The European Food Safety Authority (EFSA) was asked by the European Commission (EC) to develop a Guidance Document on the risk assessment of plant protection products on bees. The Guidance Document is intended to provide guidance for notifiers and authorities in the context of the review of plant protection products (PPPs) and their active substances under Regulation (EC) 1107/2009. The scientific opinion on the science behind the development of a risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees) (EFSA Panel on Plant Protection Poducts and their Residues (PPR), 2012a) provided the scientific basis for the development of the Guidance Document. The process of the development of the Guidance Document follows the methodology of definition of specific protection goals (SPGs) as outlined in the scientific opinion of EFSA‘s Plant Protection Products and their Residues Panel (EFSA Panel on Plant Protection Products and their Residues (PPR), 2010). The Standing Committee on the Food Chain and Animal Health was consulted for the appropriate levels of protection (e.g. to make choices on the magnitude of effects, duration of effects and exposure percentiles). The Guidance Document suggests the implementation of a tiered risk assessment scheme with a simple and cost-effective first tier to more complex higher tier studies under field conditions. Each of the tiers will have to ensure that the appropriate level of protection is achieved. More detailed guidance on specific aspects of laboratory studies and higher tier risk assessments is given in the appendices. A need for test protocols for bumble bees and solitary bees was identified. Potential protocols are available in the published literature and first proposals are made in the appendices. It is important that fully validated test protocols are developed in future.
Source: EFSA, 4 July 2013
http://www.efsa.europa.eu/en/efsajournal/pub/3295.htm
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EFSA adopts approaches proposed by Tennekes & Sánchez-Bayo
In Appendix O [EFFECTS STUDIES—PROTOCOLS, GUIDANCE AND GUIDELINES FOR HONEY BEE, BUMBLE BEE AND SOLITARY BEE] of the document (on page 206) EFSA refers to the following equation:
C × t˄b = L
where the time exponent b > 1.
which is of course the Druckrey-Küpfmüller equation. EFSA has clearly adopted the risk assessment approaches proposed by Tennekes and Sánchez-Bayo, but neither gives the equation its proper name nor credit to these authors. In the preceding Scientific Opinion of EFSA [EFSA Journal 2012;10(5):2668] reference is however made to these authors:
"Recently, concern has been raised over the repeat dose or long-term exposure of bees to pesticide residues that may bioaccumulate. Such pesticide residues may have repeat dose effects that may potentially have more dramatic health effects compared with their short-term effects (Tennekes, 2010; Tennekes and Sanchez-Bayo, 2011)."
In the Scientific Opinion addressing the state of the science on risk assessment of plant protection products for non-target arthropods published by EFSA (EFSA Journal 2015;13(2):3996) it is stated that "Recently it has been shown that also some insecticides may exhibit delayed and time-cumulative effects in non-target arthropods (NTAs). Rondeau et al. (2014) estimated that imidacloprid at a concentration of 0.25 μg/kg would be lethal to a large proportion of overwintering bees, and similar delayed effects are expected also in ants and termites. The authors concluded that ‘chronic tests for pesticide toxicity to pollinators should be extended to 30 days or more and use time-to-effect measurements’. It should be stressed in this respect that Rondeau et al. (2014) considered only effects on mortality, and not on fecundity. Thus, the overall delayed effects on population dynamics are expected to be even more serious. Such studies support the need to implement long-term tests in ERA, based on chronic exposure of invertebrates to potentially toxic chemicals. Only such studies will make possible predicting population-level effects of plant protection products (PPPs) under realistic exposure scenarios. The NTA working group stands on the position that development of such chronic tests, covering a significant part of a species life history and allowing for assessment of reproductive effects of PPPs, should be one of the most crucial and urgent tasks in modern ecological risk assessment (ERA). Recognising that this may result in more time-consuming and costly tests, the working group suggests that chronic and reproductive effects of PPPs could be performed on species with relatively short life cycle and easy to maintain in a laboratory. A good candidate would be a multi-generation test with Drosophila species, such as D. melanogaster. Both the acute and chronic effects can be studied with such a test in short time. The additional advantage of D. melanogaster is that with such a well studied species, with known genetics, it would be possible to select appropriately sensitive strains.
Full reference:
Rondeau G, Sanchez-Bayo F, Tennekes HA, Decourtye A, Ramirez-Romero R and Desneux N, 2014. Delayed and time-cumulative toxicity of imidacloprid in bees, ants and termites. Scientific Reports, 4, 5566. doi: 10.1038/srep05566.