The European Food Safety Authority (EFSA) has launched a public consultation on new “draft Guidance on the Risk Assessment of Plant Protection Products [PPPs] on Bees (including Apis mellifera, Bombus spp. and solitary bees).” Intended to help applicants and authorities evaluate PPPs “and their active substances under Regulation (EC) 1107/2009,” the draft guidance outlines a process “by which [PPPs] can be evaluated for their potential risk in causing unacceptable harm to a group of non-target organisms (bees).”
To these ends, EFSA has identified a maximum level of harm as defined by Specific Protection Goals (SPGs), which aim to protect the survival and development of bee colonies, preserve biomass and reproduction to ensure long-term survival, and minimize the effect of PPPs on larvae and bee behavior. Recognizing that the viability of a colony depends on the number of bees it contains, the SPGs establish that the magnitude of PPPs’ effects on colonies “should not exceed 7% reduction in colony size” and that forager mortality “should not be increased compared to controls by a factor of 1.5 for 6 days or a factor of 2 for 3 days or a factor of 3 for 2 days.” The SPGs also propose including honey production “as an endpoint measurement in field studies” in addition to the exposure percentiles to be established during the course of the public consultation for each regulatory zone.
The draft guidance thus outlines a risk assessment process involving (i) a preliminary exposure assessment “that yields the Predicted Environmental Concentration (PEC) of the PPP that the bees are exposed to in a severe case,” and (ii) “an effect assessment that compares the degree of harm that can result from exposure of bees to the PEC against the maximum level given by the SPGs.” This risk assessment is spread over multiple tiers, with the First Tier “intended to sift out PPPs that are of negligible risk to bees and so prevent unnecessary testing.” If the First Tier indicates that the PPP in question “potentially presents an unacceptable risk,” however, “either the assessment must be refined by including improved information and/or mitigation measures or the Higher Tier tests are invoked, which involve semi-field and field tests… formulated to reflect the SPGs.” EFSA will accept written comments on the draft guidance until October 25, 2012.