Guidance on aged sorption of pesticides
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Finalised guidance submitted for consideration for adoption for the EU
The finalised guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments has been submitted by CRD for consideration for adoption as technical guidance for the EU. It should be noted that the guidance is currently in a draft stage and holds no official status in pesticides regulatory procedures in the UK or Europe as a whole at the time of writing. Until the guidance is officially noted, it is strongly advised that applicants contact the appropriate regulatory authority to discuss its use beforehand.
History of aged sorption guidance development
Workshop on aged sorption of pesticides in soil (April 2010)
A workshop was held at FERA to assess a proposed new technical guidance document on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments. The proceedings of this workshop on aged sorption of pesticides in soil held in York on 27th – 28th April 2010 are available. The workshop was funded by CRD as part of a research and development project with the aim of drafting guidance on generating and using data on aged sorption of pesticides in soil within regulatory submissions for authorisation of pesticides. The workshop was attended by invited experts from the regulatory, academic and industry communities.
The proceedings consist of:
- A Summary report on the workshop and why it was held.
- The draft guidance document (initial draft as of 2010).
- A document detailing the background research supporting the draft guidance.
- Presentations detailing the development and theory of the draft guidance:
- Introduction of the workshop
- Methods for measuring aged sorption
- Aged sorption - Reliability of estimated model parameters
- Effect of aged-sorption parameters in exposure assessments
- Proposed technical guidance for aged sorption studies
- Use of aged sorption parameters in exposure assessments
- Introduction of breakout session - Day 1
- Introduction of breakout session - Day 2
- The results of workshop discussion groups.
- Original technical notes taken in the workshop discussion groups:
- Day 2:
- and a 'Glossary of terms for guidance' document
EFSA Panel on Plant Protection Products and their Residues: Statement and Opinion
The draft guidance has been subject to assessment by the Panel on Plant Protection Products and their Residues (PPR) of the European Food Safety Authority (EFSA). Based on a statement issued by the PPR, the guidance was redrafted in 2016 to address issues raised in the PPR statement and add additional recommendations on the assessment of metabolites and use of field studies. The 2016 revised guidance was submitted to EFSA in 2016.
This draft has been the subject of a definitive Opinion of the PPR published in 2018. Chemicals Regulation Division (CRD) of HSE have updated the guidance based on the recommendations in the EFSA PPR Opinion (EFSA, 2018). In the Opinion, the EFSA PPR panel (2018) agreed in general with the experimental and modelling approaches that were proposed in the guidance. The EFSA PPR panel (2018) tested the guidance using three substances and concluded that the guidance could generally be well applied and resulted in robust and plausible results. Some revisions of the guidance were requested regarding the interpretation of aged sorption data, and how the data are used in the tiered risk assessment. It should be noted that in contrast to the original draft guidance, this version contains specific recommendations to deal with aged sorption of metabolites.
It should be noted that until the guidance is officially noted, it is strongly advised that applicants contact the appropriate regulatory authority to discuss its use beforehand.
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