Europe’s pesticide regulations aim to ensure a high level of protection of human, animal and environment health. An important part of the law is that certain harmful pesticides, including those that cause cancer or are endocrine disrupters (disrupt hormones, EDCs), cannot be approved unless there is ‘negligible exposure’ of people and the environment to them under realistic conditions of use. CHEM Trust is concerned that the EU is trying to weaken this requirement, which would mean that these hazardous chemicals can continue to be used.
The European Commission has been developing a guidance document to explain how the principle of ‘negligible exposure’ should be applied. Initially these discussions were taking place behind closed doors, between the European Commission and Member States experts. In 2014 Pesticides Action Network (PAN) used the ‘access to documents’ procedure to get some information on these discussions. These papers showed that Sweden and potentially other Member States were very concerned with the way that the European Commission was drafting its guidance.
Eventually DG Sante, the part of the European Commission responsible for health and food safety, organised a stakeholder meeting in June 2015, where they presented the draft guidance. CHEM Trust provided written comments on this draft guidance document, arguing that it would undermine the current EU pesticide law. While we agreed that consumer uses should be excluded (and therefore not allowed to be considered negligible exposure), we fear that the approach taken would undermine the current EU pesticide law. Our particular concerns included:
- The text of the law specifies that for ‘negligible exposure’ the pesticide should be used in closed systems or in other conditions excluding contact with humans. However, the draft Commission guidance interpreted ‘negligible exposure’ as just a ‘stricter than usual risk approach’, thereby turning the interpretation from ‘negligible exposure’ to ‘negligible risk’. This interpretation will not ensure that there is no contact with humans, e.g. via drift exposure to neighbours or people enjoying a day out in the countryside.
- The scope of ‘negligible exposure’ appears to be too narrowly defined, with the main focus on dietary exposure. The law places the emphasis on negligible exposure during application, i.e. to workers applying the pesticide.
- Consideration of negligible exposure of non-target organisms in the environment is missing.
- The list of scenarios given reflect existing agricultural practice, rather than a modification of practice and strict conditions to ensure ‘negligible exposure’.
The interpretation in this draft guidance document from the Commission would mean that substances that should be banned under EU regulations because they are linked to serious health issues (i.e. cause cancer, affect reproduction, or interfere with hormonal system), could still be allowed to stay on the market. We agree there may be exceptional cases for an authorisation based on very strictly controlled use scenarios and under certain conditions, but opening the door widely is unwise and is not in line with the legal text.
Comments from other stakeholders, and the minutes for the June 2015 meeting, are available on DG Sante’s website.
This guidance has not been adopted yet, but once it is we expect it to be applied for the first time in the discussion on renewals of authorisation of several pesticides, so it is important to get it right.
At the end of January, the EU’s Standing Committee on Plants, Animals, Food and Feed – made up of representatives of EU Government and the European Commission – met to continue their discussions on this issue and other regulatory matters relating to pesticides. A new draft technical guidance document on ‘negligible exposure’ was on the agenda; but at the time of writing this version of the guidance document was not yet publically available. We therefore don’t know if our concerns have been taken on board.
Ninja Reineke, Senior Policy Adviser to CHEM Trust, said:
‘It’s high time for more transparency on this important issue. We need certainty that a guidance document cannot re-interpret EU law and open the door for continued use of cancer causing and hormone disrupting pesticides. This would weaken the protections originally intended in the law, risking human health and the environment’
The derogation option
It’s important to note that demonstrating ‘negligible exposure’ is not the only route by which a particularly hazardous pesticide could continue to be used. The EU’s main pesticides law also includes the option of temporary derogations, in Article 4(7):
“where on the basis of documented evidence included in the application an active substance is necessary to control a serious danger to plant health which cannot be contained by other available means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years… provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised”
This means that hazardous pesticides can continue to be used under special provisions, while more sustainable options and safer alternatives are explored.
- The EU Crop Protection Association has a presentation on their web site spelling out the pesticide industry’s view on how this derogation should be applied. The presentation points out that the derogation is renewable [Update Nov 2016: This presentation appears to have been removed from the ECPA website].