Human Health Risk Consideration of Nano-Enabled Pesticides for Industry and Regulators

Previous IUPAC Nanopesticides projects (e.g., projects 2012-020-3-600 and 2016-016-2-600) have developed risk assessment frameworks and key criteria that could help risk assessment processes for nano-enabled pesticides (especially for ecological risk assessments) [1, 2].

While the approach elucidated in the above IUPAC projects is now being considered by regulatory agencies internationally (e.g., US EPA, Environment Canada, APVMA Australia, EFSA Europe), there is a need to expand our thinking and provide more practical information to answer some key questions, such as those listed below:

1. When a new product is presented to regulators, what are the key questions that they would like to ask? This essentially defines the problem formulation step in the health risk assessment framework.

2. What are the key characterization and analytical requirements for the specific product that may be necessary to answer the questions posed as part of Question 1 for a specific product type?

3. What are the specific methods or approaches for human health effects that are readily available and appropriate to answer the questions for the specific product under consideration?

4. What are the current knowledge gaps and uncertainties that the regulators and industry need to consider for a pragmatic approach to decision making?

This project would consist of three phases.

Phase I – Bring together a core group of task members to define the scope of the project, identify specific active ingredients and product types, and undertake problem formulation from the risk assessment perspective.

Phase II – Organize a workshop bringing together expertise from industry, regulatory bodies, and researchers on human health effects and the risk assessment of nano-enabled pesticides, as well as the characterization of nanomaterials that have been identified in phase I.

Phase III – Recommend a sound methodological approach for generating data that is likely to be needed by the regulators. Identify research priorities where current knowledge or methodology are found to be inadequate.

The overall objective is to assist industry, contract research organizations (CROs), and regulators in determining an acceptable and practicable approach for generating the data relevant to human health risk assessment required for the registration of nano-enabled pesticide formulations. Broadly speaking, a nano-enabled pesticide represents a product where nanotechnology is employed (e.g. delivery via a nano-carrier) to enhance efficacy, reduce the environmental footprint, or the enhance usability of a pesticide active ingredient.

For further information, contact the Task Group Chair Linda Johnston <linda.johnston@nrc-cnrc.gc.ca> or Rai Kookana <rai.kookana@csiro.au>

www.iupac.org/project/2017-035-2-600