By Carla N. Hutton

The European Food Safety Authority (EFSA) announced on March 15, 2021, that it has begun a public consultation on a draft updated Guidance on the assessment of exposure of operators, workers, residents, and bystanders in risk assessment for plant protection products (PPP).  According to EFSA, the Guidance is designed to assist risk assessors and applicants when quantifying potential non-dietary, systemic exposures as part of the regulatory risk assessment for PPPs.  The Guidance is based on the Scientific Opinion on “Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Residents and Bystanders” developed by the EFSA Panel on Plant Protection Products and their Residues (PPR) in 2010.  EFSA states that highlighting some inconsistencies between the approaches adopted by regulatory authorities, the PPR Panel proposed a number of changes to the practices in use (i.e., use of deterministic methods for individual PPPs; need to perform an acute risk assessment for PPPs that are acutely toxic; use of appropriate percentile for acute or longer term risk assessments).  In the first version of the Guidance, issued in 2014, EFSA included several scenarios for outdoor uses, with an annexed calculator, as well as recommendations for further research.  EFSA has updated the Guidance in 2021 to include additional scenarios and revise default values on the basis of the evaluation of additional evidence.  To support users in performing the assessment of exposure and risk, EFSA further developed an online calculator that reflects the Guidance content.  Comments on the draft updated Guidance are due May 9, 2021.  EFSA will assess all comments submitted in line with the specified criteria.  The relevant EFSA Panel will further consider the comments and take them into consideration if found to be relevant.

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By Lisa R. Burchi

The European Commission (EC) Standing Committee on Plants, Animals, Food and Feed has issued a guidance document entitled Draft Guidance Document on the Interpretation of the Transitional Measures for the Data Requirements for Chemical Active Substances and Plant Protection Products according to Regulation (EU) No. 283/2013 and Regulation (EU) No. 284/2013. Following the adoption in 2009 of Regulation (EC) No. 1107/2009 concerning the placing of plant protection products (PPP), additional regulations were adopted to establish the necessary data requirements for active substances and PPPs. In 2013, Regulation (EU) No. 283/2013 (amended by Regulation (EU) No. 1136/2014) updated the data requirements for active substances, while Regulation (EU) No. 284/2013 updated data requirements for products. These Regulations include transitional measures to explain when certain applications can rely upon former data requirements and when the updated data requirements must be satisfied.

The Guidance provides two charts describing the transitional measures for: (1) applications for approval, renewal, or approval or amendment of approval of Active Substances; and (2) applications for authorization, renewal of authorization, or amendment of authorization of Plant Protection Products. Each chart describes the type of application at issue and the resulting data requirements. For authorization applications, the Guidance divides the types of applications and resulting data requirements into four active substances categories: (1) AIR-2 active substances; (2) AIR-3 active substances/substances not yet renewed; (3) new active substances; and (4) mixtures.

The Guidance was developed to assist EU Member States in consistently applying and interpreting these transitional measures. Many of the data requirement decisions depend on the type of active substances and whether an application is submitted before or after December 31, 2015, so companies considering or planning to submit applications should review the Guidance carefully to determine what data requirements may be applicable.
 

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