SETAC Spotlight: Developments in pollinator risk assessment

In July 2022, the European Food Safety Authority (EFSA) released a draft updated guidance on the risk of plant protection products to bees for public commenting¹. In October 2022, the 15^th International Symposium on the Hazards of Pesticides to Bees (organized by the International Commission for Plant Pollinator Relationships (ICPPR)) was held in the UK².

This poster³ (presented at SETAC Dublin 2023) aimed to summarise key concerns raised in the public commenting period of the draft guidance, and the clarifications (if any) provided on these topics at the ICPPR conference.

Some of the key concerns we noted during the public commenting period on the draft new bee guidance were as follows:

• The high complexity of the new risk assessment and the lack of a calculator tool (making it difficult to assess impact)
• The new Time-Reinforced Toxicity (TRT) assessment – this relies heavily on effects observed in the 10 day toxicity study. There was concern that low toxicity substances would be penalized because if lack of TRT cannot be proven from the toxicity profile over time (due to lack of any toxicity), the default worst case assumption must be used
• It was unclear whether studies were always required for non-Apis species, and what (if any) risk assessment should be performed due to the lack of protection goals

ICPPR provided a useful forum for discussion amongst many different stakeholders. However, answers to these issues from EFSA were, unfortunately, limited.

More recently, on the 11^th May 2023 (after the SETAC Dublin conference), EFSA published a revised version of the bee guidance document. To supplement this, EFSA presented an online information session on the bee guidance document in June (details and a recording of which can be found on the EFSA website). The intention of this event was to present a summary of the revised guidance document and (in contrast to the comparable bird and mammal guidance document information session held in April) to provide stakeholders with the opportunity for live Q&A with the presenters.

The 4 hour information session was a useful summary of the guidance document but was considered by us to be too short to cover the level of technical detail required for such an extensive and complex document (>>1000 pages including appendices and annexes). There was also a large influx of questions during the live session, including some relating to the issues highlighted above. However, there was not time for all of these questions to be addressed by EFSA.

Though by no means a comprehensive list, some useful things to note from the session are listed below:

• The revised GD is expected to be noted earliest Spring/Summer 2024. EFSA do not seem to foresee any issues with the noting of the guidance (which was not the case with the 2013 bee guidance). There will be a transitional period, but no indication of duration was provided.
• EFSA stated that a calculator tool was in development and they hope for it to be available alongside the noting of the guidance document. They plan to test it, possibly with stakeholders as was done for the bird and mammal calculator. It will be web-based with no storing of data (for data protection reasons).
• The TRT assessment requires TKTD modelling (using the GUTS model), which may be built into the EFSA calculator tool.
• There is now a filtering step for the TRT assessment in the updated GD: if <10% mortality occurred in the 10-day chronic study (OECD 245) at any dose ≥100 µg/bee per day à no TRT assessment is required. However, this does not solve some concerns with the assessment: that it relies heavily on the results from the 10-day chronic study, and that it may penalize low-toxicity substances which cannot be tested at ≥100 µg/bee per day due to solubility or palatability issues. It was also suggested that there may be ways around the TRT assessment not outlined in the guidance document, e.g. where exposure can be proven to be <10 days in the wild.
• The status of non-Apis bees is still uncertain, and specific protection goals (SPGs) are still unavailable. EFSA stated that until further data become available, field studies on bumblebees and solitary bees will be required, unless a) the lower tier RA for honeybees and non-target arthropods other than bees (NTAs) show no effects for the active substance, or b) semi-field studies with bumblebees and solitary bees show absence of effects, and c) semi/field studies with bumblebees wouldn’t be needed if studies according to OECD 246 and 247 (acute contact/oral bumblebee tests) have an LD50 of >100 µg a.s./bee. The question was raised as to whether “no effect on NTAs” meant passing the lower tier risk assessment or no effect in the studies themselves. EFSA stated that this needed to be further clarified in the GD.

We recommend anyone concerned about the potential impact of the revised pollinator guidance document on their submissions to review the presentations provided by EFSA in the information session, if you haven’t already.

If you would like to discuss any of the topics raised in this article, feel free to contact us.

The poster is available for free download.

You can find all of the other posters that CEA presented at SETAC Dublin here. You can also find all of our publications from previous conferences and links to journal articles we have authored on our library page.

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References

1. EFSA Revised guidance on the risk assessment of plant protection products on bees (Apismellifera, Bombus and solitary bees). Draft released for public consultation (2022).
2. International Commission for Plant Pollinator Relationships (ICPPR) Bee Protection Group 15^th International Symposium. York, United Kingdom. October 18-21 2022. https://bpg-meeting.julius-kuehn.de/
3. Crosland H, Weyman G. Developments in the Pollinator Risk Assessment Following the New EFSA GD and ICPPR. 2023. https://cea.adas.co.uk/wp-content/uploads/2023/05/Crosland-et-al-Developments-in-the-pollinator-RA.pdf