Finding the line between commercially sensitive information and public and environmental protection
When it comes to chemical regulation, data is key to decision making. An investigation by Swedish academics Axel Mie and Christina Rudén of Stockholm University, reported in the Guardian in June, suggested that several pesticide manufacturers withheld data from brain toxicity studies conducted in the 2000s from EU regulators (as it was not explicitly required at the time), while the data was provided to US regulators, whose requirements were different.
The European commission has now stated that it considers omissions by agrochemical giants Bayer and Syngenta to have breached the companies’ legal obligations in reporting data to the regulators.
Is it justifiable to omit existing data that could be relevant to decisions around safety and risk, simply because it is not legally required? Even when that data is included in submissions to regulators elsewhere? Companies might argue that it is – it is up to the regulator to be clear what information is required, and if a submission fulfils those requirements then a company has discharged its duty.
The companies involved also assert that the data would not have affected the EU approval decisions, although the academic team suggests that in several cases, regulations were tightened after EU regulators became aware of the studies. The EU has since closed this loophole and requires all industrial studies to be pre-registered if they are to be included in regulatory submissions, and reported regardless of their outcome. However, it may be several years before some existing products’ approvals are reviewed.
While this investigation focuses on one particular type of testing, and only on pesticides, it raises important questions about companies’ rights to keep certain data private. Recent months have seen accusations of data suppression against the manufacturers of per-and ployfluorinated substances (PFAS) relating to the compounds’ toxicity, as well as against oil and gas major ExxonMobil relating to its projections of the climate change its products would contribute to.
There is a fine line between allowing firms to keep commercially sensitive information private from competitors, while encouraging innovation but also ensuring adequate disclosure to protect public safety. But at the same time, the nature of commercial operations means it is almost impossible to know exactly what information such companies are holding (and potentially hiding) – these latest documents have only come to light through major court cases. It seems almost inevitable that such revelations will continue.