A critical examination of the protection level for primary producers in the first tier of the aquatic risk assessment for plant protection products

Author:

Sabine Duquesne,Stephan Brendel,Linda Hönemann,Marco Konschak,Magali Solé,Joern Wogram,Silvia Pieper

Abstract

Abstract Background The aim of environmental risk assessment (ERA) for pesticides is to protect ecosystems by ensuring that specific protection goals (SPGs) are met. The ERA follows a prospective tiered approach, starting with the most conservative and simple step in risk assessment (RA) (so-called tier 1) using the lowest available appropriate endpoint derived from ecotoxicological tests. In 2015, for the tier 1 RA of aquatic primary producers, the recommendation was changed from using the lowest of the 50% inhibition (EC50) values based on biomass (area under the curve—EbC50), increase in biomass (yield- EyC50) or growth rate (ErC50) to only using the growth rate inhibition endpoint (ErC50) because it is independent of the test design and thus more robust. This study examines the implications of this such on the level of conservatism provided by the tier 1 RA and evaluates whether it ensures a suitable minimum protection level. Results Our analysis shows that replacing the lowest endpoint with the growth rate inhibition endpoint while maintaining the assessment factor (AF) of 10 significantly reduces the conservatism in the tier 1 RA. Comparing protection levels achieved with different endpoints reveals that the current assessment is less protective. To maintain the previous level of protection, and since the protection goals have not changed, we recommend to multiply the default AF of 10 by an extra factor of minimum 2.4 in the tier 1 RA based on ErC50. Independently of the endpoint selected in tier 1 RA, several issues in the general RA of pesticides contribute to uncertainties when assessing the protection levels, e.g., lack of appropriate comparison of the higher tier experimental studies (i.e., best achievable approximation of field situation, so-called surrogate reference tier) with field conditions or the regulatory framework's failure to consider realistic conditions in agricultural landscapes with multiple stressors and pesticide mixtures. Conclusions We advise to consider adjusting the risk assessment in order to reach at least the previous protection level for aquatic primary producers. Indeed continuing using an endpoint with a higher value and without adjustment of the assessment factor is likely to jeopardize the need of halting biodiversity loss in surface waters.

Funder

Umweltbundesamt

Publisher

Springer Science and Business Media LLC

Subject

Pollution

Reference27 articles.

1. European Commission (2009) (EC) Regulation No 1107/2009 of the European parliament and of the council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJ L 309/1, 24.11.2009: 50 pp.

2. European Commission (2013) Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market. OJ L 93, 3.4.2013: p 84

3. European Commission (2013) Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market. OJ L 93, 3.4.2013:68, p 68

4. European Commission (2001) Working Document Guidance Document on Aquatic Ecotoxicology in the context of the Directive 91/414/EEC. SANCO/3268/2001 rev.4 (final) 17.11.2002: 62pp.

5. European Commission (2011) Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products. OJ L 155/127, 11.6.2011: 49pp.

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