Tag Archives: PMRA

Canada, emerging technologies, and chemical assessments (pesticides)

The Council of Canadian Academies released a report titled, Integrating Emerging Technologies into Chemical Safety Assessment, on Jan. 12, 2012. It wasn’t what I thought it might be.

Before launching into the report, it might be helpful to know something more about the Council of Canadian Academies. (Shockingly, I can’t find a description of the group in the postings where I’ve mentioned them previously.) From the Council’s About Us page (Mar.23.12 Note: I have removed links to the Council’s Board of Governors, etc.),

The Council is an independent, not-for-profit corporation that supports science-based, expert assessments (studies) to inform public policy development in Canada. The Council began operation in 2005 and consists of a Board of Governors,  a Scientific Advisory Committee and Secretariat. The Council draws upon the intellectual capital that lies within its three Member Academies the Royal Society of Canada (RSC); the Canadian Academy of Engineering; and the Canadian Academy of Health Sciences.

Our mission is to contribute to the shaping of evidence-based public policy that is in the public interest. This is achieved by appointing independent, multidisciplinary panels of expert volunteers. The Council’s work encompasses a broad definition of science, incorporating the natural, social and health sciences as well as engineering and the humanities.

This latest report on emerging technologies and chemical assessments is in fact a report on emerging technologies for  health and safety assessment procedures of toxic chemicals using pesticides as a test case. Here’s the reasoning (from the abridged version of the report, Report in Focus; Integrating Emerging Technologies into Chemical Safety Assessment),

Protecting human health and the environment is of paramount importance to Canadians. As such, there has been an increasing demand for improved regulation of chemicals in Canada. Nevertheless, recent estimates suggest that toxicity data are lacking for over three quarters of the chemicals on the market. In fact, this paucity of data can extend to the other components within a chemical product. For example, the active ingredients in pesticides are among the most stringently regulated compounds on the market; however, the final pesticide product may also contain data-poor formulants. Added to enhance the use or increase the stability of the pesticide product, formulants are not typically subjected to the full battery of toxicity tests that the active ingredients must undergo.

The data-rich and data-poor nature of pesticide formulation is a metaphor for the dichotomy that exists for most industrial chemicals. While there are some substances for which we have an enormous amount of data, such as pesticide active ingredients, the vast majority of industrial chemicals are extremely data-poor. (p. 1)

This specific report was commissioned by the Minister of Health. From the Report in Focus; Integrating Emerging Technologies into Chemical Safety Assessment,

All levels of government in Canada play a role in regulating the sale and use of pesticides; however, the federal government is responsible for the registration of pest control products in Canada. In May 2009, the Minister of Health, on behalf of the Pest Management Regulatory Agency (PMRA), approached the Council of Canadian Academies to appoint an expert panel to answer the question:

“What is the scientific status of the use of integrated testing strategies in the human and environmental regulatory risk assessment of pesticides.”

In response to this question, the Council assembled a multidisciplinary panel of 15 eminent experts from Canada and the United States. (p. 3)

Here’s a list of the members of the Expert Panel (from the Executive Summary; Integrating Emerging Technologies into Chemical Safety Assessment),

The Expert Panel on the Integrated Testing of Pesticides

Leonard Ritter (Chair) Executive Director, Canadian Network of Toxicology Centres; and Professor of Toxicology, University of Guelph (Guelph, ON)

Christopher P. Austin Director, Chemical Genomics Center, National Institutes of Health (Bethesda, MD)

John R. (Jack) Bend Distinguished University Professor, Departments of Pathology; Physiology and Pharmacology; and Paediatrics in the Schulich School of Medicine and Dentistry, University of Western Ontario (London, ON)

Conrad G. Brunk Professor of Philosophy, University of Victoria (Victoria, BC)

Timothy Caulfield, FRSC, FCAHS Professor, Faculty of Law and School of Public Health; Research Director, Health Law Institute; and Canada Research Chair in Health Law and Policy, University of Alberta (Edmonton, AB)

Vicki L. Dellarco Science Advisor, Office of Pesticide Programs, United States Environmental Protection Agency (Washington, DC)

Paul A. Demers Director, School of Environmental Health, College for Interdisciplinary Studies; and Professor, School of Population & Public Health, Faculty of Medicine, University of British Columbia (Vancouver, BC)

Warren Foster Professor, Department of Obstetrics and Gynaecology; and Director, Centre for Reproductive Care, McMaster University Health Sciences Centre (Hamilton, ON)

Claire Infante-Rivard Professor, Department of Epidemiology, Biostatistics and Occupational Health, Faculty of Medicine, McGill University (Montréal, QC)

Catherine Jumarie Professor, Department of Biological Sciences, Université du Québec à Montréal (Montréal, QC)

Sam Kacew Associate Director of Toxicology, R. Samuel McLaughlin Centre for Population Health Risk Assessment, Institute of Population Health, University of Ottawa (Ottawa, ON)

Robert J. Kavlock Director, National Center for Computational Toxicology, United States Environmental Protection Agency (Durham, NC)

Daniel Krewski Director, R. Samuel McLaughlin Centre for Population Health Risk Assessment, Institute of Population Health, University of Ottawa (Ottawa, ON)

Paul G. Mezey Canada Research Chair in Scientific Modelling and Simulation, Memorial University of Newfoundland (St. John’s, NL)

Terry W. Schultz Emeritus Professor, Department of Comparative Medicine, College of Veterinary Medicine, University of Tennessee (Knoxville, TN) (p. 7)

Getting to the point (from the Executive Summary),

“The issues inherent in the current approach to chemical testing are two-fold: to address the lack of toxicity data for the vast majority of industrial chemicals and to recognize that regulatory decisions must be based on the best available science. The Panel believes that these challenges can be best met by adopting an Integrated Approach to Testing and Assessment (IATA).” – Leonard Ritter, Chair of the Expert Panel (p. 4)

As for what that means,

Integrated Approaches to Testing and Assessment (IATA) represent a pragmatic approach that will move toxicology away from describing what happens towards an explanation of how it happens. Toxicity testing will no longer depend on the one-size-fits-all hazard-based checklist of tests currently used but rather be based on a refined and focused testing strategy tailored to the toxicity profile and intended use of the chemical in question. An IATA strategy uses a tiered approach to help categorize and prioritize higher risk chemicals; all of the existing data on a substance are compiled at the start of the testing process in order to evaluate what data gaps exist and what testing approaches would be most appropriate to understand the precise toxicological profile of that substance.

Given my interest in the toxicological impacts of nanomaterials and concerns about responding to uncertainty and risk in a timely and appropriate fashion, this approach seems promising. Of course, the recommendations may or may not be accepted and, even then, there’s no telling what implementation would look like. Still, I am encouraged.

You can find a full list of all the documents (Report, Report in Focus, Executive Summary, etc.) here.