BACKGROUND
The Need for New Agrochemical Safety Assessment Paradigm
The registration of crop protection products depends on a complex and multifaceted process, which requires authorities to examine the ecological and human safety of pesticides being registered in the context of their use: type of crop, site of application, timing, amount and frequency of use, as well as storage and disposal practices.
The risk assessment must consider potential harm to humans (e.g., occupational risk, risk from dietary exposure, incidental exposure) but also to fish, wildlife and plants, including endangered species and non-target organisms. The risk of contamination of surface and ground water (e.g., via spray-drift, or run-off) should also be evaluated.
The safety evaluation is based on data provided by the registrants, following a set of standard test studies, most of which are conducted on animals. Although this framework has been used for decades, it needs to be rethought and modernized in light of scientific and technological advancements, as well as emerging needs driven by an increasingly uneven and growing population, rising pest pressures, and the impacts of climate change. This modernization not only requires the rapid introduction of new, high quality, flexible, and effective agrochemical crop protection solutions, but also a change in mindset that will facilitate the acceptance of a new paradigm across the globe.
The Mission of HESI’s TEA Committee
To help transform the current evaluation approach for agrochemicals, the Health and Environmental Sciences Institute (HESI) launched an international science Committee to Transform the Evaluation of Agrochemicals (the TEA Committee). This multi-sectoral team was formed with the purpose of driving the adoption of 21st century hazard and risk assessment methods and technologies into normal, accepted regulatory practice and legal frameworks. The mission of the Committee is to “establish a roadmap supporting the development of fit-for-purpose safety evaluation for agrochemicals that is applicable to changing global as well as local needs for evaluation and regulatory decisions that can incorporate relevant evolving science inputs”.
To address this problem, we have developed a conceptual model illustrating the key aspects of a new approach, which will increase the speed, efficiency, and accuracy of agrochemical safety evaluation while further informing the safe use decisions and reducing the use of animals (Figure 1). These precepts are critical to ensure that the evaluation is exposure-based, inclusive of new science, adapted to local and global needs, and fit for purpose through time. It includes a tiered approach which weighs data gaps against potential risks and helps develop data generation strategies to support risk assessment and risk management decisions. The approach also encourages data sharing, efforts to increase transparency, building trust, and encouraging critical thinking of risk assessors and decision-makers. The key precepts of the conceptual model are detailed in Table 1.
Figure 1. Conceptual model illustrating the ten elements or themes that should be addressed to effectively address the problem as stated to lead to a transformation of the evaluation of agrochemicals.
Table 1: Conceptual model elements and corresponding guiding principles
Elements
Guiding Principles (Key attributes for the elements)
Exposure, adaptable, include new science, tiered approach, and data sharing and transparency
1. When taking an exposure-driven, adaptable, and tiered approach, think ‘simple' and what is known (e.g., about adversity (hazard in animals and humans) and prevention (reduced exposure in humans)) before embarking on more complex strategies.
2. Provide ‘SMART’ strategies that are specific, measureable, measurable, relevant, and timebound (i.e., doable in the current context) so that there is a greater likelihood for the strategy to be acceptable and adaptable for regulatory purposes.
3. Consider existing data and risk mitigation and management measures that reduce exposure to the extent possible (e.g., engineering controls), before generating new information.
4. Strive for openness and transparency while respecting laws governing confidential business information and privacy.
* Examples of existing data includes published work, science-based evaluations from regulatory and international authorities responsible for assessing agrochemicals, relevant research including biomonitoring results, and non-animal strategies (e.g., in silico/computational models).
Fit for purpose over time
5. New methodologies and technologies will continue to result in a “data-rich” database for agrochemicals. This includes high quality information to help characterize the hazard and risk for a specific context while keeping in mind the life-cycle approach for these products (i.e., initial application, subsequent registrations (amendments or use expansions), and re-registration/evaluation).
Adapt to global needs
6. Develop fit-for-purpose and robust data packages with a vision for alignment (mutual acceptance of data) and when applicable, harmonization (regulatory decision-making).
Adapt to local needs
7. Develop robust data packages that support local market authorizations thereby allowing access to new technologies that continue to prevent tech gaps.
Create Incentives
8. Develop agrochemicals that are aligned with broader public and global health values, such as climate change.
9. Promote data sharing and open science initiatives.
10. Continue to support global joint review initiatives as a mechanism to align the submission process across nations/ regulatory authorities.
Build trust
11. Adapt systems thinking approaches to allow for all interested and affected parties to play an active role in building regulatory, scientific, and public trust and confidence.
12. Build upon the existing multi-year and stakeholder initiatives while weaving new partnerships.
13. Develop new approaches by upholding integrity, trust, and respect with all interested and implicated parties.
14. Allow time in building relations and for new innovations to continue to develop in parallel to the implementation of this conceptual framework.
15. Given that new methods are designed to be comparable if not better than the existing assays/tools, build training and learning tools that start with the conventional testing strategies and then how new methodologies can be used to replace, refine, or reduce the need for additional testing.