Canadian Regulatory Perspective on Next Generation Risk Assessments for Pest Control Products and Industrial Chemicals

Abstract

In 2012, the Council of Canadian Academies published the expert panel on integrated testing of pesticide’s report titled: Integrating emerging technologies into chemical safety assessment. This report was prepared for the Government of Canada in response to a request from the Minister of Health and on behalf of the Pest Management Regulatory Agency. It examined the scientific status of the use of integrated testing strategies for the regulatory health risk assessment of pesticides while noting the data-rich/poor dichotomy that exists when comparing pesticide formulations to most industrial chemicals. It also noted that the adoption of integrated approaches to testing and assessment (IATA) strategies may refine and streamline testing of chemicals, as well as improve results in the future. Moreover, the experts expected to see an increase in the use of integrated testing strategies over the next decade, resulting in improved evidence-based decision-making. Subsequent to this report, there has been great advancements in IATA strategies, which includes the incorporation of adverse outcome pathways (AOPs) and new approach methodologies (NAMs). This perspective provides the first Canadian regulatory update on how Health Canada is also advancing the incorporation of alternative, non-animal strategies, using a weight of evidence approach, for the evaluation of pest control products and industrial chemicals. It will include specific initiatives and describe how this work is leading to the creation of next generation risk assessments. It also reflects Health Canada’s commitment towards implementing the 3Rs of animal testing: reduce, refine and replace the need for animal studies, whenever possible.

Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health

“…Building on experiences and achievements from the CMP to date, the Government of Canada continues to expand on the vision for modernization. This shift takes into consideration new scientific information regarding chemicals to support innovative strategies for priority setting and to maintain a flexible, adaptive and fit-for-purpose approach to risk assessment to manage increasingly diverse and complex substances and mixtures ( HC, 2021b ; Bhuller et al, 2021 ).…”

“…Accordingly, the ESRAP continues to expand the use of computational and in vitro models as well as evidence integration strategies to identify and address emerging priority substances. Key to successful implementation moving forward are the productive partnerships with the international regulatory and research communities to continue to build confidence and harmonization for the use of alternative test methods and strategies in chemical risk assessment ( Krewski et al, 2020 ; Bhuller et al, 2021 ).…”

“… Bhuller et al (2021) provides the first Canadian regulatory perspective on the approach and process towards the implementation of NAMs in Canada for pesticides and industrial chemicals ( Bhuller et al, 2021 ). It acknowledges foundational elements, such as the 2012 Council of Canadian Academies ( CCA, 2012 ) expert panel report, “Integrating Emerging Technologies into Chemical Assessment,” used to establish the overall vision.…”

“…PMRA collaborates with stakeholders on the development of NAMs and their potential implementation for regulatory purposes. For example, PMRA is collaborating with the interested community through several ongoing multi-stakeholder initiatives designed to explore NAMs, at the national and international levels ( Bhuller et al, 2021 ). Another example is several academic-led initiatives along with research and consulting firms that are immersed in developing models, including open-source models.…”

Transforming the evaluation of agrochemicals

“…This enriches the science, ensures that the solutions meet stakeholder needs, and gives stakeholders confidence in the new technology so that they start using it quickly. This approach then is coupled with other processes that translate, for example, case study findings into applications, which rely on frameworks that incorporate both innovation and acceleration 29 . Finally, overcoming blocks to change is not strictly a science‐based issue.…”