Challenges in Risk Assessment and Management of Veterinary Medicines for Plants: Gaps and Reflections for an Updated Approach
Journal Title: Biomedical Journal of Scientific & Technical Research (BJSTR) - Year 2018, Vol 5, Issue 3
Abstract
Under the current legislation EPC [1], an Environmental Risk Assessment (ERA) is mandatory to obtain Marketing Authorization for Veterinary Medicinal Products (VMP). ERAs for VMP, plant protection products, biocides or industrial technical products, follow the General Protection Goals for ecosystems Devos [2]. It means that the ERA evaluates the environmental relevance of the active substances concentrations estimated in the different environmental compartments taking into account the ecotoxicological effects on representative organisms. Specifically, the guideline for VMP VICH GL 38, [3] mentions that “the overall target of the assessment is the protection of ecosystems”. This General Protection Goal might be sufficient when no risks are identified, but when risks are identified a clearer definition of the protection goals is required in order to refine and manage such risks.Under the current legislation EPC [1], an Environmental Risk Assessment (ERA) is mandatory to obtain Marketing Authorization for Veterinary Medicinal Products (VMP). ERAs for VMP, plant protection products, biocides or industrial technical products, follow the General Protection Goals for ecosystems Devos [2]. It means that the ERA evaluates the environmental relevance of the active substances concentrations estimated in the different environmental compartments taking into account the ecotoxicological effects on representative organisms. Specifically, the guideline for VMP VICH GL 38, [3] mentions that “the overall target of the assessment is the protection of ecosystems”. This General Protection Goal might be sufficient when no risks are identified, but when risks are identified a clearer definition of the protection goals is required in order to refine and manage such risks. The most relevant scenario in the release assessment of VMP to the environment occurs in intensively farmed animal species. The manure produced by these animals is most frequently used across the EU as fertiliser in crops, although some countries may also use manure in grassland. However, during the exposure assessment, the definition of the different agro-livestock scenarios, the target plant species or the plant species that are more vulnerable and need a higher protection are not specific enough, which means that risk assessors have to interpret the General Protection Goals without clear guidance. In our view, the General Protection Goals need to be translated into Operational Protection Goals to achieve efficient and robust ERAs. This can be achieved focusing on the relevant agrolivestock scenarios. This paper aims to identify gaps of ERA of VMPs for terrestrial plants and offers proposals for applicable and suited Operational Protection Goals and Risk management measures. ERA of VMPs for Terrestrial Plants Considerable efforts were devoted in the past years to improve the ERA of VMPs for terrestrial plants resulting in a specific guideline where plant evaluation was refined EMA [4]. According to this, the effects of a VMP on plants are first assessed taking into account a deterministic approach (lower ecotoxicity end point from studies on 6 crop species belonging to different families).If a risk is found at this level the effects have to be refined in a higher tier by means of a probabilistic approach using the lower limit of the 5th percentile (LLHC5) of the ecotoxicity data distribution for 8 crop species. If the risk persists, then Risk Mitigation Measures (RMM) that reduces the exposure might be included in the Summary of Product Characteristics (SPC). If the RMM don’t reduce the identified risk to an acceptable level, the benefits of the authorization must be weighed against the risks before an approval can be granted EPC [1]. Although the described procedure is a valuable tool, the risk for plants continues to be a critical point on the ERA of VMPs Kuster and Adler [5].
Authors and Affiliations
De la Torre A, Haro A, Carballo M, Rubio C, Cortés G, Carapeto R
Keywords
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- EP ID EP591722
- DOI 10.26717/BJSTR.2018.05.001198
- Views 207
- Downloads 0
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