.

Fluazinam's EU market approval is currently under evaluation.

“In my opinion, it is unlikely that fluazinam will receive renewed approval, given the severity with which the effects identified here are viewed under the regulatory framework,” says Axel Mie.

Structural problems in regulatory oversight

The case of fluazinam illustrates structural problems in how pesticides are regulated in the EU, according to Axel Mie and Christina Rudén. The current system places responsibility on manufacturers themselves to commission toxicity studies of the substances for which they seek market authorisation. This creates a conflict of interest that is particularly problematic given the complexity of the studies involved and the difficulty of detecting errors.

“The fluazinam case is yet another demonstration that the current system is inadequate when it comes to protecting both human health and the environment,” says Christina Rudén.

At the same time, there is strong industry pressure to simplify and streamline EU rules for pesticide approval. This has resulted in a proposed legislative package – the so-called Food and Feed Safety Omnibus – which is scheduled for discussion in the European Parliament's Committee on Environment, Public Health and Food Safety and Committee on Agriculture and Rural Development (ENVI and AGRI) on 6 July.

The researchers warn that the proposed Omnibus package risks further worsening the current situation. They have therefore produced a policy memo with recommendations for the decision-makers involved in the process. Among other things, they propose that toxicity studies should in future be commissioned by public authorities rather than by the chemical industry, and that a broad review be conducted of how industry-sponsored chemical safety studies are used.

“What is needed is increased resources for the responsible authorities, stronger regulatory oversight, and more thorough independent scrutiny of industry-funded studies. Deregulation would be a step in entirely the wrong direction”, concludes Christina Rudén.

Text: Lisa Bergqvist

Further reading

Pre print of the scientific study:
Hidden Neurotoxicity: Re-analysis of an industry study reveals obscured brain developmental effects of fluazinam and failures in EU oversight

Policy memo with recommendations for policy makers:
Fluazinam exposes failures in the EU’s pesticide approval system

News article in the Guardian:
EU-approved pesticide found to have potential effects on brain development