Council of Canadian Academies Releases an Expert Panel Report on the Adoption of Integrated Strategies in Chemical Assessment

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Council of Canadian Academies Releases an Expert Panel Report on the Adoption of Integrated Strategies in Chemical Assessment

Catherine Willett, Humane Society of the United States

Published: February 7, 2012

The Council of Canadian Academies (CCA) has published a report outlining the integration of emerging technologies into Canadian chemical assessment programs. Sparked in part by concern over the lack of information on a large number of chemicals, including the non-active ingredients in pesticides, the Minister of Health (on behalf of the Pest Management Regulatory Agency) requested that the Council look into approaches that could more efficiently and effectively assess chemical safety.

The expert panel assembled by the CCA was tasked with answering the question: “What is the scientific status of the use of integrated testing strategies in the human and environmental regulatory risk assessment of pesticides?”

Many of the current toxicity tests, based largely on testing in animals, were developed over 30 years ago and have changed little since. Although methods are not yet available to completely replace the current paradigm, significant advances are being made quickly, with integrated strategies being increasingly adopted, even to inform data-rich chemicals. The emerging technologies, integrated with existing data, are seen as a “pragmatic means to increase information gathering efficiency” in the short term and as a bridge to the transition to a hypothesis-driven approach to testing and assessment in the longer term. The report discusses the current use of integrated approaches to testing and assessment (IATA), and describes the state of the science of several of the predictive and interpretive tools being developed.

This report builds nicely on efforts at the US EPA’s Office of Pesticide Programs on integrated approaches to testing and assessment and at the Organization for Economic Cooperation and Development, which has held workshops and focused sessions on the applicability of IATAs. The detailed report provides a primer on the elements necessary for constructing an integrated strategy, including example database structures, Quantitative Structure Activity Relationships (QSAR), Adverse Outcome Pathways, Physiologically Based Pharmacokinetic Modeling, and High-Throughput Screening. It provides examples of case studies of how these elements and tools can be applied. In addition, the report lays the foundation for harmonized chemicals assessment between Health Canada, the US EPA, and other international regulatory programs. The report is also noteworthy for its comprehensive assessment of potential impacts on the public’s perception and confidence in regulatory risk assessment if integrated testing strategies were implemented.

An Executive Summary of the Report presents the Panel’s findings divided into three sub-topics and summarizes the findings as follows:

  • What is the state of the science of the tools and data sources associated with integrated testing strategies?
  • What is the current status of the use of integrated testing strategies for the risk assessment of pesticides, pharmaceuticals, industrial chemicals, and other chemical substances by regulatory agencies around the world?
  • Could there be potential impacts on the public’s perception and confidence in regulatory risk assessment and risk management decisions for pesticides if integrated testing strategies were implemented?
Summary

“Recent estimates suggest that toxicity data are lacking for 87 per cent of chemicals on the market (reviewed in Hartung, 2009). While the toxicological base supporting the safety of some chemicals, such as pesticide active ingredients, is extensive and has contributed significantly to our understanding of the toxicology of these products, on a practical level it cannot be applied to the tens of thousands of chemicals that regulatory agencies worldwide must now categorize. Consequently, there is a significant gap between expectation and capacity in toxicity testing, and an urgent need for new approaches that are more predictive, more reliable, faster, less expensive, and that provide mechanism-based, chemical-specific toxicity information in order to better inform human health risk assessment.

In May 2009, the Pest Management Regulatory Agency (PMRA) of Health Canada asked the Council of Canadian Academies to appoint an expert panel to answer the following question: “What is the scientific status of the use of integrated testing strategies in the human and environmental regulatory risk assessment of pesticides?” Although a complete set of alternative methods that could replace the entire current testing paradigm does not yet exist, the state of the science is evolving rapidly, and the Panel expects to see a global evolution toward the use of integrated testing strategies in decision-making, with the anticipation that this will better inform decisions for both data-rich chemicals and data-poor chemicals, over the next two to 10 years. The Panel expects that the regulatory deployment of Integrated Approaches to Testing and Assessment (IATA) will vary depending on the types of chemicals and the nature of the decision-making process that the data are intended to inform.

The potential risks associated with exposure to pesticides are already a particular worry for many people, and adoption of new IATA strategies in regulatory processes are almost certain to further underscore and exacerbate these concerns. Regulators must recognize the need to engage the public in meaningful dialogue in order to provide assurance that the new IATA approaches seek to reduce overall uncertainties in the assessment of chemical risk. Moreover, that these changes will provide more reliable assessments of potential risks to human health and the environment, rather than to simply streamline processes and sacrifice safety for social or economic benefits.”